Prehospital Non-invasive Cooling of Comatose Patients After Cardiac Arrest

NCT03829215 | Withdrawn

• 1 other identifier: 1.2
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Single centre randomized controlled two arm clinical trial of patients after out of hospital cardiac arrest with return of spontaneous circulation. The trial objective is to investigate external cooling of cardiac arrest patients after cardiac arrest with the CAERvest cooling device. After checking inclusion and exclusion criteria and immediately after return of spontaneous circulation, the CAERvest device will be filled and placed on the supine patient's chest. A recording oesophageal temperature probe will be inserted and connected to the defibrillator. Then the patient will be transported to the Emergency Department. After admission to the emergency department, an additional endovascular cooling device will be placed and the patient will be cooled to 33°C for 24 hours (starting after reaching the target temperature range of under 34°C) with the endovascular cooling device. Then the patient will be rewarmed at 0.25 °C/h. The CAERvest device will be removed, when a temperature below 34°C is reached. After rewarming, the temperature will be controlled to be below 37.5°C for until 48 hours after cardiac arrest. After this time point pyrexia (core temperature above 37.5°C) will be treated with common pharmaceutical measures. Sedation, analgesia and relaxation will be discontinued at 36.5°C. Neurologic evaluation will be started not before 72 hours after cardiac arrest with a predefined evaluation protocol. During follow up the following secondary outcomes will be recorded: Survival to hospital discharge, survival to 30 days, survival to 6 months, best neurologic function within 30 days, best neurologic function within 6 months, and quality of life at 6 months.

Conditions

Cardiac Arrest; Postresuscitation Encephalopathy

Keywords

targeted temperature management; prehospital cooling; cardiac arrest; postresuscitation encephalopathy; resuscitation; heart arrest

Outcome Measures

Primary Outcomes (1)

• Cooling rate

  Significant reduction of oesophageal temperature with the CAERvest cooling device compared to the control group at start of the endovascular cooling device, calculated as the difference in core temperature at start of second cooling device and initial core temperature by time.

  4 hours

Secondary Outcomes (9)

• Earlier achievement of target temperature

  4 hours

• Ease of use and operator experience with the cooling device

  4 hours

• Survival to hospital discharge

  14 days

• Survival to 30 days

  30 days

• Survival to 6 months

  6 months

Other Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events

  14 days

Study Arms (2)

CAERVest cooling device

EXPERIMENTAL

After checking inclusion and exclusion criteria and immediately after return of spontaneous circulation, the CAERvest device will be filled and placed on the supine patient's chest. A recording esophageal temperature probe will be inserted and connected to the defibrillator. Then the patient will be transported to the Emergency Department. After admission to the emergency department, an additional endovascular cooling device will be placed and the patient will be cooled to 33°C for 24 hours with the endovascular cooling device. The CAERvest device will be removed, when a temperature below 34°C is reached. Then the patient will be rewarmed at 0.25 °C/h. After rewarming, the temperature will be controlled to be below 37.5°C for until 48 hours after cardiac arrest.

Device: CAERVest cooling device

Control

NO INTERVENTION

After checking inclusion and exclusion criteria and immediately after return of spontaneous circulation, a recording esophageal temperature probe will be inserted and connected to the defibrillator. Then the patient will be transported to the Emergency Department. After admission to the emergency department, an endovascular cooling device will be placed and the patient will be cooled to 33°C for 24 hours with the endovascular cooling device. Then the patient will be rewarmed at 0.25 °C/h. After rewarming, the temperature will be controlled to be below 37.5°C for until 48 hours after cardiac arrest.

Interventions

CAERVest cooling device DEVICE

The CAERVest device will be filled and placed on the supine patient's chest immediately after return of spontaneous circulation. After admission to the emergency department, the device will be removed, when a temperature below 34°C is reached.

CAERVest cooling device

Eligibility Criteria

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

You may qualify if:

• Over 18 years of age
• Witnessed cardiac arrest
• Restoration of spontaneous circulation
• All Primary rhythms
• Cardiac arrest of presumed cardiac origin

You may not qualify if:

• Hypothermia (\< 34 °C) on screening
• Comatose prior to cardiac arrest due to central nervous system depressant drugs
• CPC higher than 2 prior to cardiac arrest
• Known pregnancy
• Glasgow coma scale (GCS) \> 8 at screening
• Known malignancy e.g. terminal illness (pre-cardiac arrest life expectancy of \< 6 months due to underlying medical conditions or pre-existing co-morbidities.)
• Follow up unlikely to be possible
• Patients already randomized to a clinical trial
• The patient has a known history of bleeding diathesis, coagulopathy, cryoglobulinemia, sickle cell anaemia, or will refuse blood transfusions
• The patient is a vulnerable subject, for instance, a person in detention (i.e., prisoner or ward of the state)

Sponsors & Collaborators

• Medical University of Vienna: lead
• Bodychillz Ltd: collaborator

Study Sites (1)

Medical University of Vienna

Vienna, Vienna, 1090, Austria

Location

Related Publications (13)

• Kamarainen A, Virkkunen I, Tenhunen J, Yli-Hankala A, Silfvast T. Prehospital therapeutic hypothermia for comatose survivors of cardiac arrest: a randomized controlled trial. Acta Anaesthesiol Scand. 2009 Aug;53(7):900-7. doi: 10.1111/j.1399-6576.2009.02015.x. Epub 2009 Jun 3.

