search
Back to results

Investigating FE 202158 as Potential Primary Treatment in Patients With Early Septic Shock

Primary Purpose

Septic Shock

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
FE 202158
Sponsored by
Ferring Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Septic Shock

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Signed informed consent form by the patient or a legal representative according to local regulations'
  • Man or women 18 years of age or older
  • Body weight below 115 kg for male patients and 100 kg for female patients
  • Proven or suspected infection
  • Septic shock, i.e. vasodilatory hypotension requiring vasopressor support
  • Willing to use an adequate barrier method or hormonal method of contraception, if not abstinent, from informed consent to one week after the end of infusion of study medication

Exclusion Criteria:

  • Present or a history within the last 6 months of symptoms of acute coronary syndrome (myocardial infarction or unstable angina)
  • Known or suspected endocarditis
  • 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
  • Known or suspected infection with (HIV)-1, HIV-2, hepatitis B, or hepatitis C
  • Pregnancy or breastfeeding
  • Any cause of hypotension other than early septic shock
  • Use of vasopressin or terlipressin within 7 days prior to start of IMP infusion
  • Proven or suspected acute mesenteric ischemia, as judged by the investigator
  • Known episode of septic shock within 1 month prior to screening
  • Death anticipated within 24 hours, or due to the underlying disease within 3 months
  • Known past or current 2nd and 3rd degree AV-block without a well functioning pacemaker
  • Brain injury within current hospitalisation
  • Present hospitalisation with burn injury
  • Symptomatic peripheral vascular disease including Raynaud's syndrome
  • Previously included in this trial
  • Intake of an Investigational Medicinal Product (IMP) 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 interventional clinical trial
  • Considered by the investigator to be unsuitable to participate in the trial for any other reason

Sites / Locations

  • Erasme Hospital Free University of Brussels
  • Saint-Luc University Hospital
  • University Hospital Brussels
  • Hvidovre Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Drug

Arm Description

FE 202158

Outcomes

Primary Outcome Measures

Percentage of Patients Maintaining Target/Adequate Mean Arterial Pressure (MAP>60 mmHg) Without Norepinephrine
Mean arterial pressure (MAP) was measured intra-arterially on a continuous basis. Success percentage of patients maintaining target/adequate MAP (>60 mmHg) without norepinephrine is presented.
Cumulative Dose of FE 202158
Cumulative dose of FE 202158 was calculated from Day 1 up to Day 7.
Infusion Rate of FE 202158
Infusion rate of FE 202158 was presented from Day 1 up to Day 7.
Cumulative Dose of Norepinephrine
Norepinephrine was infused as required to maintain the target mean arterial pressure, if the highest infusion rate allowed of experimental drug FE 202158 did not provide adequate vasopressor support. Cumulative dose of norepinephrine was calculated from Day 1 up to Day 7.
Infusion Rate of Norepinephrine
Norepinephrine was infused as required to maintain the target mean arterial pressure, if the highest infusion rate allowed of experimental drug FE 202158 did not provide adequate vasopressor support. Infusion rates and all changes in infusion rates of norepinephrine were recorded continuously during the 7 day maximum treatment period.
Time to Septic Shock Resolution
The Kaplan-Meyer estimation of time to out of septic shock was estimated where time to (first) septic shock resolution was defined as time of end of infusion regimen. Intermittent off treatment periods were regarded as part of the shock duration. Time to all but one patient out of septic shock is presented.

Secondary Outcome Measures

Urinary Output
The urinary output was recorded every 24 hours up to Day 7, or as long as the patient was in intensive care unit.
Fluid Balance
The fluid balance (accumulated input/output) was recorded in 24-hour collecting periods when the patient was in the intensive care unit and during the infusion of FE 202158.
Summary of Investigator Reported Outcomes
Investigator reported outcome on FE 202158 performance. Answers were graded on a visual analogue scale (VAS) from 0 to 10, 0 being the worst and 10 being the best outcome.
Morbidity Assessment
Percentage of all the "Days alive and out/free of" intensive care unit, hospital, dialysis, or ventilation within Day 28 were summarized. Patients dying before or at Day 28 were counted as zero.
Graded Morbidity
Collection of data on graded morbidity was performed on Day 28 in addition to the collection of data on time of stay in intensive care unit and hospital.
Mortality
Collection of data on mortality was performed on Day 28 in addition to the collection of data on time of stay in intensive care unit and hospital.
Adverse Effects on Lab Parameters, Vital Signs and Electrocardiogram
Significant changes for vital signs (blood pressure, heart rate, mean arterial pressure), electrocardiogram (ECG), and laboratory parameters (clinical chemistry, haematology, haemostasis, and urinary parameters).

