Back to resultsEffects of the V1a Agonist FE 202158 in Patients With Septic Shock
Primary Purpose
Septic Shock
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
FE 202158 1.25
FE 202158 2.5
FE 202158 3.75
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Septic Shock focused on measuring V1a agonist
Eligibility Criteria
Inclusion Criteria:
- Signed informed consent form by the patient or a legal representative according to local regulations
- Man or woman 18 years of age or older
- Proven or suspected infection
- Low blood pressure
- Signs of decreased circulation in the tissues
- Willing to use an adequate barrier method or hormonal method of contraception, if not abstinent, from the day of informed consent to one week after the end of infusion of study medication.
Exclusion Criteria:
- Present or a history (within the last 5 years) of acute coronary syndrome (myocardial infarction or unstable angina). Patients who have been asymptomatic for 6 months after coronary revascularisation are eligible.
- Hypovolaemia suspected on clinical grounds, e.g. cold extremities with delayed capillary filling, low cardiac filling pressure, marked systolic or pulse pressure variation or positive leg raising test.
- Known or suspected cardiac failure
- Pregnancy or breastfeeding
- Any cause of hypotension other than early septic shock
- Use of vasopressin or terlipressin for blood pressure support during the current hospital admission
- Proven or suspected acute mesenteric ischemia, as judged by the investigator
- Known episode of septic shock within 1 month prior to randomisation
- Underlying chronic heart disease
- Traumatic brain injury
- Present hospitalisation with burn injury
- Symptomatic peripheral vascular disease including Raynaud's syndrome
- Previously randomized in this trial
- Intake of an investigational drug within the last 3 months (or longer if judged by the Investigator to possibly influence the outcome of the current study)
- Known participation in another clinical trial
- Considered by the investigator to be unsuitable to participate in the trial for any other reason
Sites / Locations
- Christiana Care Health System
- Baystate Medical Center
- Division of Education and Research SMDC Health System
- Cooper University Hospital
- Mount Sinai School of Medicine
- Baylor College of Medicine
- Clinique Universitaire St-Luc
- Erasme Hospital (Free University of Brussels)
- University Hospital Vrije Universiteit
- Service des Soins Intensits
- Royal Columbian Hospital
- St. Paul´s Hospital
- Bispebjerg Hospital
- Rigshospitalet
- Hillerød Hospital
- Hvidovre Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
FE 202158 1.25
FE 202158 2.5
FE 202158 3.75
PLCBO
Arm Description
Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min. FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use.
Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min. FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use.
Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 3.75 ng/kg/min. FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use.
Patients in the arm received an intravenous infusion for up to 7 days of placebo.
Outcomes
Primary Outcome Measures
Proportion of Patients Maintaining Target Mean Arterial Pressure (MAP) (>60 mmHg) With no Open Label NE (Norepinephrine)
Data were evaluated for target MAP of ≥ 60 mmHg. A 95% confidence interval (CI) was calculated and presented using Clopper-Pearson method.
The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome.
Proportion of Patients Maintaining Target MAP (>60) Irrespective of Open Label NE
Data were evaluated for target MAP of ≥ 60 mmHg. A 95% confidence interval (CI) was calculated and presented using Clopper-Pearson method.
The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome.
Cumulative Dose of Open Label NE.
Cumulative Dose of Open Label NE over 7 days.
The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome.
Infusion Rates of Open Label NE.
Mean open label NE infusion rate within each predefined time period.
The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome.
Secondary Outcome Measures
Pharmacokinetic (PK) Parameter in Patients : Steady State Concentration
PK parameters were calculated using nonlinear 2-compartment population PK model with random patient effects on clearance and volume of distribution.
The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome.
PK Parameter in Patients : Time to Steady State
PK parameters were calculated using nonlinear 2-compartment population PK model with random patient effects on clearance and volume of distribution.
The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome.
PK Parameter in Patients : Clearance
PK parameters were calculated using nonlinear 2-compartment population PK model with random patient effects on clearance and volume of distribution.
The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome.
PK Parameter in Patients : Steady State Volume of Distribution
PK parameters were calculated using nonlinear 2-compartment population PK model with random patient effects on clearance and volume of distribution.
