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Selepressin Evaluation Programme for Sepsis-Induced Shock - Adaptive Clinical Trial (SEPSIS-ACT)

Primary Purpose

Septic Shock

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
selepressin
placebo
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:

  • 18 years of age or older
  • Proven or suspected infection
  • Septic shock defined as hypotension requiring vasopressor treatment despite adequate fluid resuscitation
  • Informed consent obtained in accordance with local regulations

Exclusion Criteria:

  • Not possible to initiate trial drug treatment within 12 hours from onset of vasopressor treatment for septic shock
  • Primary cause of hypotension not due to sepsis
  • Previous severe sepsis with intensive care unit admission within this hospital stay
  • Known/suspected acute mesenteric ischaemia
  • Suspicion of concomitant acute coronary syndrome based on clinical symptoms and/or ECG during this episode of septic shock
  • Chronic mechanical ventilation for any reason OR severe chronic obstructive pulmonary disease (COPD) requiring either continuous daily oxygen use during the preceding 30 days or mechanical ventilation (for acute exacerbation of COPD) during the preceding 30 days
  • Received bone marrow transplant during the preceding 6 months or chemotherapy during the preceding 30 days for lymphoma or leukemia
  • Known to be pregnant
  • Decision to limit full care taken before obtaining informed consent
  • Use of vasopressin in the past 12 hours prior to start of trial drug treatment or use of terlipressin within 7 days prior to start of trial drug treatment
  • Prior enrolment in the trial
  • Prior use of an investigational medicinal product within the last month OR planned or concurrent participation in a clinical trial for any investigational drug or investigational device

Sites / Locations

  • Memorial Hospital
  • Eastern Idaho Regional Medical Center
  • Rush University Medical Center
  • Northshore University Healthsystem Research Institute
  • Stormont Vail Health Care
  • Baystate Medical Center
  • Henry Ford Hospital
  • HealthPartners Speciality Clinics
  • University of Nebraska Medical Center
  • Cooper University Hospital
  • Wake Forest University School of Medicine
  • Ohio State University
  • Remington Davis Inc
  • St Vincent Mercy Medical Center
  • University of Oklahoma Health Sciences Center
  • Temple University Hospital
  • University of Pittsburgh Medical Center
  • Cliniques Universitaires Saint-Luc (there may be other sites in this country)
  • Aalborg Universitetshospital (there may be other sites in this country)
  • Centre Hospitalier et Universitaire de Limoges (there may be other sites in this country)
  • Radboud University Nijmegen Medical Centre (there may be other sites in this country)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Experimental

Arm Label

Placebo

Selepressin 1

Selepressin 2

Selepressin 3

Selepressin 4

Arm Description

Starting dose 1.7 ng/kg/min

Starting dose 2.5 ng/kg/min

Starting dose 3.5 ng/kg/min

Starting dose 5.0 ng/kg/min The highest dosing regimen of selepressin was not investigated in the trial as the desired primary outcome for selepressin 3 arm was not achieved, and the trial was terminated for futility.

Outcomes

Primary Outcome Measures

Vasopressor- and Mechanical Ventilator-free Days (PVFDs)
Composite endpoint defined as number of days from start of treatment to 30 days thereafter during which subject is: Alive. However, if patient dies within these 30-days then PVFDs will be zero even if there is a period during which subject is alive and free of both vasopressor treatment and mechanical ventilation; Free of treatment with vasopressors: Less than 60 min during any contiguous 24-h period. If a patient requires vasopressors longer than 60 min in total during any 24-h period, the intervening intervals during which they are free of vasopressors will not be included in the determination of PVFDs; Free of any mechanical ventilation: Less than 60 min during any contiguous 24-h period. If a patient requires mechanical ventilation longer than 60 min in total during any 24-h period, the intervening intervals during which they are not receiving mechanical ventilation will not be included in the period free of mechanical ventilation in the determination of PVFDs.

