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A multicenter, prospective, controlled, randomized (moderate hypothermia 33°C≤ T°C ≤34°C) during 24 hours ± 1h versus normothermia (36°C≤ T°C ≤37°C), comparative open trial will be conducted on two parallel groups of patients with cardiogenic shock treated with VA-ECMO.
The HYPO-ECMO trial will test the hypothesis that moderate hypothermia (temperature between 33°C≤ T°C ≤34°C) associated with VA-ECMO support results in a reduction in 30-day mortality in comparison with the normothermia group (36°C≤ T°C ≤37°C).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Moderate hypothermia | Experimental | Moderate hypothermia :Patients with cardiogenic shock treated with arteriovenous ECMO to a strategy of moderate hypothermia during 24 hours (Temperature at 33°C≤ T°C ≤34°C) associated with usual care |
|
| Normothermia | No Intervention | Normothermia: Patients with cardiogenic shock treated with arteriovenous ECMO to a strategy of normothermia (36°C≤ T°C ≤37°C) associated with usual care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| moderate hypothermia | Other | moderate hypothermia will be induced using the heat controller of the VA-ECMO circuit. Temperature will be maintained between 33°C≤ T°C ≤34°C during 24 hours ± 1h followed by a progressive reheating (0.2±0.1°C/h) to reach 37 °C. Temperature at 37°C ± 0.3°C will be maintained during 48 hours ± 4h after having reached 37 °C. |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause Mortality | The study objective is to determine whether early moderate hypothermia (33°C≤ T°C ≤34°C) is superior to normothermia (37°C ± 0.3°C) in patients with cardiogenic shock treated with VA-ECMO with respect to 30-day mortality | Day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality | Evaluation of the impact of moderate hypothermia on mortality during hospitalization and up to 180 days | Hour 48, Day 7, Day 60, day 180 |
| Venous Arterial ECMO duration | Evaluation of the impact of moderate hypothermia on VA-ECMO weaning time |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bruno LEVY, Pr | CHRU Nancy | Principal Investigator |
| Alain COMBES, Pr | APHP-Pitié Salpêtrière | Study Chair |
| Fabrice VANHUYSE, Dr | CHRU Nancy | Study Chair |
| Nicolas GIRERD, Pr | CHRU Nancy | Study Chair |
| Patrick ROSSIGNOL, Pr | CHRU Nancy | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Amiens - Picardie -Site sud | Amiens | France | ||||
| CH Annecy Centre Hospitalier |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40390595 | Derived | Baudry G, Girerd N, Duarte K, Monzo L, Delmas C, Van Spall HGC, Kimmoun A, Levy B. Sex-Related Prognosis of VA-ECMO-Treated Cardiogenic Shock: A Post Hoc Analysis of the HYPO-ECMO Trial. Circ Heart Fail. 2025 Aug;18(8):e012702. doi: 10.1161/CIRCHEARTFAILURE.124.012702. Epub 2025 May 20. | |
| 40023081 | Derived | Baudry G, Levy B, Duarte K, Monzo L, Combes A, Kimmoun A, Girerd N. Prognosis of refractory cardiogenic shock in de-novo versus acute-on-chronic heart failure: Insights from the HYPO-ECMO trial. J Crit Care. 2025 Jun;87:155043. doi: 10.1016/j.jcrc.2025.155043. Epub 2025 Feb 28. |
| Label | URL |
|---|---|
| Statistical analysis plan | View source |
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|
| up to 180 days (from date of randomization until ECMO weaning) |
| Death | Evaluation of the impact of moderate hypothermia on adverse cardiovascular events. Composite endpoint of death, cardiac transplant, escalation to Left Ventricular Assist Device, stroke (cf secondary outcome n° 4, 5;6;7) | day 30, Day 60, Day 180 |
| cardiac transplant | Evaluation of the impact of moderate hypothermia on adverse cardiovascular events. Composite endpoint of death, cardiac transplant, escalation to Left Ventricular Assist Device, stroke (cf secondary outcome n° 4, 5;6;7) | day 30, Day 60, Day 180 |
| escalation to Left Ventricular Assist Device | Evaluation of the impact of moderate hypothermia on adverse cardiovascular events. Composite endpoint of death, cardiac transplant, escalation to Left Ventricular Assist Device, stroke (cf secondary outcome n° 4, 5;6;7) | day 30, Day 60, Day180 |
| Stroke | Evaluation of the impact of moderate hypothermia on adverse cardiovascular events. Composite endpoint of death, cardiac transplant, escalation to Left Ventricular Assist Device, stroke (cf secondary outcome n° 4, 5;6;7) | Day 30, Day 60, Day 180 |