The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome.
PK Parameter in Patients : Initial Elimination Half-life
PK parameters were calculated using nonlinear 2-compartment population PK model with random patient effects on clearance and volume of distribution.
The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome.
PK Parameter in Patients : Terminal Elimination Half-life
PK parameters were calculated using nonlinear 2-compartment population PK model with random patient effects on clearance and volume of distribution.
The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome.
Change From Baseline in C-reactive Protein (CRP)
The change from Baseline in CRP levels were analysed and presented as per the planned time points.
The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome.
Change From Baseline in Tumor Necrosis Factor (TNF)-Alpha
The change from Baseline in TNF-alpha levels were analysed and presented as per the planned time points.
The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome.
Change From Baseline in Interleukin-6 (IL-6)
The change from Baseline in IL-6 levels were analysed and presented as per the planned time points.
The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome.
Change From Baseline in Interleukin-10 (IL-10)
The change from Baseline in IL-10 levels were analysed and presented as per the planned time points.
The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome.
Change From Baseline in Interleukin-1 Receptor (IL-1R) Antagonist
The change from Baseline in IL-1R levels were analysed and presented as per the planned time points.
The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome.
Change From Baseline in Heart Rate
The change from Baseline in heart rate was analysed and presented as per the planned time points.
The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome.
Change From Baseline in Fluid Balance
The change from Baseline in fluid balance were analysed and presented as per the planned time points. The fluid balance was adjusted for length of time interval and weight.
The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome.
SOFA Score
The SOFA score, is used to track a patient's status during the stay in an intensive care unit. This scoring system is used to determine the extent of a person's organ function or rate of failure. The scoring system comprise of scores for six different system: Respiratory System; Nervous System; Cardiovascular System; Liver; Coagulation; and Renal System. Score for each system ranges from 0-4 (0=normal, 4=worst).
Total SOFA score is a sum of the individual system score and range from 0 to 24, 0 being the better and 24 being the worst patient status.
The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome.
Pulmonary Function : Change From Baseline in PaO2/FiO2
Change from Baseline in PaO2/FiO2 was observed at each time-point.
The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome.
Pulmonary Function : Change From Baseline in Tidal Volume
Change from Baseline in tidal volume was observed at each time-point.
The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome.
Change From Baseline in Arterial Blood Gas (Lactate)
Change from Baseline in arterial blood gas (lactate) was observed at each time-point.
The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome.
Days Alive and Free of Any Organ Dysfunction at Day 7
Percentage of days alive and free of any organ dysfunction (i.e. no. of days divided by 7).
The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome.
Percentage of Patients Alive and Free of All Vasopressors
Percentage of patients alive and free of all vasopressors was assessed on Days 7, 14, and 28.
The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome.
Percentage of Days Alive and Free of Dialysis
Percentage of days alive and free of dialysis was assessed on Days 7, 14, and 28.
The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome.
Percentage of Days Alive and Free of Ventilation
Percentage of days alive and free of ventilation was assessed on Days 7, 14, and 28.
The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome.
Mortality
Mortality was assessed as percentage of patients dead at pre-specified time points.
The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome.
Incidence of Abnormal Changes in ECG
The number of patients having abnormal changes in ECG variables during the trial period was presented.
The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome.
Full Information
NCT ID
NCT01000649
First Posted
September 30, 2009
Last Updated
August 24, 2017
Sponsor
Ferring Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT01000649
Brief Title
Effects of the V1a Agonist FE 202158 in Patients With Septic Shock
Official Title
Infusion Proof-of-concept Trial Investigating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Ascending Doses of FE 202158 in Patients With Vasodilatory Hypotension in Early Septic Shock
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
September 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ferring Pharmaceuticals
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this trial was to examine the safety and tolerability, pharmacokinetics of FE 202158 and to assess whether it can stabilize blood pressure and reduce vascular (blood vessel) leakage. FE 202158 had previously been tested in healthy volunteers.
Detailed Description
This was a multi-centre, double-blind, randomized, placebo-controlled, parallel group trial investigating the safety, tolerability, pharmacokinetics, and pharmacodynamics of FE 202158 (using three ascending doses) in patients with vasodilatory hypotension in early septic shock, when given as continuous infusion for up to 7 days.