Secondary Outcome Measures

All-cause Mortality
All-cause mortality defined as the percentage of subjects that have died, regardless of cause.
Renal Replacement Therapy (RRT)-Free Days
RRT-free days was defined as the number of days a subject is free of treatment with any form of RRT (continuous RRT, intermittent hemodialysis or peritoneal dialysis) and the intermittent periods were not included. RRT-free days was analyzed excluding subjects on RRT for chronic renal failure at time of randomization.
Intensive Care Unit (ICU)-Free Days
The ICU free days, as for the PVFDs, reflect the time from last discharge of the ICU to Day 30 with an absolute penalty for mortality, i.e., any subject that died within this 30-day period was assigned zero value).
Vasopressor-free Days up to Day 30
Number of days from start of treatment to 30 days thereafter during which the subject is free of treatment with vasopressors, i.e. less than 60 min during any contiguous 24-h period.
Mechanical Ventilator-free Days up to Day 30
Number of days from start of treatment to 30 days thereafter during which the subject is free of any mechanical ventilation, i.e. less than 60 min during any contiguous 24-h period.
Duration of Septic Shock (i.e. Vasopressor Use) up to Day 30
The duration of septic shock was defined as the cumulative periods (>1 h), from start of investigational medicinal product (IMP) treatment until Day 30, on IMP or vasopressors.
Duration of Mechanical Ventilation up to Day 30
The duration of mechanical ventilation was defined as the cumulative periods (>1 h), from start of the IMP treatment until Day 30, on mechanical ventilation.
The Percentage of Subjects With RRT up to Day 30 (Counting Subjects Who Died as on RRT and Excluding Subjects on RRT for Chronic Renal Failure at the Time of Randomization)
Renal replacement therapy is defined as continuous RRT, intermittent hemodialysis, or peritoneal dialysis. In order to ensure that any reduction in the incidence of RRT was not caused by an increase in mortality, all subjects dying within the 30-day period were counted as on RRT.
Duration of RRT up to Day 90 (Excluding Subjects on RRT for Chronic Failure at the Time of Randomization)
The duration of RRT was defined as the cumulative periods (>1 h) from start of IMP until Day 90 with RRT (continuous renal replacement therapy, intermittent hemodialysis, or peritoneal dialysis). Subjects on RRT for chronic renal failure at time of randomization were not included in the analysis.
Overall and Individual Organ (Cardiovascular, Respiratory, Renal, Hepatic, Coagulation) Scores Using a Modified Version of the SOFA up to Day 7 or Until ICU Discharge
The presence of 5 organ dysfunctions (cardiovascular, respiratory, renal, hepatic, coagulation) was assessed using a modified Sequential Organ Failure Assessment (SOFA) (i.e. SOFA except the Glasgow Coma Scale). In addition, any dose of vasopressors or positive ionotropes will attribute 3 or 2 points on the cardiovascular scale, respectively. Each organ has a possible dysfunction score of 0 (no organ dysfunction) to 4 (dysfunctional organ), for a total modified SOFA score range of 0 (no organ dysfunction) to 23 (all organs with dysfunction).
Percentage of Subjects With New Organ Dysfunction and New Organ Failure (Based on the SOFA Score) up to Day 7 and Day 30
