Cardiac ArrestIH-TTMNCT07086703
Targeted Temperature Management at 33°C Versus Controlled Normothermia for In-hospital Cardiac Arrest
A study testing Induced hypothermia at 33°C in people with Cardiac Arrest, run by Nantes University Hospital at 31 sites in 3 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest
- What is being tested?
- Induced hypothermia at 33°C
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 788 participants
- Where
- 31 sitesin 3 countries
- Study dates
- 13 Aug 2026to 13 Aug 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- 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
Who cannot join
- 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
Trial locations and contacts
31 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
31 sites in 3 countries
France25 sites, 25 recruiting
- Recruiting
CH d'Angoulême
Angoulême, France, 16000
Laurent LAINE, PH
- Recruiting
CH Dubois Brive
Brive-la-Gaillarde, France, 19312 cedex
Nicolas PICHON, PH
- Recruiting
CHU de Caen
Caen, France, 14033
Cédric DAUBIN, PH
- Recruiting
Hôpital Simone Veil
Cannes, France, 06414 cedex
Pierre-Marie BERTRAND, PH
- Recruiting
CH Public du Cotentin
Cherbourg, France, 50102
Julien CALUS, PH
- Recruiting
CHU Clermont-Ferrand
Clermont-Ferrand, France, 63003 cedex 1
Cécile Gosset, PH
- Recruiting
CHU Bocage
Dijon, France, 77908
Jean-Pierre QUENOT, PU-PH
- Recruiting
CHD Vendée
La Roche-sur-Yon, France, 85025 Cedex
Gwenael COLIN, PH
- Recruiting
Hôpital André Mignot
Le Chesnay, France, 78150
Marine PAUL, PH
- Recruiting
CHRU- Hôpital Roger Salengro
Lille, France, 59307 cedex
Patrick GIRARDIE, PU-PH
- Recruiting
CHU Dupuytren
Limoges, France, 87042 Cedex 1
Bruno EVRARD, PH
- Recruiting
Hôpital Edouard Herriot
Lyon, France, 69437
Laurent ARGAUD, PU-PH
- Recruiting
APHM - Hôpital Nord
Marseille, France, 13015
Sami HRAIECH, PH
- Recruiting
Hôpital Privé Jacques Cartier
Massy, France, 91300
Wulfran BOUGOUIN, PH
- Recruiting
CHU de Nantes
Nantes, France
Jean-Baptiste LASCARROU, PH
- Recruiting
Hôpital de l'Archet
Nice, France, 06200
Mattieu JOZWIAK, PH
- Recruiting
CHR d'Orléans
Orléans, France, 45100
Grégoire MULLER, PH
- Recruiting
APHP-Hôpital Saint-Antoine
Paris, France, 75517
Eric MAURY, PU-PH
- Recruiting
APHP- Hôpital Cochin
Paris, France, 75679 cedex 14
Alain CARIOU, PU-PH
- Recruiting
APHP - Hôpital Ambroise Paré
Paris, France, 92200
Guillaume GERI, PU-PH
- Recruiting
CH de Roanne
Roanne, France
Jean-Charles CHAKARIAN, PH
- Recruiting
CHRU de Strasbourg
Strasbourg, France, 67091 cedex
Hamid MERDJI, PH
- Recruiting
Hôpital Sainte-Musse
Toulon, France, 83100
Jonathan CHELLY, PH
- Recruiting
CHRU de Tours
Tours, France, 37044 Cedex 9
Pierre-François DEQUIN, PH
- Recruiting
CH Brocéliande Atlantique
Vannes, France, 56017 cedex 1
Agathe DELBOVE, PH
Belgium5 sites, 5 recruiting
- Recruiting
Hôpital Erasme
Brussels
Fabio Silvio TACCONE, PU-PH
- Recruiting
CHU Charleroi
Charleroi
Michael PIAGNERELLI, PU-PH
- Recruiting
Hôpital Universitaire de Gand
Ghent, Belgium
Patrick DRUWE, PH
- Recruiting
Hôpital Universitaire de Bruxelles
Jette, Belgium
Tim BALTHAZAR, PH
- Recruiting
Clinique Saint-PIerre
Ottignies, Belgium
Nicolas SERCK, PH
Guadeloupe1 site, 1 recruiting
- Recruiting
CHU Les Abymes
Pointe-à-Pitre, La Guadeloupe, 97110
Frédéric MARTINO, PU-PH
About this study
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
- Being tested
- Induced hypothermia at 33°C, Control normothermia
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Induced hypothermia at 33°COther
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 normothermiaOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Induced hypothermia at 33°C | Experimental | Not described Receives: Other: Induced hypothermia at 33°C |
