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

norepinephrine-refractory vasoplegic shock

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).

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: 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: 3.Arrhythmia requiring treatment, myocardial injury within 7 days, 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: 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, Safety objectives: 8.Number of serious adverse events according to the MedDRA classification in both groups

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