The presence of 5 organ dysfunctions (cardiovascular, respiratory, renal, hepatic, coagulation) was assessed using a SOFA score. Each organ has a possible dysfunction score of 0 (no organ dysfunction) to 4 (all organs with dysfunction). Incidence of new organ dysfunction is defined as an increase ≥ 1 from baseline to post baseline up until the end of the period (e.g. going from 1-2) in any of the individual SOFA scores. Incidence of new organ failures is defined as a change in any of the individual SOFA scores from (0-2) at baseline to (3-4) post baseline up until the end of the period (Day 7 or 30) (if the SOFA scores goes from (0-2) to (3-4) and back to (0-2) again within the period, that will still count as a new organ failure). Percentage of subjects with new organ dysfunction and new organ failure (based on the SOFA Score) up to Day 7 and Day 30 are reported.
ICU Length of Stay up to Day 30
ICU length of stay is defined as the cumulative periods (>1 h) spent in ICU from start of IMP to 30 days after.
All-cause Mortality (Defined as the Percentage of Subjects That Have Died, Regardless of Cause) at Day 30 and Day 180
All-cause mortality defined as the percentage of subjects that have died, regardless of cause.
Daily Fluid Balance Until ICU Discharge (for a Maximum of 7 Days)
Fluid balance (as a rate of time) calculated for fluid administered during episode of severe sepsis/septic shock will be presented until ICU discharge (for a maximum of 7 days).
Cumulative Fluid Balance Until ICU Discharge (for a Maximum of 7 Days)
Cumulative fluid balance (total volume) calculated for fluid administered during episode of severe sepsis/septic shock will be presented until ICU discharge (for a maximum of 7 days).
Daily Urine Output Until ICU Discharge (for a Maximum of 7 Days)
Cumulative Urine Output Until ICU Discharge (for a Maximum of 7 Days)
Cumulative urinary output (absolute values) will be presented until ICU discharge (for a maximum of 7 Days).
Utility, Based on the EuroQol Group's 5-dimension 5-level (EQ-5D-5L) Questionnaire, up to Day 180
The EuroQoL-5-Dimensions (EQ-5D™) was used to assess the overall health of each subject. EQ-5D™ is a standardised instrument for use as a measure of health outcome. The first part of the instrument includes 5 dimensions where the subject indicates which of the given statements best describes the health state on the day of questionnaire completion. The second part contains a visual analogue scale (VAS) where the subject indicates how good or bad his or her own health is on the day of questionnaire completion. EQ-5D-5L will be analyzed by the index value (Range: 0-1; 0=dead state, 1=full health state), the overall quality-adjusted life year (QALY), and the VAS score (Range: 0-100; 0=worst health state, 100=best health state). The EQ-5D-5L was completed at baseline and at the scheduled follow-up days (i.e. Day 30, Day 60, Day 90, and Day 180). Data for EQ VAS score and EQ-5D-5L index score are reported in this endpoint.
Utility, Based on the EuroQol Group's 5-dimension 5-level (EQ-5D-5L) Questionnaire, up to Day 180
The EQ-5D™ was used to assess the overall health of each subject. EQ-5D™ is a standardised instrument for use as a measure of health outcome. The first part of the instrument includes 5 dimensions where the subject indicates which of the given statements best describes the health state on the day of questionnaire completion. The second part contains a VAS where the subject indicates how good or bad his or her own health is on the day of questionnaire completion. EQ-5D-5L will be analyzed by the index value (Range: 0-1; 0=dead state, 1=full health state), the overall QALY, and the VAS score (Range: 0-100; 0=worst health state, 100=best health state). The EQ-5D-5L was completed at baseline and at the scheduled follow-up days (i.e. Day 30, Day 60, Day 90, and Day 180). Data for EQ-5D-5L QALY is reported in this endpoint.

