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

NCT ID: NCT07086703

Last Updated: 2026-01-28

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 788 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-05-01
• Study Completion Date: 2029-05-01

Brief 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.

Conditions

Cardiac Arrest

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Induced hypothermia at 33°C:

Group Type: EXPERIMENTAL

Induced hypothermia at 33°C

Intervention Type: OTHER

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.

Control normothermia

Group Type: ACTIVE_COMPARATOR

Control normothermia

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Erasme University Hospital

OTHER

Sponsor Role: collaborator

Nantes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Countries

Belgium; France; Guadeloupe

Central Contacts

Jean-Baptiste LASCARROU, PH

Role: CONTACT

jeanbaptiste.lascarrou@chu-nantes.fr

+33(0)240087386

Facility Contacts

Fabio Silvio TACCONE, PU-PH

Role: primary

Michael PIAGNERELLI, PU-PH

Role: primary

Patrick DRUWE, PH

Role: primary

Tim BALTHAZAR, PH

Role: primary

Nicolas SERCK, PH

Role: primary

David SCNHELL, PH

Role: primary

Nicolas PICHON, PH

Role: primary

Cédric DAUBIN, PH

Role: primary

Pierre-Marie BERTRAND, PH

Role: primary

Julien CALUS, PH

Role: primary

Cécile Gosset, PH

Role: primary

Jean-Pierre QUENOT, PU-PH

Role: primary

Gwenael COLIN, PH

Role: primary

Marine PAUL, PH

Role: primary

Marine GOUDELIN, PH

Role: primary

Laurent ARGAUD, PU-PH

Role: primary

Sami HRAIECH, PH

Role: primary

Wulfran BOUGOUIN, PH

Role: primary

Jean-Baptiste LASCARROU, PH

Role: primary

Mattieu JOSWIAK, PH

Role: primary

Grégoire MULLER, PH

Role: primary

Eric MAURY, PU-PH

Role: primary

Alain CARIOU, PU-PH

Role: primary

Guillaume GERI, PU-PH

Role: primary

Jean-Charles CHAKARIAN, PH

Role: primary

Julie DELMAS, PH

Role: primary

Hamid MERDJI, PH

Role: primary

Jonathan CHELLY, PH

Role: primary

Pierre-François DEQUIN, PH

Role: primary

Agathe DELBOVE, PH

Role: primary

Frédéric MARTINO, PU-PH

Role: primary

Other Identifiers

RC23_0488

Identifier Type: -

Identifier Source: org_study_id