Full Information

First Posted
May 11, 2012
Last Updated
February 20, 2017
Sponsor
Ferring Pharmaceuticals
search

1. Study Identification

Unique Protocol Identification Number
NCT01612676
Brief Title
Investigating FE 202158 as Potential Primary Treatment in Patients With Early Septic Shock
Official Title
An Open Label Feasibility Trial Investigating FE 202158 as Potential Primary Vasopressor Treatment in Patients With Vasodilatory Hypotension in Early Septic Shock.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2013 (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 is to investigate the potential of FE 202158 as a treatment which can stabilize blood pressure for treatment of patients in early septic shock.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Septic Shock

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Drug
Arm Type
Experimental
Arm Description
FE 202158
Intervention Type
Drug
Intervention Name(s)
FE 202158
Primary Outcome Measure Information:
Title
Percentage of Patients Maintaining Target/Adequate Mean Arterial Pressure (MAP>60 mmHg) Without Norepinephrine
Description
Mean arterial pressure (MAP) was measured intra-arterially on a continuous basis. Success percentage of patients maintaining target/adequate MAP (>60 mmHg) without norepinephrine is presented.
Time Frame
Day 1 up to Day 7 post-infusion (Data collected at Day 1 at 1, 2, 3, 4, 5, 6, 9, 12, 15, 18 and 24 h, Day 2 at 36 and 48 h, Day 3 at 72 h, Day 4 at 96 h, Day 5 at 120 h, Day 6 at 144 h, and Day 7 at 168 h). Data is presented for specific time points.
Title
Cumulative Dose of FE 202158
Description
Cumulative dose of FE 202158 was calculated from Day 1 up to Day 7.
Time Frame
Day 1 up to Day 7 post-infusion (Data collected at Day 1 at 1, 2, 3, 4, 5, 6, 9, 12, 15, 18 and 24 h, Day 2 at 36 and 48 h, Day 3 at 72 h, Day 4 at 96 h, Day 5 at 120 h, Day 6 at 144 h, and Day 7 at 168 h). Data is presented for specific time points.
Title
Infusion Rate of FE 202158
Description
Infusion rate of FE 202158 was presented from Day 1 up to Day 7.
Time Frame
Day 1 up to Day 7 post-infusion (Data collected at Day 1 at 1, 2, 3, 4, 5, 6, 9, 12, 15, 18 and 24 h, Day 2 at 36 and 48 h, Day 3 at 72 h, Day 4 at 96 h, Day 5 at 120 h, Day 6 at 144 h, and Day 7 at 168 h). Data is presented for specific time points.
Title
Cumulative Dose of Norepinephrine
Description
Norepinephrine was infused as required to maintain the target mean arterial pressure, if the highest infusion rate allowed of experimental drug FE 202158 did not provide adequate vasopressor support. Cumulative dose of norepinephrine was calculated from Day 1 up to Day 7.
Time Frame
Day 1 up to Day 7 post-infusion (Data collected at Day 1 at 1, 2, 3, 4, 5, 6, 9, 12, 15, 18 and 24 h, Day 2 at 36 and 48 h, Day 3 at 72 h, Day 4 at 96 h, Day 5 at 120 h, Day 6 at 144 h, and Day 7 at 168 h). Data is presented for specific time points.
Title
Infusion Rate of Norepinephrine
Description
Norepinephrine was infused as required to maintain the target mean arterial pressure, if the highest infusion rate allowed of experimental drug FE 202158 did not provide adequate vasopressor support. Infusion rates and all changes in infusion rates of norepinephrine were recorded continuously during the 7 day maximum treatment period.
Time Frame
Day 1 up to Day 7 post-infusion (Data collected at Day 1 at 1, 2, 3, 4, 5, 6, 9, 12, 15, 18 and 24 h, Day 2 at 36 and 48 h, Day 3 at 72 h, Day 4 at 96 h, Day 5 at 120 h, Day 6 at 144 h, and Day 7 at 168 h). Data is presented for specific time points.
Title
Time to Septic Shock Resolution
Description
The Kaplan-Meyer estimation of time to out of septic shock was estimated where time to (first) septic shock resolution was defined as time of end of infusion regimen. Intermittent off treatment periods were regarded as part of the shock duration. Time to all but one patient out of septic shock is presented.
Time Frame
Day 1 up to Day 28
Secondary Outcome Measure Information:
Title
Urinary Output
Description
The urinary output was recorded every 24 hours up to Day 7, or as long as the patient was in intensive care unit.
Time Frame
Day 1 up to Day 7 post-infusion (Data collected on Day 1 at 24 h, Day 2 at 48 h, Day 3 at 72 h, Day 4 at 96 h, Day 5 at 120 h, Day 6 at 144 h, and Day 7 at 168 h). Data is presented for specific time points.
Title
Fluid Balance
Description
The fluid balance (accumulated input/output) was recorded in 24-hour collecting periods when the patient was in the intensive care unit and during the infusion of FE 202158.
Time Frame
Day 1 up to Day 7 post-infusion (Data collected on Day 1 at 24 h, Day 2 at 48 h, Day 3 at 72 h, Day 4 at 96 h, Day 5 at 120 h, Day 6 at 144 h, and Day 7 at 168 h). Data is presented for specific time points.
Title
Summary of Investigator Reported Outcomes
Description
Investigator reported outcome on FE 202158 performance. Answers were graded on a visual analogue scale (VAS) from 0 to 10, 0 being the worst and 10 being the best outcome.
Time Frame
Day 1 up to Day 2
Title
Morbidity Assessment
Description
Percentage of all the "Days alive and out/free of" intensive care unit, hospital, dialysis, or ventilation within Day 28 were summarized. Patients dying before or at Day 28 were counted as zero.
Time Frame
Day 1 up to Day 28
Title
Graded Morbidity
Description
Collection of data on graded morbidity was performed on Day 28 in addition to the collection of data on time of stay in intensive care unit and hospital.
Time Frame
Day 1 up to Day 28
Title
Mortality
Description
Collection of data on mortality was performed on Day 28 in addition to the collection of data on time of stay in intensive care unit and hospital.
Time Frame
Day 1 up to Day 28
Title
Adverse Effects on Lab Parameters, Vital Signs and Electrocardiogram
Description
Significant changes for vital signs (blood pressure, heart rate, mean arterial pressure), electrocardiogram (ECG), and laboratory parameters (clinical chemistry, haematology, haemostasis, and urinary parameters).
Time Frame
Day 1 up to Day 7, and at follow-up assessments performed 24-72 hours after end of IMP infusion