Full Information

First Posted
July 17, 2015
Last Updated
March 11, 2021
Sponsor
Ferring Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT02508649
Brief Title
Selepressin Evaluation Programme for Sepsis-Induced Shock - Adaptive Clinical Trial
Acronym
SEPSIS-ACT
Official Title
A Double-blind, Randomised, Placebo-Controlled, Phase 2b/3 Adaptive Clinical Trial Investigating the Efficacy and Safety of Selepressin as Treatment for Patients With Vasopressor-dependent Septic Shock
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Terminated
Why Stopped
Terminated due to futility
Study Start Date
July 2015 (Actual)
Primary Completion Date
October 3, 2017 (Actual)
Study Completion Date
February 26, 2018 (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
This is a double-blind, randomised, placebo-controlled, two-part adaptive clinical trial. The trial is designed to investigate the efficacy and safety of multiple dosing regimens of selepressin and to confirm the efficacy and safety of one dosing regimen in treatment of adult patients with septic shock requiring vasopressor.

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, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
868 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Selepressin 1
Arm Type
Experimental
Arm Description
Starting dose 1.7 ng/kg/min
Arm Title
Selepressin 2
Arm Type
Experimental
Arm Description
Starting dose 2.5 ng/kg/min
Arm Title
Selepressin 3
Arm Type
Experimental
Arm Description
Starting dose 3.5 ng/kg/min
Arm Title
Selepressin 4
Arm Type
Experimental
Arm Description
Starting dose 5.0 ng/kg/min The highest dosing regimen of selepressin was not investigated in the trial as the desired primary outcome for selepressin 3 arm was not achieved, and the trial was terminated for futility.
Intervention Type
Drug
Intervention Name(s)
selepressin
Intervention Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
Vasopressor- and Mechanical Ventilator-free Days (PVFDs)
Description
Composite endpoint defined as number of days from start of treatment to 30 days thereafter during which subject is: Alive. However, if patient dies within these 30-days then PVFDs will be zero even if there is a period during which subject is alive and free of both vasopressor treatment and mechanical ventilation; Free of treatment with vasopressors: Less than 60 min during any contiguous 24-h period. If a patient requires vasopressors longer than 60 min in total during any 24-h period, the intervening intervals during which they are free of vasopressors will not be included in the determination of PVFDs; Free of any mechanical ventilation: Less than 60 min during any contiguous 24-h period. If a patient requires mechanical ventilation longer than 60 min in total during any 24-h period, the intervening intervals during which they are not receiving mechanical ventilation will not be included in the period free of mechanical ventilation in the determination of PVFDs.
Time Frame
Up to Day 30
Secondary Outcome Measure Information:
Title
All-cause Mortality
Description
All-cause mortality defined as the percentage of subjects that have died, regardless of cause.
Time Frame
At Day 90
Title
Renal Replacement Therapy (RRT)-Free Days
Description
RRT-free days was defined as the number of days a subject is free of treatment with any form of RRT (continuous RRT, intermittent hemodialysis or peritoneal dialysis) and the intermittent periods were not included. RRT-free days was analyzed excluding subjects on RRT for chronic renal failure at time of randomization.
Time Frame
Up to Day 30
Title
Intensive Care Unit (ICU)-Free Days
Description
The ICU free days, as for the PVFDs, reflect the time from last discharge of the ICU to Day 30 with an absolute penalty for mortality, i.e., any subject that died within this 30-day period was assigned zero value).
Time Frame
Up to Day 30
Title
Vasopressor-free Days up to Day 30
Description
Number of days from start of treatment to 30 days thereafter during which the subject is free of treatment with vasopressors, i.e. less than 60 min during any contiguous 24-h period.
Time Frame
Up to Day 30
Title
Mechanical Ventilator-free Days up to Day 30
Description
Number of days from start of treatment to 30 days thereafter during which the subject is free of any mechanical ventilation, i.e. less than 60 min during any contiguous 24-h period.
Time Frame
Up to Day 30
Title
Duration of Septic Shock (i.e. Vasopressor Use) up to Day 30
Description
The duration of septic shock was defined as the cumulative periods (>1 h), from start of investigational medicinal product (IMP) treatment until Day 30, on IMP or vasopressors.
Time Frame
Up to Day 30
Title
Duration of Mechanical Ventilation up to Day 30
Description
The duration of mechanical ventilation was defined as the cumulative periods (>1 h), from start of the IMP treatment until Day 30, on mechanical ventilation.
Time Frame
Up to Day 30
Title
The Percentage of Subjects With RRT up to Day 30 (Counting Subjects Who Died as on RRT and Excluding Subjects on RRT for Chronic Renal Failure at the Time of Randomization)
Description
Renal replacement therapy is defined as continuous RRT, intermittent hemodialysis, or peritoneal dialysis. In order to ensure that any reduction in the incidence of RRT was not caused by an increase in mortality, all subjects dying within the 30-day period were counted as on RRT.
Time Frame
Up to Day 30
Title
Duration of RRT up to Day 90 (Excluding Subjects on RRT for Chronic Failure at the Time of Randomization)
Description