| Control normothermia | Active comparator | Not described Receives: Other: Control normothermia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months after randomization
Secondary outcomes (21)
All-cause mortality 2 months after randomization
Causes of death (refractory hemodynamic shock, life-support withdrawal for neurological reasons, life-support withdrawal due to comorbidities, respiratory failure, sudden cardiac death, brain death)
Measured: 2 months after randomization
All-cause mortality 3 months after randomization
Causes of death (refractory hemodynamic shock, life-support withdrawal for neurological reasons, life-support withdrawal due to comorbidities, respiratory failure, sudden cardiac death, brain death)
Measured: 3 months after randomization
All-cause mortality 4 months after randomization
Causes of death (refractory hemodynamic shock, life-support withdrawal for neurological reasons, life-support withdrawal due to comorbidities, respiratory failure, sudden cardiac death, brain death)
Measured: 4 months after randomization
All-cause mortality 6 months after randomization
Causes of death (refractory hemodynamic shock, life-support withdrawal for neurological reasons, life-support withdrawal due to comorbidities, respiratory failure, sudden cardiac death, brain death)
Measured: 6 months after randomization
ICU lengths of stay
Measured: from day of randomization until the day of discharge from ICU, an average of 20 days.
Hospital lengths stay
Measured: from day of randomization until the day of discharge from hospital, an average of 20 days.
Neurological outcome measured by modified Rankin Scale (mRS) score, ranging from 0 to 6 at 2 months after randomization
Measured: 2 months after randomization
Neurological outcome measured by modified Rankin Scale (mRS) score, ranging from 0 to 6 at 3 months after randomization
A score of 0 to 3 is considered a favorable neurological outcome.
Measured: 3 months after randomization
Neurological outcome measured by modified Rankin Scale (mRS) score ranging from 0 to 6 at 4 months after randomization
A score of 0 to 3 is considered a favorable neurological outcome.
Measured: 4 months after randomization
Mechanical ventilation duration
A score of 0 to 3 is considered a favorable neurological outcome.
Measured: from time of randomization to final extubation or up to 28 days
Biomarkers concentration : neuron-specific enolase (NSE) on day 0
Measured: at day 0
Biomarkers concentration : neuron-specific enolase (NSE) on day 2
Measured: at day 2
Biomarkers concentration : neuron-specific enolase (NSE) on day 3
Measured: at day 3
Biomarkers concentration : neurofilament light chain (NFL) on day 2
Measured: at day 2
Health-related quality of life (HRQoL) assessed using the 36-item Short Form Health Survey (SF-36) 6 months after randomization
Measured: 6 months after randomization
Cognitive dysfunction assessed using the Montreal Cognitive Assessment (MoCA) 6 months after randomization
Measured: 6 months after randomization
Complications during ICU stay : nosocomial infections
Measured: from day of randomization until the day of discharge from ICU, or up to 28 days.
Complications during ICU stay : severe arrhythmias
Measured: from day of randomization until the day of discharge from ICU, or up to 28 days.
Complications during ICU stay : venous thromboembolism
Measured: from day of randomization until the day of discharge from ICU, or up to 28 days.
Complications during ICU stay : ischemic complications
Measured: from day of randomization until the day of discharge from ICU, or up to 28 days.
