Targeted Temperature Management at 33°C for in-hospital cardiac arrest

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized trial compares induced hypothermia at 33°C with controlled normothermia in comatose adults who have had a resuscitated in-hospital cardiac arrest. Participants must have sustained ROSC, evidence of coma, and be enrolled within 90 minutes of ROSC, with next-of-kin consent obtained. The study seeks to determine if 33°C TTM can improve survival with favorable neurological outcome versus normothermia in the IHCA population, where data are limited. Sites include hospitals in Belgium and France, led by Nantes University Hospital with collaboration from Erasme University Hospital. The trial builds on mixed prior evidence from OHCA and IHCA subgroups regarding temperature management effects.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* IHCA (unwitnessed IHCA with initial asystole; these patients may still be eligible if visible or audible signs of life were witnessed within 10 minutes after IHCA (no-flow duration ≤10 minutes, in keeping with the non-inclusion criteria for HYPERION study).
* Sustained ROSC (Return Of Spontaneous Circulation) defined as signs of circulation for 20 minutes without chest compressions
* At least 1 mg of epinephrine
* Coma defined as an inability to obey verbal commands (Glasgow Coma Scale motor response \<6 or Full Outline of UnResponsiveness (FOUR) score motor response \<4) after sustained ROSC
* Eligible for intensive care without restrictions or limitations
* Inclusion within 90 minutes of ROSC
* Age 18 years or older
* Next of kin informed about the trial and having consented to participation of the patient in the trial (patients with coma are unable to consent). If no next of kin can be contacted during screening for the study, trial inclusion will be completed as an emergency procedure by the ICU physician, in compliance with Country of inclusion law.
* Healthcare costs covered by a healthcare insurance system

Exclusion Criteria:

* Temperature at admission \<30°C
* Obvious or suspected pregnancy
* Intracranial bleeding
* Dependent on others for activities of daily living before hospitalization
* Patient under curators, guardianship or under protection of justice
* Correctional facility inmate
* Patient who does no speak French

Where it's running

• Hôpital Universitaire de Gand
  Ghent, Belgium, Belgium Recruiting
• Hôpital Universitaire de Bruxelles
  Jette, Belgium, Belgium Recruiting
• Clinique Saint-PIerre
  Ottignies, Belgium, Belgium Recruiting
• Hôpital Erasme
  Brussels, Belgium Recruiting
• CHU Charleroi
  Charleroi, Belgium Recruiting
• CH d'Angoulême
  Angoulême, France, France Recruiting

Study contacts

• Study coordinator: Jean-Baptiste LASCARROU, PH
• Email: jeanbaptiste.lascarrou@chu-nantes.fr
• Phone: +33(0)240087386

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.