The duration of RRT was defined as the cumulative periods (>1 h) from start of IMP until Day 90 with RRT (continuous renal replacement therapy, intermittent hemodialysis, or peritoneal dialysis). Subjects on RRT for chronic renal failure at time of randomization were not included in the analysis.
Time Frame
Up to Day 90
Title
Overall and Individual Organ (Cardiovascular, Respiratory, Renal, Hepatic, Coagulation) Scores Using a Modified Version of the SOFA up to Day 7 or Until ICU Discharge
Description
The presence of 5 organ dysfunctions (cardiovascular, respiratory, renal, hepatic, coagulation) was assessed using a modified Sequential Organ Failure Assessment (SOFA) (i.e. SOFA except the Glasgow Coma Scale). In addition, any dose of vasopressors or positive ionotropes will attribute 3 or 2 points on the cardiovascular scale, respectively. Each organ has a possible dysfunction score of 0 (no organ dysfunction) to 4 (dysfunctional organ), for a total modified SOFA score range of 0 (no organ dysfunction) to 23 (all organs with dysfunction).
Time Frame
Days 1, 3, and 7 or discharge from ICU
Title
Percentage of Subjects With New Organ Dysfunction and New Organ Failure (Based on the SOFA Score) up to Day 7 and Day 30
Description
The presence of 5 organ dysfunctions (cardiovascular, respiratory, renal, hepatic, coagulation) was assessed using a SOFA score. Each organ has a possible dysfunction score of 0 (no organ dysfunction) to 4 (all organs with dysfunction). Incidence of new organ dysfunction is defined as an increase ≥ 1 from baseline to post baseline up until the end of the period (e.g. going from 1-2) in any of the individual SOFA scores. Incidence of new organ failures is defined as a change in any of the individual SOFA scores from (0-2) at baseline to (3-4) post baseline up until the end of the period (Day 7 or 30) (if the SOFA scores goes from (0-2) to (3-4) and back to (0-2) again within the period, that will still count as a new organ failure). Percentage of subjects with new organ dysfunction and new organ failure (based on the SOFA Score) up to Day 7 and Day 30 are reported.
Time Frame
Up to Day 7 and Day 30
Title
ICU Length of Stay up to Day 30
Description
ICU length of stay is defined as the cumulative periods (>1 h) spent in ICU from start of IMP to 30 days after.
Time Frame
Up to Day 30
Title
All-cause Mortality (Defined as the Percentage of Subjects That Have Died, Regardless of Cause) at Day 30 and Day 180
Description
All-cause mortality defined as the percentage of subjects that have died, regardless of cause.
Time Frame
At Day 30 and Day 180
Title
Daily Fluid Balance Until ICU Discharge (for a Maximum of 7 Days)
Description
Fluid balance (as a rate of time) calculated for fluid administered during episode of severe sepsis/septic shock will be presented until ICU discharge (for a maximum of 7 days).
Time Frame
Baseline and Days 1-7
Title
Cumulative Fluid Balance Until ICU Discharge (for a Maximum of 7 Days)
Description
Cumulative fluid balance (total volume) calculated for fluid administered during episode of severe sepsis/septic shock will be presented until ICU discharge (for a maximum of 7 days).
Time Frame
Baseline and Days 1-7
Title
Daily Urine Output Until ICU Discharge (for a Maximum of 7 Days)
Time Frame
Baseline and Days 1-7
Title
Cumulative Urine Output Until ICU Discharge (for a Maximum of 7 Days)
Description
Cumulative urinary output (absolute values) will be presented until ICU discharge (for a maximum of 7 Days).
Time Frame
Baseline and Days 1-7
Title
Utility, Based on the EuroQol Group's 5-dimension 5-level (EQ-5D-5L) Questionnaire, up to Day 180
Description
The EuroQoL-5-Dimensions (EQ-5D™) was used to assess the overall health of each subject. EQ-5D™ is a standardised instrument for use as a measure of health outcome. The first part of the instrument includes 5 dimensions where the subject indicates which of the given statements best describes the health state on the day of questionnaire completion. The second part contains a visual analogue scale (VAS) where the subject indicates how good or bad his or her own health is on the day of questionnaire completion. EQ-5D-5L will be analyzed by the index value (Range: 0-1; 0=dead state, 1=full health state), the overall quality-adjusted life year (QALY), and the VAS score (Range: 0-100; 0=worst health state, 100=best health state). The EQ-5D-5L was completed at baseline and at the scheduled follow-up days (i.e. Day 30, Day 60, Day 90, and Day 180). Data for EQ VAS score and EQ-5D-5L index score are reported in this endpoint.
Time Frame
Baseline and Days 30, 60, 90 and 180
Title
Utility, Based on the EuroQol Group's 5-dimension 5-level (EQ-5D-5L) Questionnaire, up to Day 180
Description
The EQ-5D™ was used to assess the overall health of each subject. EQ-5D™ is a standardised instrument for use as a measure of health outcome. The first part of the instrument includes 5 dimensions where the subject indicates which of the given statements best describes the health state on the day of questionnaire completion. The second part contains a VAS where the subject indicates how good or bad his or her own health is on the day of questionnaire completion. EQ-5D-5L will be analyzed by the index value (Range: 0-1; 0=dead state, 1=full health state), the overall QALY, and the VAS score (Range: 0-100; 0=worst health state, 100=best health state). The EQ-5D-5L was completed at baseline and at the scheduled follow-up days (i.e. Day 30, Day 60, Day 90, and Day 180). Data for EQ-5D-5L QALY is reported in this endpoint.
Time Frame
Days 30, 60, 90 and 180

