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| Name | Class |
|---|---|
| Erasme University Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Induced hypothermia at 33°C: | Experimental |
| |
| Control normothermia | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 2 months after randomization |
| All-cause mortality 3 months after randomization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jean-Baptiste LASCARROU, PH | Contact | +33(0)240087386 | jeanbaptiste.lascarrou@chu-nantes.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Erasme | Brussels | Belgium |
|
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| 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. |
|
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) |
| 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) | 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) | 6 months after randomization |
| ICU lengths of stay | from day of randomization until the day of discharge from ICU, an average of 20 days. |
| Hospital lengths stay | 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 | 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. | 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. | 4 months after randomization |
| Mechanical ventilation duration | A score of 0 to 3 is considered a favorable neurological outcome. | from time of randomization to final extubation or up to 28 days |
| Biomarkers concentration : neuron-specific enolase (NSE) on day 0 | at day 0 |
| Biomarkers concentration : neuron-specific enolase (NSE) on day 2 | at day 2 |
| Biomarkers concentration : neuron-specific enolase (NSE) on day 3 | at day 3 |
| Biomarkers concentration : neurofilament light chain (NFL) on day 2 | at day 2 |
| Health-related quality of life (HRQoL) assessed using the 36-item Short Form Health Survey (SF-36) 6 months after randomization | 6 months after randomization |
| Cognitive dysfunction assessed using the Montreal Cognitive Assessment (MoCA) 6 months after randomization | 6 months after randomization |
| Complications during ICU stay : nosocomial infections | from day of randomization until the day of discharge from ICU, or up to 28 days. |
| Complications during ICU stay : severe arrhythmias | from day of randomization until the day of discharge from ICU, or up to 28 days. |
| Complications during ICU stay : venous thromboembolism | from day of randomization until the day of discharge from ICU, or up to 28 days. |
| Complications during ICU stay : ischemic complications | from day of randomization until the day of discharge from ICU, or up to 28 days. |
| Complications during ICU stay : sedations complications | from day of randomization until the day of discharge from ICU, or up to 28 days. |
| CHU Charleroi | Charleroi | Belgium |
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| Hôpital Universitaire de Gand | Ghent | Belgium |
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| Hôpital Universitaire de Bruxelles | Jette | Belgium |
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| Clinique Saint-PIerre | Ottignies | Belgium |
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| CH d'Angoulême | Angoulême | 16000 | France |
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| CH Dubois Brive | Brive-la-Gaillarde | 19312 cedex | France |
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| CHU de Caen | Caen | 14033 | France |
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| Hôpital Simone Veil | Cannes | 06414 cedex | France |
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| CH Public du Cotentin | Cherbourg | 50102 | France |
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| CHU Clermont-Ferrand | Clermont-Ferrand | 63003 cedex 1 | France |
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| CHU Bocage | Dijon | 77908 | France |
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| CHD Vendée | La Roche-sur-Yon | 85025 Cedex | France |
|
| Hôpital André Mignot | Le Chesnay | 78150 | France |
|
| CHRU- Hôpital Roger Salengro | Lille | 59307 cedex | France |
| CHU Dupuytren | Limoges | 87042 Cedex 1 | France |
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| Hôpital Edouard Herriot | Lyon | 69437 | France |
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| APHM - Hôpital Nord | Marseille | 13015 | France |
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| Hôpital Privé Jacques Cartier | Massy | 91300 | France |
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| CHU de Nantes | Nantes | France |
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| Hôpital de l'Archet | Nice | 06200 | France |
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| CHR d'Orléans | Orléans | 45100 | France |
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| APHP-Hôpital Saint-Antoine | Paris | 75517 | France |
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| APHP- Hôpital Cochin | Paris | 75679 cedex 14 | France |
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| APHP - Hôpital Ambroise Paré | Paris | 92200 | France |
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| CH de Roanne | Roanne | France |
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| CH de Rodez | Rodez | 12027 | France |
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| CHRU de Strasbourg | Strasbourg | 67091 cedex | France |
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| Hôpital Sainte-Musse | Toulon | 83100 | France |
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| CHRU de Tours | Tours | 37044 Cedex 9 | France |
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| CH Brocéliande Atlantique | Vannes | 56017 cedex 1 | France |
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| CHU Les Abymes | Pointe-à-Pitre | La Guadeloupe | 97110 | Guadeloupe |
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| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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