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NOT YET RECRUITING
NCT07086703
NA

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

Sponsor: Nantes University Hospital

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

788

Start Date

2026-05-01

Completion Date

2029-05-01

Last Updated

2026-01-28

Healthy Volunteers

No

Conditions

Interventions

OTHER

Induced hypothermia at 33°C

Cooling and maintenance phase : The aim is to achieve the target temperature of 33±0.5°C within 60 minutes after randomization. The target temperature of 33±0.5°C and device setting of 33°C will be maintained until 28 hours after randomization. \- Rewarming: Normothermia will be restored by gradual rewarming at a rate of 0.2°C/h. \- After rewarming: After 40 hours, in those participants who are still comatose or sedated, normothermia (36.5-37.7°C) will be maintained until 72 hours after randomization, and active warming will be avoided.

OTHER

Control normothermia

Participants whose initial temperature is below 33°C may be actively rewarmed to 36.5°-37.7°C, at which point active rewarming will be stopped and passive rewarming performed according to the latest guidelines. Participants whose initial temperature is above 33°C will not be actively rewarmed to normothermia. The goal will be to maintain temperature no higher than 37.8°C. After 40 hours, in those participants who are still comatose or sedated, normothermia (36.5-37.7°C) will be maintained until 72 hours after randomization, and active warming will be avoided.

Locations (32)

Hôpital Erasme

Brussels, Belgium

CHU Charleroi

Charleroi, Belgium

Hôpital Universitaire de Gand

Ghent, Belgium

Hôpital Universitaire de Bruxelles

Jette, Belgium

Clinique Saint-PIerre

Ottignies, Belgium

CH d'Angoulême

Angoulême, France

CH Dubois Brive

Brive-la-Gaillarde, France

CHU de Caen

Caen, France

Hôpital Simone Veil

Cannes, France

CH Public du Cotentin

Cherbourg, France

CHU Clermont-Ferrand

Clermont-Ferrand, France

CHU Bocage

Dijon, France

CHD Vendée

La Roche-sur-Yon, France

Hôpital André Mignot

Le Chesnay, France

CHRU- Hôpital Roger Salengro

Lille, France

CHU Dupuytren

Limoges, France

Hôpital Edouard Herriot

Lyon, France

APHM - Hôpital Nord

Marseille, France

Hôpital Privé Jacques Cartier

Massy, France

CHU de Nantes

Nantes, France

Hôpital de l'Archet

Nice, France

CHR d'Orléans

Orléans, France

APHP-Hôpital Saint-Antoine

Paris, France

APHP- Hôpital Cochin

Paris, France

APHP - Hôpital Ambroise Paré

Paris, France

CH de Roanne

Roanne, France

CH de Rodez

Rodez, France

CHRU de Strasbourg

Strasbourg, France

Hôpital Sainte-Musse

Toulon, France

CHRU de Tours

Tours, France

CH Brocéliande Atlantique

Vannes, France

CHU Les Abymes

Pointe-à-Pitre, La Guadeloupe, Guadeloupe