A Phase 3 interventional study of Administration of AVP and Administration of placebo AVP in Postresuscitation Syndrome, sponsored by Assistance Publique - Hôpitaux de Paris. Recruiting at 14 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-12.
Sponsored by Assistance Publique - Hôpitaux de Paris · Phase 3, Interventional, and Treatment
The primary objective is to demonstrate the superiority of arginine-vasopressin (AVP) and hydrocortisone compared with norepinephrine regarding day-30 survival and neurological recovery in post-cardiac arrest patients with hemodynamic failure.
For patients successfully resuscitated who got restoration of spontaneous circulation (ROSC) after cardiopulmonary resuscitation (CPR), the course is usually marked by a post-resuscitation syndrome including multiple organ failures of various intensity and anoxic brain damage. The cardiocirculatory failure usually dominates the clinical picture, and it often leads to multiorgan failure. This hemodynamic failure is multifactorial, including at various levels vasoplegia, myocardial dysfunction, endotoxin release and adrenal dysfunction and is at least partly related to a hormonal defect that could be counteracted by hormonal supplementation. Such a substitutive opotherapy by hydrocortisone and AVP could improve hemodynamic failure and decrease overall mortality in this setting.
This trial is a superiority multicentric trial and patients will be randomized in a 1:1:1:1 ratio using an electronic CRF.
Investigational medicinal products:
AVP will be administered according to mean arterial pressure to target a 65mmHg blood pressure for max 3 days.
Comparator treatment: placebos.
17 ICU centers in France will participate to this study targetting 380 patient's enrollment in the study.
Exclusion Criteria:
REVERPLEG® 40 IU/2mL+ Placebo of hydrocortisone.
Drug: Administration of AVP · Drug: Administration of placebo hydrocortisone
Placebo of REVERPLEG® 40 IU/2mL + Hydrocortisone 100mg UPJOHN®.
Drug: Administration of placebo AVP · Drug: Administration of hydrocortisone
REVERPLEG® 40 IU/2mL + Hydrocortisone 100mg UPJOHN®.
Drug: Administration of AVP · Drug: Administration of hydrocortisone
Placebo of REVERPLEG® 40 IU/2mL + placebo of hydrocortisone
Drug: Administration of placebo AVP · Drug: Administration of placebo hydrocortisone
Administration of AVP
Administration of placebo AVP
Administration of placebo hydrocortisone
Administration of hydrocortisone
Neurological outcome
The primary endpoint will be the good neurological outcome at day-30. This will be evaluated using the Glasgow Outcome Scale (GOS, addendum 18.5.1) dichotomized as follow: good neurological outcome for categories 4 and 5 and poor neurological outcome or death for categories 3, 2 and 1. The GOS will be obtained at day-30 from an in-hospital visit if the patient is still hospitalized or from telephone contact with patients, relatives or general practitioners.
Time frame: at day-30
All-cause mortality
Vital status at day-30.
Time frame: at day-30
Mortality attributed to irreversible hemodynamic failure
Time to irreversible cardiovascular failure defined as death in pharmacologically uncontrollable hypotension (mean arterial blood pressure \< 60 mmHg) despite maximal ICU care, or withdrawal of care based on same, as previously defined (Witten L, Resuscitation 2019).
Time frame: at day-30
Mortality attributed to neurological withdrawal of care
Time to neurological withdrawal of care. Withdrawal of care will be based on expectations of a poor neurological recovery based on most recent guidelines (Sandroni C, ICM 2015).
Time frame: at day-30
Mortality attributed to comorbid withdrawal of care
Time to comorbid withdrawal of care. Comorbid withdrawal of care or refusal of life-sustaining therapy based on the expectation of a poor quality of life. This may be related to a preexisting or newly discovered terminal illness or other serious medical condition (e.g. dementia or cancer).
Time frame: at day-30
Day-30 brain death
Time to brain death (according to French legislation)
Time frame: at day-30
mortality attributed to recurrent cardiac arrest
Time to recurrent cardiac arrest
Time frame: at day-30
Other causes
Proportion of patients dead from a cause not listed above.
Time frame: at day-30
Neurological recovery at day-30
Glasgow outcome score - extended at day-30. This score will be evaluated similarly to the primary endpoint
Time frame: at day-30
Brain damage
Neuron-specific enolase (NSE) blood level measured 48 and 72 hours after CA
Time frame: at 48 hours and at 72hours
Plan to share: No
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Assistance Publique - Hôpitaux de Paris