| Cumulated amount of administered fluids | Evaluation of the impact of moderate hypothermia on necessity of fluid | up to 180 days (from date of randomization until ECMO weaning) |
| Cumulated amount of vasopressors use | Evaluation of the impact of moderate hypothermia on necessity of vasopressor (norepinephrine, epinephrine) | up to 180 days (from date of randomization until ECMO weaning) |
| Lactate | Evaluation of the impact of moderate hypothermia on lactate clearance | up to 180 days (from date of randomization until ECMO weaning) |
| SOFA score | Evaluation of the impact of moderate hypothermia on duration of organ failure | from baseline until Day 30 |
| Mechanical ventilation | Evaluation of the impact of moderate hypothermia on mechanical ventilation support use | baseline, day 30, day 60 and day 180 |
| Renal replacement therapy | Evaluation of the impact of moderate hypothermia on renal replacement therapy use | from baseline until day 30, day 60, day 180 |
| Intensive care unit stay | Evaluation of the impact of moderate hypothermia on duration of ICU stay | Day 30; Day 60; Day 180 |
| hospitalization stay | Evaluation of the impact of moderate hypothermia on duration of total hospitalization | Day 30; Day 60; Day 180 |
| bleeding complications | Evaluation of the impact of moderate hypothermia on the risk of bleeding under ECMO | Hour 48, Day 7 |
| packed red blood cells transfused | Evaluation of the impact of moderate hypothermia on the risk of bleeding under ECMO | Hour 48, Day 7 |
| Infection | Evaluation of the impact of moderate hypothermia on risk of sepsis (pulmonary, blood, venous lines, cannulaes) | Hour 48, Day 7, Day 30, Day 60, day 180 |
| Annecy |
| France |
| CHU Besançon Hôpital Jean Minjoz | Besançon | France |
| CHU Bordeaux - Groupe Hospitalier SaintAndré | Bordeaux | France |
| CHU Clermont-Ferrand -Hopital G. Montpied | Clermont-Ferrand | France |
| CHU Grenoble | Grenoble | France |
| CHU Lyon - Hôpital Louis Pradel | Lyon | France |
| APHM-Hôpital, de la Timone | Marseille | France |
| CHU Montpellier | Montpellier | France |
| CHU Nantes/ Hôpital Nord Laennec | Nantes | France |
| APHP- Hôpital Bichat | Paris | France |
| APHP- la Pitié Sapêtrière | Paris | France |
| Aphp-Hegp | Paris | France |
| APHP-Pitié | Paris | France |
| CHU Rennes Hôpital Pontchaillou | Rennes | France |
| Chu Rouen | Rouen | France |
| CHRU Strasbourg | Strasbourg | France |
| CHU Strasbourg/ NHC | Strasbourg | France |
| CHU Toulouse Hôpital - Pierre Paul Riquet | Toulouse | France |
| CHRU Nancy | Vandœuvre-lès-Nancy | France |
| 38536534 | Derived | Levy B, Girerd N, Baudry G, Duarte K, Cuau S, Bakker J, Kimmoun A; HYPO-ECMO trial group and the International ECMO Network (ECMONet). Serial daily lactate levels association with 30-day outcome in cardiogenic shock patients treated with VA-ECMO: a post-hoc analysis of the HYPO-ECMO study. Ann Intensive Care. 2024 Mar 27;14(1):43. doi: 10.1186/s13613-024-01266-6. |
| 35103766 | Derived | Levy B, Girerd N, Amour J, Besnier E, Nesseler N, Helms J, Delmas C, Sonneville R, Guidon C, Rozec B, David H, Bougon D, Chaouch O, Walid O, Herve D, Belin N, Gaide-Chevronnay L, Rossignol P, Kimmoun A, Duarte K, Slutsky AS, Brodie D, Fellahi JL, Ouattara A, Combes A; HYPO-ECMO Trial Group and the International ECMO Network (ECMONet). Effect of Moderate Hypothermia vs Normothermia on 30-Day Mortality in Patients With Cardiogenic Shock Receiving Venoarterial Extracorporeal Membrane Oxygenation: A Randomized Clinical Trial. JAMA. 2022 Feb 1;327(5):442-453. doi: 10.1001/jama.2021.24776. |
| 31615800 | Derived | Jacquot A, Lepage X, Merckle L, Girerd N, Levy B. Protocol for a multicentre randomised controlled trial evaluating the effects of moderate hypothermia versus normothermia on mortality in patients with refractory cardiogenic shock rescued by venoarterial extracorporeal membrane oxygenation (VA-ECMO) (HYPO-ECMO study). BMJ Open. 2019 Oct 14;9(10):e031697. doi: 10.1136/bmjopen-2019-031697. |
| ID | Term |
|---|---|
| D012770 | Shock, Cardiogenic |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D012769 | Shock |
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| ID | Term |
|---|---|
| D007036 | Hypothermia, Induced |
| ID | Term |
|---|---|
| D017679 | Cryotherapy |
| D013812 | Therapeutics |
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