Long Term Follow-up of Cardiac Arrest Survivors Exposed to Ultra-rapid Cooling

NCT07028372 | Recruiting

• 2 other identifiers: APHP2503602025-A00442-47
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 2

Brief Summary

Less than 10% of patients eliciting out-of-hospital cardiac arrest (OHCA) survive, although 30% can be resuscitated by Emergency services before admission in Intensive Care Units (ICU). The majority succumb to Post-Cardiac Arrest Syndrome (PCAS). PCAS is associated with high mortality (60-70%) and morbidity. One proposed method of preventing the neurological and cardiac consequences of PCAS is to lower the body temperature to 33°C as quickly as possible. This approach is known as therapeutic hypothermia or Targeted Temperature Management (TTM). The Vent2Cool system, developed by Orixha, is a novel approach that enables the rapid induction of therapeutic hypothermia by using hypothermic Total Liquid Ventilation (TLV) to reach a protective temperature of 33°C within minutes. The OverCool feasibility study, which started in April 2025, is designed to validate the clinical performance and safety of an ultra-rapid cooling approach combining ultra-rapid hypothermia induction using the Vent2Cool system, and maintenance and rewarming using the ArcticSun system. The AfterCool study aims to evaluate long-term outcomes during a five-year follow-up of cardiac arrest survivors who were treated with ultrarapid cooling in the OverCool study.

Conditions

Cardiac Arrest (CA); Resuscitated Sudden Cardiac Death; Post Cardiac Arrest Patient Who Was Treated by Hypothermia Protocol

Keywords

Cardiac arrest; Hypothermia; Target temperature management; Liquid ventilation; Resuscitation; long-term outcomes

Outcome Measures

Primary Outcomes (1)

• Life status at 5 years

  The primary endpoint is the life status at 5 years assessed by phone interview. Whenever possible, life status will be confirmed by reviewing the medical record.

  5 years

Secondary Outcomes (10)

• Suspected cause of death

  5 years

• Rehospitalization

  5 years

• Modified Rankin Scale (mRS) Score

  Baseline, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years

• 36-Item Short Form Health Survey (SF-36) score

  Baseline, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years

• Activity of Daily Living (ADL) score

  Baseline, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years

Study Arms (1)

Resuscitated OverCool clinical investigation participants alive at 28 days after cardiac arrest

Patients who were resuscitated after cardiac arrest, treated with ultrarapid cooling as part of the OverCool clinical investigation and survived until the end of the investigation (28 days after cardiac arrest and subsequent Vent2Cool treatment).

Other: Short Form Health Survey (SF-36); Other: Modified Rankin Score (mRS); Other: Activity of Daily Living (ADL) questionnaire; Other: New York Heart Association (NYHA) Classification; Other: St George's Respiratory Questionnaire (SGRQ)

Interventions

Short Form Health Survey (SF-36) OTHER

Heath-related quality-of-life is assessed using the SF-36 questionnaire, which is administered at the inclusion visite, then at month 6, year 1, year 2, year 3, year 4 and year 5, in the form of a telephone interview.

Resuscitated OverCool clinical investigation participants alive at 28 days after cardiac arrest

Modified Rankin Score (mRS) OTHER

The degree of disability/dependence is evaluated using the mRS scale at the inclusion visite, then at month 6, year 1, year 2, year 3, year 4 and year 5, via telephone interview.

Resuscitated OverCool clinical investigation participants alive at 28 days after cardiac arrest

Activity of Daily Living (ADL) questionnaire OTHER

Level of independence is evaluated using the ADL questionnaire, which is administered at the inclusion visite, then at month 6, year 1, year 2, year 3, year 4 and year 5, in the form of a telephone interview.

Resuscitated OverCool clinical investigation participants alive at 28 days after cardiac arrest

New York Heart Association (NYHA) Classification OTHER

The extent of heart failure is assessed using the NYHA functional classification at the inclusion visite, then at month 6, year 1, year 2, year 3, year 4 and year 5, via telephone interview.