The trial comprised of three treatment arms where FE 202158 was administered in 1.25 ng, 2.5 ng and 3.75 ng dose, respectively. A placebo arm was also included in the trial where patients received isotonic saline.
Efficacy of FE 202158 was determined by evaluating its ability to maintain mean arterial pressure (MAP) >60 mmHg and its modulating effect on inflammatory markers. Effects of FE 202158 on other variables like vital signs, morbidity, mortality and pulmonary function were also determined.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Septic Shock
Keywords
V1a agonist
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
53 (Actual)
8. Arms, Groups, and Interventions
Arm Title
FE 202158 1.25
Arm Type
Experimental
Arm Description
Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.
FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use.
Arm Title
FE 202158 2.5
Arm Type
Experimental
Arm Description
Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.
FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use.
Arm Title
FE 202158 3.75
Arm Type
Experimental
Arm Description
Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 3.75 ng/kg/min.
FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use.
Arm Title
PLCBO
Arm Type
Placebo Comparator
Arm Description
Patients in the arm received an intravenous infusion for up to 7 days of placebo.
Intervention Type
Drug
Intervention Name(s)
FE 202158 1.25
Intervention Description
FE 202158 at dose 1.25 ng/kg/min infused.
Intervention Type
Drug
Intervention Name(s)
FE 202158 2.5
Intervention Description
FE 202158 at dose 2.5 ng/kg/min infused.
Intervention Type
Drug
Intervention Name(s)
FE 202158 3.75
Intervention Description
FE 202158 at dose 3.75 ng/kg/min infused.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Isotonic saline infused.
Primary Outcome Measure Information:
Title
Proportion of Patients Maintaining Target Mean Arterial Pressure (MAP) (>60 mmHg) With no Open Label NE (Norepinephrine)
Description
Data were evaluated for target MAP of ≥ 60 mmHg. A 95% confidence interval (CI) was calculated and presented using Clopper-Pearson method.
The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome.
Time Frame
Day 1 up to Day 7
Title
Proportion of Patients Maintaining Target MAP (>60) Irrespective of Open Label NE
Description
Data were evaluated for target MAP of ≥ 60 mmHg. A 95% confidence interval (CI) was calculated and presented using Clopper-Pearson method.
The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome.
Time Frame
Day 1 up to Day 7
Title
Cumulative Dose of Open Label NE.
Description
Cumulative Dose of Open Label NE over 7 days.
The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome.
Time Frame
Day 1 up to Day 7
Title
Infusion Rates of Open Label NE.
Description
Mean open label NE infusion rate within each predefined time period.
The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome.
Time Frame
Day 1 up to Day 7
Secondary Outcome Measure Information:
Title
Pharmacokinetic (PK) Parameter in Patients : Steady State Concentration
Description
PK parameters were calculated using nonlinear 2-compartment population PK model with random patient effects on clearance and volume of distribution.
The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome.
Time Frame
Day 1 up to Day 7
Title
PK Parameter in Patients : Time to Steady State
Description
PK parameters were calculated using nonlinear 2-compartment population PK model with random patient effects on clearance and volume of distribution.
The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome.
Time Frame
Day 1 up to Day 7
Title
PK Parameter in Patients : Clearance
Description
PK parameters were calculated using nonlinear 2-compartment population PK model with random patient effects on clearance and volume of distribution.
The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome.
Time Frame
Day 1 up to Day 7
Title
PK Parameter in Patients : Steady State Volume of Distribution
Description
PK parameters were calculated using nonlinear 2-compartment population PK model with random patient effects on clearance and volume of distribution.
The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome.
Time Frame
Day 1 up to Day 7
Title
PK Parameter in Patients : Initial Elimination Half-life
Description
PK parameters were calculated using nonlinear 2-compartment population PK model with random patient effects on clearance and volume of distribution.
The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome.
Time Frame
Day 1 up to Day 7
Title
PK Parameter in Patients : Terminal Elimination Half-life
Description
PK parameters were calculated using nonlinear 2-compartment population PK model with random patient effects on clearance and volume of distribution.
