Efficacy of early Argipressin (arginine vasopressin) in the management of intensive care patients with norepinephrine-refractory vasoplegic shock: a multicentric randomized, double-blind placebo-controlled superiority trial : Vaso²R
- Conditions
- norepinephrine-refractory vasoplegic shock
- Registration Number
- 2024-516639-28-00
- Lead Sponsor
- Centre Hospitalier Universitaire De Dijon
- Brief Summary
To evaluate the efficacy (reduction of mortality, reduction of renal replacement therapy duration, reduction of vasopressor administration) of early Argipressin treatment (arginine vasopressin, REVERPLEG®) compared to placebo in adult patients with refractory vasoplegic shock
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised, recruitment pending
- Sex
- Not specified
- Target Recruitment
- 390
Patients aged ≥ 18 years
Vasoplegic shock: patient requiring vasopressor AND with a cardiac index ≥ 2.3/L/min/m² (measured by echocardiography, Swan-Ganz, pulse contour analysis or thermodilution) AND with hyperlactatemia > 2 mmol/l.
Refractory shock: dose of vasopressor (express as norepinephrine base equivalent) ≥ 0.25 µg/kg/min in order to maintain perfusion pressure within patient-defined targets
Early intervention: Criteria for refractory AND vasoplegic shock reached for less than 12 hours.
Informed consent obtained from the patient or, if unable to give consent, a surrogate. If the surrogate is not available, emergency consent can be considered.
Covered by French national health insurance
Vasoplegia must be primarily caused by one of the following etiologies: - Sepsis (documented or clinically suspected infection) - Post-operative vasoplegia (following cardiac or non-cardiac surgery) - Post hemorrhage - Sterile systemic inflammation (e.g., pancreatitis, burns, trauma) - Anaphylaxis - Liver failure - Other causes of vasoplegia
Patients that do not present the criteria for vasoplegic AND refractory shock at the time of inclusion anymore (resolved condition)
Patient already enrolled in an interventional trial
Decision to limit life-sustaining treatments
under legal protection
Pregnant, parturient or breastfeeding women
Ongoing vasopressin treatment
Ongoing inotrope treatment (except norepinephrine)
Ongoing acute coronary syndrome, mesenteric ischemia
Uncontrolled active bleeding
Vasoplegia due to neurogenic shock
Vasospastic disease (Raynaud's disease, systemic scleroderma, …)
Hyponatremia <120 mmol l-1
Known hypersensitivity to Argipressin or to any of the excipients of REVERPLEG®
Study & Design
- Study Type
- Not specified
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Composite score including 3 criterions ordered from most to the least important: -mortality at D30 -use of renal replacement therapy (RRT) within 30 days post-inclusion -persistance of vasopressor use within 15 days post-inclusion. The score is calculated by comparing each patient from one group to all patients from the other group in the concerned strata (stratified win-ratio analysis). Composite score including 3 criterions ordered from most to the least important: -mortality at D30 -use of renal replacement therapy (RRT) within 30 days post-inclusion -persistance of vasopressor use within 15 days post-inclusion. The score is calculated by comparing each patient from one group to all patients from the other group in the concerned strata (stratified win-ratio analysis).
- Secondary Outcome Measures
Name Time Method Efficacy objectives: comparison between experimental group and placebo group: 2.renal failure (score ≥ 2 on the kidney disease improving global outcome (KDIGO) classification) at D30 and D90 Efficacy objectives: comparison between experimental group and placebo group: 2.renal failure (score ≥ 2 on the kidney disease improving global outcome (KDIGO) classification) at D30 and D90
Efficacy objectives: comparison between experimental group and placebo group: 4.Vasoactive Inotropic Score (VIS) between day 0 (D0) and 7 (D7) Efficacy objectives: comparison between experimental group and placebo group: 4.Vasoactive Inotropic Score (VIS) between day 0 (D0) and 7 (D7)
Efficacy objectives: comparison between experimental group and placebo group: 5.Renal replacement therapy free days, vasopressor free days ventilator free days at D30 and D90 Efficacy objectives: comparison between experimental group and placebo group: 5.Renal replacement therapy free days, vasopressor free days ventilator free days at D30 and D90
Efficacy objectives: comparison between experimental group and placebo group: 6.Length of stay (days) in intensive care unit (ICU) Efficacy objectives: comparison between experimental group and placebo group: 6.Length of stay (days) in intensive care unit (ICU)
Efficacy objectives: comparison between experimental group and placebo group: 7.Length of stay (days) until discharge from hospital Efficacy objectives: comparison between experimental group and placebo group: 7.Length of stay (days) until discharge from hospital
Safety objectives: 8.Number of serious adverse events according to the MedDRA classification in both groups Safety objectives: 8.Number of serious adverse events according to the MedDRA classification in both groups
Efficacy objectives: comparison between experimental group and placebo group: 1.number of all cause deaths in ICU, at D30 and D90 Efficacy objectives: comparison between experimental group and placebo group: 1.number of all cause deaths in ICU, at D30 and D90
Efficacy objectives: comparison between experimental group and placebo group: 3.Arrhythmia requiring treatment, myocardial injury within 7 days Efficacy objectives: comparison between experimental group and placebo group: 3.Arrhythmia requiring treatment, myocardial injury within 7 days
Trial Locations
- Locations (12)
Centre Hospitalier Universitaire De Rennes
🇫🇷Rennes, France
Centre Hospitalier Universitaire De Dijon
🇫🇷Dijon, France
Centre Hospitalier Regional Et Universitaire De Brest
🇫🇷Brest, France
Centre Hospitalier Universitaire Amiens Picardie
🇫🇷Amiens Cedex 1, France
Centre Hospitalier Universitaire Rouen
🇫🇷Rouen Cedex, France
Centre Hospitalier Universitaire De Nantes
🇫🇷Saint Herblain, France
CHU Besancon
🇫🇷Besancon, France
Assistance Publique Hopitaux De Paris
🇫🇷Paris, France
Les Hopitaux Universitaires De Strasbourg
🇫🇷Strasbourg Cedex 2, France
CHRU De Nancy
🇫🇷Vandoeuvre Les Nancy, France
Scroll for more (2 remaining)Centre Hospitalier Universitaire De Rennes🇫🇷Rennes, FranceNicolas NESSELERSite contact0299284321nicolas.nesseler@chu-rennes.fr