Resuscitated OverCool clinical investigation participants alive at 28 days after cardiac arrest

St George's Respiratory Questionnaire (SGRQ) OTHER

Respiratory status is assessed using the SGRQ questionnaire at the inclusion visite, then at month 6, year 1, year 2, year 3, year 4 and year 5, via telephone interview.

Resuscitated OverCool clinical investigation participants alive at 28 days after cardiac arrest

Eligibility Criteria

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

Study Population

Cardiac arrest patient included in and alive at the end of the OverCool clinical investigation (28 days after the cardiac arrest)

You may qualify if:

• Age of 18 years and over
• Cardiac arrest patient included in and alive at the end of the OverCool clinical investigation (28 days after the cardiac arrest)
• Non-opposition from the patient or the trusted person or the close relative or parent obtained within 3 months after the end of the OverCool study

You may not qualify if:

• Follow-up refusal from patient of trusted person or the close relative or parent
• Having being included in the OverCool clinical investigation but not submitted to the Vent2Cool procedure
• Impossibility to reach the patient or the trusted person or the close relative or parent

Sponsors & Collaborators

• ORIXHA: collaborator
• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (2)

Angers University Hospital, Medical Intensive Care Unit, Vent'Lab

Angers, Alain MERCAT, France

NOT YET RECRUITING

AP-HP Centre, Cochin Hospital, Medical Intensive Care Unit

Paris, 75014, France

RECRUITING

Related Publications (17)

• Tissier R, Taccone FS, Lamhaut L, Vicaut E, Paublant F, Ricard JD, Mercat A, Cariou A. Design of the OverCool study: Lung-conservative liquid ventilation for the induction of Ultra-Rapid Cooling after Cardiac Arrest (OverCool). Resusc Plus. 2025 Mar 10;23:100926. doi: 10.1016/j.resplu.2025.100926. eCollection 2025 May.

  PMID: 40212905 BACKGROUND

• Dumas F, Paoli A, Paul M, Savary G, Jaubert P, Chocron R, Varenne O, Mira JP, Charpentier J, Bougouin W, Cariou A. Association between previous health condition and outcome after cardiac arrest. Resuscitation. 2021 Oct;167:267-273. doi: 10.1016/j.resuscitation.2021.06.017. Epub 2021 Jul 7.

  PMID: 34245838 BACKGROUND

• Bougouin W, Lascarrou JB, Chelly J, Benghanem S, Geri G, Maizel J, Fage N, Sboui G, Pichon N, Daubin C, Sauneuf B, Mongardon N, Taccone F, Hermann B, Colin G, Lesieur O, Deye N, Chudeau N, Cour M, Bourenne J, Klouche K, Klein T, Raphalen JH, Muller G, Galbois A, Bruel C, Jacquier S, Paul M, Sandroni C, Cariou A. Performance of the ERC/ESICM-recommendations for neuroprognostication after cardiac arrest: Insights from a prospective multicenter cohort. Resuscitation. 2024 Sep;202:110362. doi: 10.1016/j.resuscitation.2024.110362. Epub 2024 Aug 14.

  PMID: 39151721 BACKGROUND

• Flajoliet N, Bourenne J, Marin N, Chelly J, Lascarrou JB, Daubin C, Bougouin W, Cariou A, Geri G. Return to work after out of hospital cardiac arrest, insights from a prospective multicentric French cohort. Resuscitation. 2024 Jun;199:110225. doi: 10.1016/j.resuscitation.2024.110225. Epub 2024 Apr 27.

  PMID: 38685375 BACKGROUND

• Lascarrou JB, Merdji H, Le Gouge A, Colin G, Grillet G, Girardie P, Coupez E, Dequin PF, Cariou A, Boulain T, Brule N, Frat JP, Asfar P, Pichon N, Landais M, Plantefeve G, Quenot JP, Chakarian JC, Sirodot M, Legriel S, Letheulle J, Thevenin D, Desachy A, Delahaye A, Botoc V, Vimeux S, Martino F, Giraudeau B, Reignier J; CRICS-TRIGGERSEP Group. Targeted Temperature Management for Cardiac Arrest with Nonshockable Rhythm. N Engl J Med. 2019 Dec 12;381(24):2327-2337. doi: 10.1056/NEJMoa1906661. Epub 2019 Oct 2.