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 women 18 years of age or older Body weight below 115 kg for male patients and 100 kg for female patients Proven or suspected infection Septic shock, i.e. vasodilatory hypotension requiring vasopressor support Willing to use an adequate barrier method or hormonal method of contraception, if not abstinent, from informed consent to one week after the end of infusion of study medication Exclusion Criteria: Present or a history within the last 6 months of symptoms of acute coronary syndrome (myocardial infarction or unstable angina) Known or suspected endocarditis 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 Known or suspected infection with (HIV)-1, HIV-2, hepatitis B, or hepatitis C Pregnancy or breastfeeding Any cause of hypotension other than early septic shock Use of vasopressin or terlipressin within 7 days prior to start of IMP infusion Proven or suspected acute mesenteric ischemia, as judged by the investigator Known episode of septic shock within 1 month prior to screening Death anticipated within 24 hours, or due to the underlying disease within 3 months Known past or current 2nd and 3rd degree AV-block without a well functioning pacemaker Brain injury within current hospitalisation Present hospitalisation with burn injury Symptomatic peripheral vascular disease including Raynaud's syndrome Previously included in this trial Intake of an Investigational Medicinal Product (IMP) 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 interventional 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
Erasme Hospital Free University of Brussels
City
Brussels
Country
Belgium
Facility Name
Saint-Luc University Hospital
City
Brussels
Country
Belgium
Facility Name
University Hospital Brussels
City
Brussels
Country
Belgium
Facility Name
Hvidovre Hospital
City
Hvidovre
Country
Denmark

12. IPD Sharing Statement

Learn more about this trial

Investigating FE 202158 as Potential Primary Treatment in Patients With Early Septic Shock

We'll reach out to this number within 24 hrs