HYdrocortisone and VAsopressin in Post-RESuscitation Syndrome - HYVAPRESS

ASSISTANCE-PUBLIQUE HOPITAUX DE PARIS (AP-HP)0 个研究点目标入组 380 人开始时间: 2020年11月9日最近更新: 2021年1月18日

适应症

试验速览

暂无简介。

•-Adult patients (>18y)
•-Cardiac arrest (in-hospital or out-of-hospital) with sustained ROSC (> 30 minutes) admitted to the ICU
•-Post-resuscitation shock defined as arterial hypotension (SAP < 90 mmHg or MAP < 65 mmHg) unresponsive to adequate fluid loading, which occurred within the first 24 hours after ROSC and requiring norepinephrine/epinephrine continuous infusion at a dose greater or equal to 0.2µg/kg/min for at least 3 hours
•-A maximal delay between the start of norepinephrine infusion and randomization of 9 hours;
•-Informed written consent of the patient or a legally authorized close relative or emergency procedure
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 190
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 190

•-Traumatic and neurological cause of cardiac arrest
•-Shock due to uncontrolled haemorrhage
•-Previously known adrenal insufficiency
•-Limitation of life-sustaining therapies
•-Ongoing treatment by any steroids, whatever the dose
•-Ongoing mechanical circulatory assistance
•-Gastrointestinal bleeding in the past 6 weeks
•-Pregnant or breastfeeding women
•-Hypersensitivity to arginin-vasopressin and to its excipients
•-Hypersensitivity to hydrocortisone and to its excipients
•-Participation in another interventional study involving human participants or being in the exclusion period at the end of a previous study involving human participants, if applicable
•-Legal protection (i.e. incompetence to provide consent, guardianship, curator or incarceration)
•-No affiliation to a social security system

发起方

ASSISTANCE-PUBLIQUE HOPITAUX DE PARIS (AP-HP)