Effects of the V1a Agonist FE 202158 in Patients With Septic Shock
NCT ID: NCT01000649
Last Updated: 2017-09-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
53 participants
INTERVENTIONAL
2009-11-30
2011-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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FE 202158 1.25
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.
FE 202158 1.25
FE 202158 at dose 1.25 ng/kg/min infused.
FE 202158 2.5
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.
FE 202158 2.5
FE 202158 at dose 2.5 ng/kg/min infused.
FE 202158 3.75
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.
FE 202158 3.75
FE 202158 at dose 3.75 ng/kg/min infused.
PLCBO
Patients in the arm received an intravenous infusion for up to 7 days of placebo.
Placebo
Isotonic saline infused.
Interventions
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FE 202158 1.25
FE 202158 at dose 1.25 ng/kg/min infused.
FE 202158 2.5
FE 202158 at dose 2.5 ng/kg/min infused.
FE 202158 3.75
FE 202158 at dose 3.75 ng/kg/min infused.
Placebo
Isotonic saline infused.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
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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Christiana Care Health System
Newark, Delaware, United States
Baystate Medical Center
Springfield, Massachusetts, United States
Division of Education and Research SMDC Health System
Duluth, Minnesota, United States
Cooper University Hospital
Camden, New Jersey, United States
Mount Sinai School of Medicine
New York, New York, United States
Baylor College of Medicine
Houston, Texas, United States
Clinique Universitaire St-Luc
Brussels, , Belgium
Erasme Hospital (Free University of Brussels)
Brussels, , Belgium
University Hospital Vrije Universiteit
Brussels, , Belgium
Service des Soins Intensits
Dinant, , Belgium
Royal Columbian Hospital
Vancouver, , Canada
St. Paul´s Hospital
Vancouver, , Canada
Bispebjerg Hospital
Bispebjerg, , Denmark
Rigshospitalet
Copenhagen, , Denmark
Hillerød Hospital
Hillerød, , Denmark
Hvidovre Hospital
Hvidovre, , Denmark
Countries
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References
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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.
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.
Other Identifiers
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EudraCT: 2009-010798-19
Identifier Type: -
Identifier Source: secondary_id
FE 202158 CS02
Identifier Type: -
Identifier Source: org_study_id