The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome.
Time Frame
Day 1 up to Day 7
Title
Change From Baseline in C-reactive Protein (CRP)
Description
The change from Baseline in CRP levels were analysed and presented as per the planned time points.
The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome.
Time Frame
Day 1 up to Day 7
Title
Change From Baseline in Tumor Necrosis Factor (TNF)-Alpha
Description
The change from Baseline in TNF-alpha levels were analysed and presented as per the planned time points.
The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome.
Time Frame
At Day 1, Day 2, Day 4, and Day 7
Title
Change From Baseline in Interleukin-6 (IL-6)
Description
The change from Baseline in IL-6 levels were analysed and presented as per the planned time points.
The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome.
Time Frame
At Day 1, Day 2, Day 4, and Day 7
Title
Change From Baseline in Interleukin-10 (IL-10)
Description
The change from Baseline in IL-10 levels were analysed and presented as per the planned time points.
The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome.
Time Frame
At Day 1, Day 2, Day 4, and Day 7
Title
Change From Baseline in Interleukin-1 Receptor (IL-1R) Antagonist
Description
The change from Baseline in IL-1R levels were analysed and presented as per the planned time points.
The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome.
Time Frame
At Day 1, Day 2, Day 4, and Day 7
Title
Change From Baseline in Heart Rate
Description
The change from Baseline in heart rate was analysed and presented as per the planned time points.
The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome.
Time Frame
Day 1 up to Day 7
Title
Change From Baseline in Fluid Balance
Description
The change from Baseline in fluid balance were analysed and presented as per the planned time points. The fluid balance was adjusted for length of time interval and weight.
The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome.
Time Frame
Day 1 up to Day 7
Title
SOFA Score
Description
The SOFA score, is used to track a patient's status during the stay in an intensive care unit. This scoring system is used to determine the extent of a person's organ function or rate of failure. The scoring system comprise of scores for six different system: Respiratory System; Nervous System; Cardiovascular System; Liver; Coagulation; and Renal System. Score for each system ranges from 0-4 (0=normal, 4=worst).
Total SOFA score is a sum of the individual system score and range from 0 to 24, 0 being the better and 24 being the worst patient status.
The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome.
Time Frame
Day 1 up to Day 7, Day 14 and Day 29
Title
Pulmonary Function : Change From Baseline in PaO2/FiO2
Description
Change from Baseline in PaO2/FiO2 was observed at each time-point.
The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome.
Time Frame
Day 1 up to Day 7
Title
Pulmonary Function : Change From Baseline in Tidal Volume
Description
Change from Baseline in tidal volume was observed at each time-point.
The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome.
Time Frame
Day 1 up to Day 7
Title
Change From Baseline in Arterial Blood Gas (Lactate)
Description
Change from Baseline in arterial blood gas (lactate) was observed at each time-point.
The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome.
Time Frame
Day 1 up to Day 7
Title
Days Alive and Free of Any Organ Dysfunction at Day 7
Description
Percentage of days alive and free of any organ dysfunction (i.e. no. of days divided by 7).
The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome.
Time Frame
At Day 7
Title
Percentage of Patients Alive and Free of All Vasopressors
Description
Percentage of patients alive and free of all vasopressors was assessed on Days 7, 14, and 28.
The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome.
Time Frame
At Day 7, Day 14 and Day 28
Title
Percentage of Days Alive and Free of Dialysis
Description
Percentage of days alive and free of dialysis was assessed on Days 7, 14, and 28.
The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome.
Time Frame
At Day 7, Day 14 and Day 28
Title
Percentage of Days Alive and Free of Ventilation
Description
Percentage of days alive and free of ventilation was assessed on Days 7, 14, and 28.
The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome.
Time Frame
At Day 7
Title
Mortality
Description
Mortality was assessed as percentage of patients dead at pre-specified time points.
The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome.
Time Frame
At Day 1, 7, 14, and 28
Title
Incidence of Abnormal Changes in ECG
Description
The number of patients having abnormal changes in ECG variables during the trial period was presented.
