2024-516639-28-00招募中3 期
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
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 390
- 试验地点
- 12
- 主要终点
- 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).
研究概览
简要总结
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
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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®
结局指标
主要结局
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).
次要结局
- 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
研究者
Chef de projets recherche
Scientific
Centre Hospitalier Universitaire De Dijon
研究点 (12)
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