  PMID: 31577396 BACKGROUND

• Arrich J, Herkner H, Mullner D, Behringer W. Targeted temperature management after cardiac arrest. A systematic review and meta-analysis of animal studies. Resuscitation. 2021 May;162:47-55. doi: 10.1016/j.resuscitation.2021.02.002. Epub 2021 Feb 12.

  PMID: 33582259 BACKGROUND

• Kohlhauer M, Lidouren F, Remy-Jouet I, Mongardon N, Adam C, Bruneval P, Hocini H, Levy Y, Blengio F, Carli P, Vivien B, Ricard JD, Micheau P, Walti H, Nadeau M, Robert R, Richard V, Mulder P, Maresca D, Demene C, Pernot M, Tanter M, Ghaleh B, Berdeaux A, Tissier R. Hypothermic Total Liquid Ventilation Is Highly Protective Through Cerebral Hemodynamic Preservation and Sepsis-Like Mitigation After Asphyxial Cardiac Arrest. Crit Care Med. 2015 Oct;43(10):e420-30. doi: 10.1097/CCM.0000000000001160.

  PMID: 26110489 BACKGROUND

• Darbera L, Chenoune M, Lidouren F, Kohlhauer M, Adam C, Bruneval P, Ghaleh B, Dubois-Rande JL, Carli P, Vivien B, Ricard JD, Berdeaux A, Tissier R. Hypothermic liquid ventilation prevents early hemodynamic dysfunction and cardiovascular mortality after coronary artery occlusion complicated by cardiac arrest in rabbits. Crit Care Med. 2013 Dec;41(12):e457-65. doi: 10.1097/CCM.0b013e3182a63b5d.

  PMID: 24126441 BACKGROUND

• Che D, Li L, Kopil CM, Liu Z, Guo W, Neumar RW. Impact of therapeutic hypothermia onset and duration on survival, neurologic function, and neurodegeneration after cardiac arrest. Crit Care Med. 2011 Jun;39(6):1423-30. doi: 10.1097/CCM.0b013e318212020a.

  PMID: 21610611 BACKGROUND

• Dankiewicz J, Cronberg T, Lilja G, Jakobsen JC, Levin H, Ullen S, Rylander C, Wise MP, Oddo M, Cariou A, Belohlavek J, Hovdenes J, Saxena M, Kirkegaard H, Young PJ, Pelosi P, Storm C, Taccone FS, Joannidis M, Callaway C, Eastwood GM, Morgan MPG, Nordberg P, Erlinge D, Nichol AD, Chew MS, Hollenberg J, Thomas M, Bewley J, Sweet K, Grejs AM, Christensen S, Haenggi M, Levis A, Lundin A, During J, Schmidbauer S, Keeble TR, Karamasis GV, Schrag C, Faessler E, Smid O, Otahal M, Maggiorini M, Wendel Garcia PD, Jaubert P, Cole JM, Solar M, Borgquist O, Leithner C, Abed-Maillard S, Navarra L, Annborn M, Unden J, Brunetti I, Awad A, McGuigan P, Bjorkholt Olsen R, Cassina T, Vignon P, Langeland H, Lange T, Friberg H, Nielsen N; TTM2 Trial Investigators. Hypothermia versus Normothermia after Out-of-Hospital Cardiac Arrest. N Engl J Med. 2021 Jun 17;384(24):2283-2294. doi: 10.1056/NEJMoa2100591.

  PMID: 34133859 BACKGROUND

• Sandroni C, Nolan JP, Andersen LW, Bottiger BW, Cariou A, Cronberg T, Friberg H, Genbrugge C, Lilja G, Morley PT, Nikolaou N, Olasveengen TM, Skrifvars MB, Taccone FS, Soar J. ERC-ESICM guidelines on temperature control after cardiac arrest in adults. Intensive Care Med. 2022 Mar;48(3):261-269. doi: 10.1007/s00134-022-06620-5. Epub 2022 Jan 28.