The patients (n=2) in the FE 202158 3.75 ng/kg/min dose group were both discontinued within 5 hours after start of infusion. Therefore, no adequate data was available to perform the analysis for the outcome.
Time Frame
Day 1 up to Day 7
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Signed informed consent form by the patient or a legal representative according to local regulations
Man or woman 18 years of age or older
Proven or suspected infection
Low blood pressure
Signs of decreased circulation in the tissues
Willing to use an adequate barrier method or hormonal method of contraception, if not abstinent, from the day of informed consent to one week after the end of infusion of study medication.
Exclusion Criteria:
Present or a history (within the last 5 years) of acute coronary syndrome (myocardial infarction or unstable angina). Patients who have been asymptomatic for 6 months after coronary revascularisation are eligible.
Hypovolaemia suspected on clinical grounds, e.g. cold extremities with delayed capillary filling, low cardiac filling pressure, marked systolic or pulse pressure variation or positive leg raising test.
Known or suspected cardiac failure
Pregnancy or breastfeeding
Any cause of hypotension other than early septic shock
Use of vasopressin or terlipressin for blood pressure support during the current hospital admission
Proven or suspected acute mesenteric ischemia, as judged by the investigator
Known episode of septic shock within 1 month prior to randomisation
Underlying chronic heart disease
Traumatic brain injury
Present hospitalisation with burn injury
Symptomatic peripheral vascular disease including Raynaud's syndrome
Previously randomized in this trial
Intake of an investigational drug within the last 3 months (or longer if judged by the Investigator to possibly influence the outcome of the current study)
Known participation in another clinical trial
Considered by the investigator to be unsuitable to participate in the trial for any other reason
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Development Support
Organizational Affiliation
Ferring Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Christiana Care Health System
City
Newark
State/Province
Delaware
Country
United States
Facility Name
Baystate Medical Center
City
Springfield
State/Province
Massachusetts
Country
United States
Facility Name
Division of Education and Research SMDC Health System
City
Duluth
State/Province
Minnesota
Country
United States
Facility Name
Cooper University Hospital
City
Camden
State/Province
New Jersey
Country
United States
Facility Name
Mount Sinai School of Medicine
City
New York
State/Province
New York
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
Country
United States
Facility Name
Clinique Universitaire St-Luc
City
Brussels
Country
Belgium
Facility Name
Erasme Hospital (Free University of Brussels)
City
Brussels
Country
Belgium
Facility Name
University Hospital Vrije Universiteit
City
Brussels
Country
Belgium
Facility Name
Service des Soins Intensits
City
Dinant
Country
Belgium
Facility Name
Royal Columbian Hospital
City
Vancouver
Country
Canada
Facility Name
St. Paul´s Hospital
City
Vancouver
Country
Canada
Facility Name
Bispebjerg Hospital
City
Bispebjerg
Country
Denmark
Facility Name
Rigshospitalet
City
Copenhagen
Country
Denmark
Facility Name
Hillerød Hospital
City
Hillerød
Country
Denmark
Facility Name
Hvidovre Hospital
City
Hvidovre
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
28807037
Citation
Russell JA, Vincent JL, Kjolbye AL, Olsson H, Blemings A, Spapen H, Carl P, Laterre PF, Grundemar L. Selepressin, a novel selective vasopressin V1A agonist, is an effective substitute for norepinephrine in a phase IIa randomized, placebo-controlled trial in septic shock patients. Crit Care. 2017 Aug 15;21(1):213. doi: 10.1186/s13054-017-1798-7.
Results Reference
result
PubMed Identifier
22961865
Citation
Rehberg S, Yamamoto Y, Sousse L, Bartha E, Jonkam C, Hasselbach AK, Traber LD, Cox RA, Westphal M, Enkhbaatar P, Traber DL. Selective V(1a) agonism attenuates vascular dysfunction and fluid accumulation in ovine severe sepsis. Am J Physiol Heart Circ Physiol. 2012 Nov 15;303(10):H1245-54. doi: 10.1152/ajpheart.00390.2012. Epub 2012 Sep 7.
Results Reference
derived
Learn more about this trial
Effects of the V1a Agonist FE 202158 in Patients With Septic Shock
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