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years of age or older Proven or suspected infection Septic shock defined as hypotension requiring vasopressor treatment despite adequate fluid resuscitation Informed consent obtained in accordance with local regulations Exclusion Criteria: Not possible to initiate trial drug treatment within 12 hours from onset of vasopressor treatment for septic shock Primary cause of hypotension not due to sepsis Previous severe sepsis with intensive care unit admission within this hospital stay Known/suspected acute mesenteric ischaemia Suspicion of concomitant acute coronary syndrome based on clinical symptoms and/or ECG during this episode of septic shock Chronic mechanical ventilation for any reason OR severe chronic obstructive pulmonary disease (COPD) requiring either continuous daily oxygen use during the preceding 30 days or mechanical ventilation (for acute exacerbation of COPD) during the preceding 30 days Received bone marrow transplant during the preceding 6 months or chemotherapy during the preceding 30 days for lymphoma or leukemia Known to be pregnant Decision to limit full care taken before obtaining informed consent Use of vasopressin in the past 12 hours prior to start of trial drug treatment or use of terlipressin within 7 days prior to start of trial drug treatment Prior enrolment in the trial Prior use of an investigational medicinal product within the last month OR planned or concurrent participation in a clinical trial for any investigational drug or investigational device
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
Memorial Hospital
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
Country
United States
Facility Name
Eastern Idaho Regional Medical Center
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Northshore University Healthsystem Research Institute
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
Stormont Vail Health Care
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66604
Country
United States
Facility Name
Baystate Medical Center
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01199
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
Country
United States
Facility Name
HealthPartners Speciality Clinics
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55101
Country
United States
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Facility Name
Cooper University Hospital
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Facility Name
Wake Forest University School of Medicine
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210-1252
Country
United States
Facility Name
Remington Davis Inc
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Facility Name
St Vincent Mercy Medical Center
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43608
Country
United States
Facility Name
University of Oklahoma Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
Temple University Hospital
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
Facility Name
Cliniques Universitaires Saint-Luc (there may be other sites in this country)
City
Brussels
Country
Belgium
Facility Name
Aalborg Universitetshospital (there may be other sites in this country)
City
Aalborg
Country
Denmark
Facility Name
Centre Hospitalier et Universitaire de Limoges (there may be other sites in this country)
City
Limoges
Country
France
Facility Name
Radboud University Nijmegen Medical Centre (there may be other sites in this country)
City
Nijmegen
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
31577035
Citation
Laterre PF, Berry SM, Blemings A, Carlsen JE, Francois B, Graves T, Jacobsen K, Lewis RJ, Opal SM, Perner A, Pickkers P, Russell JA, Windelov NA, Yealy DM, Asfar P, Bestle MH, Muller G, Bruel C, Brule N, Decruyenaere J, Dive AM, Dugernier T, Krell K, Lefrant JY, Megarbane B, Mercier E, Mira JP, Quenot JP, Rasmussen BS, Thorsen-Meyer HC, Vander Laenen M, Vang ML, Vignon P, Vinatier I, Wichmann S, Wittebole X, Kjolbye AL, Angus DC; SEPSIS-ACT Investigators. Effect of Selepressin vs Placebo on Ventilator- and Vasopressor-Free Days in Patients With Septic Shock: The SEPSIS-ACT Randomized Clinical Trial. JAMA. 2019 Oct 15;322(15):1476-1485. doi: 10.1001/jama.2019.14607. Erratum In: JAMA. 2019 Nov 12;322(18):1830.
Results Reference
derived
PubMed Identifier
29388815
Citation
Lewis RJ, Angus DC, Laterre PF, Kjolbye AL, van der Meulen E, Blemings A, Graves T, Russell JA, Carlsen JE, Jacobsen K, Yealy DM, Opal SM, Windelov NA, Francois B, Perner A, Pickkers P, Berry SM. Rationale and Design of an Adaptive Phase 2b/3 Clinical Trial of Selepressin for Adults in Septic Shock. Selepressin Evaluation Programme for Sepsis-induced Shock-Adaptive Clinical Trial. Ann Am Thorac Soc. 2018 Feb;15(2):250-257. doi: 10.1513/AnnalsATS.201708-669SD.
Results Reference
derived

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Selepressin Evaluation Programme for Sepsis-Induced Shock - Adaptive Clinical Trial

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