Complications during ICU stay : sedations complications
Measured: from day of randomization until the day of discharge from ICU, or up to 28 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2025
- Study start13 Aug 2026
- Primary completion13 Aug 2029 (estimated)
- Study completion13 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 788 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Erasme University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07086703
- Sponsor's protocol ID
- RC23_0488
- Acronym
- IH-TTM
- Status last verified
- Sep 2026
- First submitted
- 18 Jul 2025
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeted Temperature Management at 33°C Versus Controlled Normothermia for In-hospital Cardiac Arrest
- ClinicalTrials.gov ID
- NCT07086703
- Acronym / sponsor ID
- IH-TTM / RC23_0488
- Conditions
- Cardiac Arrest
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 788 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Collaborators
- Erasme University Hospital
- Study start
- 13 Aug 2026 (actual)
- Primary completion
- 13 Aug 2029 (estimated)
- Study completion
- 13 Aug 2029 (estimated)
- First posted
- 25 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Induced hypothermia at 33°C | Experimental | Other: Induced hypothermia at 33°C |
| Control normothermia | Active comparator | Other: Control normothermia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Induced hypothermia at 33°CCooling 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 | Induced hypothermia at 33°C |
| Control normothermiaParticipants 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. | Other | Control normothermia |
Primary outcome
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.
Time frame: 6 months after randomization
The primary endpoint is a favorable neurological outcome at 6 months, defined as an mRS score between 0 and 3.
21 secondary outcomes
All-cause mortality 2 months after randomization
Time frame: 2 months after randomization
All-cause mortality 3 months after randomization
Time frame: 3 months after randomization
All-cause mortality 4 months after randomization
Time frame: 4 months after randomization
All-cause mortality 6 months after randomization
Time frame: 6 months after randomization
ICU lengths of stay
Time frame: from day of randomization until the day of discharge from ICU, an average of 20 days.
Hospital lengths stay
Time frame: from day of randomization until the day of discharge from hospital, an average of 20 days.
Neurological outcome measured by modified Rankin Scale (mRS) score, ranging from 0 to 6 at 2 months after randomization
Time frame: 2 months after randomization
Neurological outcome measured by modified Rankin Scale (mRS) score, ranging from 0 to 6 at 3 months after randomization
Time frame: 3 months after randomization
Neurological outcome measured by modified Rankin Scale (mRS) score ranging from 0 to 6 at 4 months after randomization
Time frame: 4 months after randomization
Mechanical ventilation duration
Time frame: from time of randomization to final extubation or up to 28 days
Biomarkers concentration : neuron-specific enolase (NSE) on day 0
Time frame: at day 0
Biomarkers concentration : neuron-specific enolase (NSE) on day 2
Time frame: at day 2
Biomarkers concentration : neuron-specific enolase (NSE) on day 3
Time frame: at day 3
Biomarkers concentration : neurofilament light chain (NFL) on day 2
Time frame: at day 2
Health-related quality of life (HRQoL) assessed using the 36-item Short Form Health Survey (SF-36) 6 months after randomization
Time frame: 6 months after randomization
Cognitive dysfunction assessed using the Montreal Cognitive Assessment (MoCA) 6 months after randomization
Time frame: 6 months after randomization
Complications during ICU stay : nosocomial infections
Time frame: from day of randomization until the day of discharge from ICU, or up to 28 days.
Complications during ICU stay : severe arrhythmias
Time frame: from day of randomization until the day of discharge from ICU, or up to 28 days.
Complications during ICU stay : venous thromboembolism
Time frame: from day of randomization until the day of discharge from ICU, or up to 28 days.
Complications during ICU stay : ischemic complications
Time frame: from day of randomization until the day of discharge from ICU, or up to 28 days.
Complications during ICU stay : sedations complications
Time frame: from day of randomization until the day of discharge from ICU, or up to 28 days.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
31 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Induced hypothermia at 33°C in people with Cardiac Arrest, run by Nantes University Hospital at 31 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in France, Belgium, Guadeloupe. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jean-Baptiste LASCARROU, PH (+33(0)240087386, jeanbaptiste.lascarrou@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 6 months after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.