Selepressin Evaluation Programme for Sepsis-Induced Shock - Adaptive Clinical Trial
NCT ID: NCT02508649
Last Updated: 2021-04-06
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2/PHASE3
868 participants
INTERVENTIONAL
2015-07-31
2018-02-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo
placebo
Selepressin 1
Starting dose 1.7 ng/kg/min
selepressin
Selepressin 2
Starting dose 2.5 ng/kg/min
selepressin
Selepressin 3
Starting dose 3.5 ng/kg/min
selepressin
Selepressin 4
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.
selepressin
Interventions
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selepressin
placebo
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Ferring Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Development Support
Role: STUDY_DIRECTOR
Ferring Pharmaceuticals
Locations
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Memorial Hospital
Colorado Springs, Colorado, United States
Eastern Idaho Regional Medical Center
Idaho Falls, Idaho, United States
Rush University Medical Center
Chicago, Illinois, United States
Northshore University Healthsystem Research Institute
Evanston, Illinois, United States
Stormont Vail Health Care
Topeka, Kansas, United States
Baystate Medical Center
Springfield, Massachusetts, United States
Henry Ford Hospital
Detroit, Michigan, United States
HealthPartners Speciality Clinics
Saint Paul, Minnesota, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Cooper University Hospital
Camden, New Jersey, United States
Wake Forest University School of Medicine
Winston-Salem, North Carolina, United States
Ohio State University
Columbus, Ohio, United States
Remington Davis Inc
Columbus, Ohio, United States
St Vincent Mercy Medical Center
Toledo, Ohio, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Cliniques Universitaires Saint-Luc (there may be other sites in this country)
Brussels, , Belgium
Aalborg Universitetshospital (there may be other sites in this country)
Aalborg, , Denmark
Centre Hospitalier et Universitaire de Limoges (there may be other sites in this country)
Limoges, , France
Radboud University Nijmegen Medical Centre (there may be other sites in this country)
Nijmegen, , Netherlands
Countries
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References
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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.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2014-003973-41
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
000133
Identifier Type: -
Identifier Source: org_study_id
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