Cardiac Arrest Clinical Trials

Find Cardiac Arrest Clinical Trials Near You

Targeted Temperature Management at 33°C Versus Controlled Normothermia for In-hospital Cardiac Arrest

Status: Recruiting
Location: See all (32) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The IH-TTM trial is designed to determine whether survival with a favorable neurological outcome is improved by induced hypothermia at 33°C in comatose critically ill patients admitted after resuscitated in-hospital cardiac arrest (IHCA). Recent evidence suggests that targeted temperature management (TTM) at 33°C may provide no survival benefits compared to controlled normothermia in unselected patients with out-of-hospital cardiac arrest (OHCA). However, this evidence is relevant only to OHCA of presumed cardiac origin, chiefly witnessed and immediately followed by resuscitation efforts. Only scant data are available for cardiac arrest (CA) of other origins and for IHCA. In a randomized clinical trial of patients with CA in an initial non-shockable rhythm, the subgroup with IHCA had significantly better outcomes when treated with TTM at 33°C versus controlled normothermia; nevertheless, the sample size was limited. Another randomized controlled trial done specifically in patients with IHCA failed to show benefits of TTM at 33°C compared to controlled normothermia but was underpowered. Thus, whether therapeutic hypothermia is indicated after IHCA remains unclear. IH-TTM will be the largest trial assessing TTM after IHCA.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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 the French statutory healthcare insurance system

Locations
Other Locations
Belgium
Hôpital Erasme
RECRUITING
Brussels
CHU Charleroi
RECRUITING
Charleroi
Hôpital Universitaire de Gand
RECRUITING
Ghent
Hôpital Universitaire de Bruxelles
RECRUITING
Jette
Clinique Saint-PIerre
RECRUITING
Ottignies
France
CH d'Angoulême
RECRUITING
Angoulême
CH Dubois Brive
RECRUITING
Brive-la-gaillarde
CHU de Caen
RECRUITING
Caen
Hôpital Simone Veil
RECRUITING
Cannes
CH Public du Cotentin
RECRUITING
Cherbourg
CHU Clermont-Ferrand
RECRUITING
Clermont-ferrand
CHU Bocage
RECRUITING
Dijon
CHD Vendée
RECRUITING
La Roche-sur-yon
Hôpital André Mignot
RECRUITING
Le Chesnay
CHRU- Hôpital Roger Salengro
RECRUITING
Lille
CHU Dupuytren
RECRUITING
Limoges
Hôpital Edouard Herriot
RECRUITING
Lyon
APHM - Hôpital Nord
RECRUITING
Marseille
Hôpital Privé Jacques Cartier
RECRUITING
Massy
CHU de Nantes
RECRUITING
Nantes
Hôpital de l'Archet
RECRUITING
Nice
CHR d'Orléans
RECRUITING
Orléans
APHP - Hôpital Ambroise Paré
RECRUITING
Paris
APHP- Hôpital Cochin
RECRUITING
Paris
APHP-Hôpital Saint-Antoine
RECRUITING
Paris
CH de Roanne
RECRUITING
Roanne
CH de Rodez
RECRUITING
Rodez
CHRU de Strasbourg
RECRUITING
Strasbourg
Hôpital Sainte-Musse
RECRUITING
Toulon
CHRU de Tours
RECRUITING
Tours
CH Brocéliande Atlantique
RECRUITING
Vannes
Guadeloupe
CHU Les Abymes
RECRUITING
Pointe-à-pitre
Contact Information
Primary
Jean-Baptiste LASCARROU, PH
jeanbaptiste.lascarrou@chu-nantes.fr
+33(0)240087386
Time Frame
Start Date: 2026-08-13
Estimated Completion Date: 2029-08-13
Participants
Target number of participants: 788
Treatments
Experimental: Induced hypothermia at 33°C:
Active_comparator: Control normothermia
Related Therapeutic Areas
Sponsors
Leads: Nantes University Hospital
Collaborators: Erasme University Hospital

This content was sourced from clinicaltrials.gov