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

NCT07086703 | Not Yet Recruiting

• 1 other identifier: RC23_0488
• Study Type: interventional
• Target: 788
• Locations: 3 countries
• Sites: 32

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

Outcome Measures

Primary Outcomes (1)

• To assess whether induced hypothermia (TTM at 33°C) is superior to targeted normothermia in providing a favorable neurological outcome, defined as a modified Rankin Scale (mRS) score of 0 to 3 at 6 months.

  The primary endpoint is a favorable neurological outcome at 6 months, defined as an mRS score between 0 and 3.

  6 months after randomization

Secondary Outcomes (21)

• All-cause mortality 2 months after randomization

  2 months after randomization

• All-cause mortality 3 months after randomization

  3 months after randomization

• All-cause mortality 4 months after randomization

  4 months after randomization

• All-cause mortality 6 months after randomization

  6 months after randomization

• ICU lengths of stay

  from day of randomization until the day of discharge from ICU, an average of 20 days.

Study Arms (2)

Induced hypothermia at 33°C:

EXPERIMENTAL

Other: Induced hypothermia at 33°C

Control normothermia

ACTIVE COMPARATOR

Other: Control normothermia

Interventions

Induced hypothermia at 33°C 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.

Induced hypothermia at 33°C:

Control normothermia 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.

Control normothermia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Age 18 years or older
• Healthcare costs covered by the French statutory healthcare insurance system

You may not qualify if:

• 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

Sponsors & Collaborators

• Nantes University Hospital: lead
• Erasme University Hospital: collaborator

Study Sites (32)

Hôpital Erasme

Brussels, Belgium

Location

CHU Charleroi

Charleroi, Belgium

Location

Hôpital Universitaire de Gand

Ghent, Belgium

Location

Hôpital Universitaire de Bruxelles

Jette, Belgium

Location

Clinique Saint-PIerre

Ottignies, Belgium

Location

CH d'Angoulême

Angoulême, 16000, France

Location

CH Dubois Brive

Brive-la-Gaillarde, 19312 cedex, France

Location

CHU de Caen

Caen, 14033, France

Location

Hôpital Simone Veil

Cannes, 06414 cedex, France

Location

CH Public du Cotentin

Cherbourg, 50102, France

Location

CHU Clermont-Ferrand

Clermont-Ferrand, 63003 cedex 1, France

Location

CHU Bocage

Dijon, 77908, France

Location

CHD Vendée

La Roche-sur-Yon, 85025 Cedex, France

Location

Hôpital André Mignot

Le Chesnay, 78150, France

Location

CHRU- Hôpital Roger Salengro

Lille, 59307 cedex, France

Location

CHU Dupuytren

Limoges, 87042 Cedex 1, France

Location

Hôpital Edouard Herriot

Lyon, 69437, France

Location

APHM - Hôpital Nord

Marseille, 13015, France

Location

Hôpital Privé Jacques Cartier

Massy, 91300, France

Location

CHU de Nantes

Nantes, France

Location

Hôpital de l'Archet

Nice, 06200, France

Location

CHR d'Orléans

Orléans, 45100, France

Location

APHP-Hôpital Saint-Antoine

Paris, 75517, France

Location

APHP- Hôpital Cochin

Paris, 75679 cedex 14, France

Location

APHP - Hôpital Ambroise Paré

Paris, 92200, France

Location

CH de Roanne

Roanne, France

Location

CH de Rodez

Rodez, 12027, France

Location

CHRU de Strasbourg

Strasbourg, 67091 cedex, France

Location

Hôpital Sainte-Musse

Toulon, 83100, France

Location

CHRU de Tours

Tours, 37044 Cedex 9, France

Location

CH Brocéliande Atlantique

Vannes, 56017 cedex 1, France

Location

CHU Les Abymes

Pointe-à-Pitre, La Guadeloupe, 97110, Guadeloupe

Location

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Jean-Baptiste LASCARROU, PH

CONTACT

+33(0)240087386; jeanbaptiste.lascarrou@chu-nantes.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2025
• First Posted: July 25, 2025
• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): May 1, 2029
• Last Updated: January 28, 2026

Record last verified: 2026-01

Locations

FR (26); GU (1); BE (5)