Hydrocortisone and arginine vasopressin in post-resuscitation shock: the HYVAPRESS trial

Abstract

Background

Acute circulatory failure after successfull resuscitation of cardiac arrest remains challenging and multifactorial. As the main driver of early mortality after restoration of spontaneous circulation, its therapeutic management essentially relies on fluids administration and vasopressive support using noradrenaline. Data also support the potential impact of a hormonal defect in this setting. Steroids substitution as well as argini-vasopressin treatment should be evaluated in these patients.

Methods

The HYVAPRESS trial is a 2x2 factorial randomized placebo-controlled multicentric trial evaluating the effect of both hydrocortisone and arginin-vasopressin in successfully resuscitated (inhospital and out-of-hospital) cardiac arrest patients suffering an acute circulatory failure in the first 24 h after restoration of spontaneous circulation. The main outcome will be the favourable neurological outcome assessed by the Glasgow Outcome Scale (GOS). 380 patients will be included, i.e. 95 patients in each arm, allowing the detection of a 15% difference in mortality using a power of 80% and an alpha-risk of 5%.

Discussion

Assessing therapeutics in the hemodynamic failure in post −cardiac arrest patients is challenging as the mortality is very high. Besides the vasopressive support, few investigation have been led so far to improve the management of these patients. While hydrocortisone and arginin-vasopressive have been evaluated in septic shock patients, data are lacking in this very specific subgroup of patients suffering from a very high mortality. Enrollement is ongoing.

Trial registration

Clinical Trials NCT04591990, registered on 2020, October 19th.