  PMID: 35089409 BACKGROUND

• Boissady E, Kohlhauer M, Lidouren F, Hocini H, Lefebvre C, Chateau-Jouber S, Mongardon N, Deye N, Cariou A, Micheau P, Ghaleh B, Tissier R. Ultrafast Hypothermia Selectively Mitigates the Early Humoral Response After Cardiac Arrest. J Am Heart Assoc. 2020 Dec;9(23):e017413. doi: 10.1161/JAHA.120.017413. Epub 2020 Nov 17.

  PMID: 33198571 BACKGROUND

• Kohlhauer M, Boissady E, Lidouren F, de Rochefort L, Nadeau M, Rambaud J, Hutin A, Dubuisson RM, Guillot G, Pey P, Bruneval P, Fortin-Pellerin E, Sage M, Walti H, Cariou A, Ricard JD, Berdeaux A, Mongardon N, Ghaleh B, Micheau P, Tissier R. A new paradigm for lung-conservative total liquid ventilation. EBioMedicine. 2020 Feb;52:102365. doi: 10.1016/j.ebiom.2019.08.026. Epub 2019 Aug 22.

  PMID: 31447395 BACKGROUND

• Chenoune M, Lidouren F, Adam C, Pons S, Darbera L, Bruneval P, Ghaleh B, Zini R, Dubois-Rande JL, Carli P, Vivien B, Ricard JD, Berdeaux A, Tissier R. Ultrafast and whole-body cooling with total liquid ventilation induces favorable neurological and cardiac outcomes after cardiac arrest in rabbits. Circulation. 2011 Aug 23;124(8):901-11, 1-7. doi: 10.1161/CIRCULATIONAHA.111.039388. Epub 2011 Aug 1.

  PMID: 21810660 BACKGROUND

• Berdowski J, Berg RA, Tijssen JG, Koster RW. Global incidences of out-of-hospital cardiac arrest and survival rates: Systematic review of 67 prospective studies. Resuscitation. 2010 Nov;81(11):1479-87. doi: 10.1016/j.resuscitation.2010.08.006. Epub 2010 Sep 9.

  PMID: 20828914 BACKGROUND

• Lemiale V, Dumas F, Mongardon N, Giovanetti O, Charpentier J, Chiche JD, Carli P, Mira JP, Nolan J, Cariou A. Intensive care unit mortality after cardiac arrest: the relative contribution of shock and brain injury in a large cohort. Intensive Care Med. 2013 Nov;39(11):1972-80. doi: 10.1007/s00134-013-3043-4. Epub 2013 Aug 14.

  PMID: 23942856 BACKGROUND

• Dumas F, Bougouin W, Perier MC, Marin N, Goulenok C, Vieillard-Baron A, Diehl JL, Legriel S, Deye N, Cronier P, Ricome S, Chemouni F, Mekontso Dessap A, Beganton F, Marijon E, Jouven X, Empana JP, Cariou A. Long-term follow-up of cardiac arrest survivors: Protocol of the DESAC (Devenir des survivants d'Arrets Cardiaques) study, a French multicentric prospective cohort. Resusc Plus. 2023 Aug 31;16:100460. doi: 10.1016/j.resplu.2023.100460. eCollection 2023 Dec.

  PMID: 37693335 BACKGROUND

MeSH Terms

Conditions

Heart Arrest; Hypothermia

Interventions

Activities of Daily Living; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Alain CARIOU, MD PhD

  AP-HP, Cochin Hospital, Intensive Care and Resuscitation Department

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alain CARIOU, MD PhD

CONTACT

+33 1 58 41 25 01; alain.cariou@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2025
• First Posted: June 19, 2025
• Study Start: June 11, 2025
• Primary Completion (Estimated): December 1, 2031
• Study Completion (Estimated): December 1, 2031
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)