  PMID: 19496762 BACKGROUND

• Hypothermia after Cardiac Arrest Study Group. Mild therapeutic hypothermia to improve the neurologic outcome after cardiac arrest. N Engl J Med. 2002 Feb 21;346(8):549-56. doi: 10.1056/NEJMoa012689.

  PMID: 11856793 BACKGROUND

• Holzer M, Bernard SA, Hachimi-Idrissi S, Roine RO, Sterz F, Mullner M; Collaborative Group on Induced Hypothermia for Neuroprotection After Cardiac Arrest. Hypothermia for neuroprotection after cardiac arrest: systematic review and individual patient data meta-analysis. Crit Care Med. 2005 Feb;33(2):414-8. doi: 10.1097/01.ccm.0000153410.87750.53.

  PMID: 15699847 BACKGROUND

• Uray T, Mayr FB, Stratil P, Aschauer S, Testori C, Sterz F, Haugk M. Prehospital surface cooling is safe and can reduce time to target temperature after cardiac arrest. Resuscitation. 2015 Feb;87:51-6. doi: 10.1016/j.resuscitation.2014.10.026. Epub 2014 Nov 28.

  PMID: 25447355 BACKGROUND

• Nielsen N, Wetterslev J, Cronberg T, Erlinge D, Gasche Y, Hassager C, Horn J, Hovdenes J, Kjaergaard J, Kuiper M, Pellis T, Stammet P, Wanscher M, Wise MP, Aneman A, Al-Subaie N, Boesgaard S, Bro-Jeppesen J, Brunetti I, Bugge JF, Hingston CD, Juffermans NP, Koopmans M, Kober L, Langorgen J, Lilja G, Moller JE, Rundgren M, Rylander C, Smid O, Werer C, Winkel P, Friberg H; TTM Trial Investigators. Targeted temperature management at 33 degrees C versus 36 degrees C after cardiac arrest. N Engl J Med. 2013 Dec 5;369(23):2197-206. doi: 10.1056/NEJMoa1310519. Epub 2013 Nov 17.

  PMID: 24237006 BACKGROUND

• Arrich J, Holzer M, Havel C, Mullner M, Herkner H. Hypothermia for neuroprotection in adults after cardiopulmonary resuscitation. Cochrane Database Syst Rev. 2016 Feb 15;2(2):CD004128. doi: 10.1002/14651858.CD004128.pub4.

  PMID: 26878327 BACKGROUND

• Uray T, Malzer R; Vienna Hypothermia After Cardiac Arrest (HACA) Study Group. Out-of-hospital surface cooling to induce mild hypothermia in human cardiac arrest: a feasibility trial. Resuscitation. 2008 Jun;77(3):331-8. doi: 10.1016/j.resuscitation.2008.01.005. Epub 2008 Mar 7.

  PMID: 18314248 BACKGROUND

• Kim F, Olsufka M, Longstreth WT Jr, Maynard C, Carlbom D, Deem S, Kudenchuk P, Copass MK, Cobb LA. Pilot randomized clinical trial of prehospital induction of mild hypothermia in out-of-hospital cardiac arrest patients with a rapid infusion of 4 degrees C normal saline. Circulation. 2007 Jun 19;115(24):3064-70. doi: 10.1161/CIRCULATIONAHA.106.655480. Epub 2007 Jun 4.

  PMID: 17548731 BACKGROUND

• Bernard SA, Smith K, Cameron P, Masci K, Taylor DM, Cooper DJ, Kelly AM, Silvester W; Rapid Infusion of Cold Hartmanns Investigators. Induction of prehospital therapeutic hypothermia after resuscitation from nonventricular fibrillation cardiac arrest*. Crit Care Med. 2012 Mar;40(3):747-53. doi: 10.1097/CCM.0b013e3182377038.

  PMID: 22020244 BACKGROUND

• Kim F, Nichol G, Maynard C, Hallstrom A, Kudenchuk PJ, Rea T, Copass MK, Carlbom D, Deem S, Longstreth WT Jr, Olsufka M, Cobb LA. Effect of prehospital induction of mild hypothermia on survival and neurological status among adults with cardiac arrest: a randomized clinical trial. JAMA. 2014 Jan 1;311(1):45-52. doi: 10.1001/jama.2013.282173.

  PMID: 24240712 BACKGROUND

• Bernard SA, Smith K, Cameron P, Masci K, Taylor DM, Cooper DJ, Kelly AM, Silvester W; Rapid Infusion of Cold Hartmanns (RICH) Investigators. Induction of therapeutic hypothermia by paramedics after resuscitation from out-of-hospital ventricular fibrillation cardiac arrest: a randomized controlled trial. Circulation. 2010 Aug 17;122(7):737-42. doi: 10.1161/CIRCULATIONAHA.109.906859. Epub 2010 Aug 2.

  PMID: 20679551 BACKGROUND

• Kamarainen A, Virkkunen I, Tenhunen J, Yli-Hankala A, Silfvast T. Induction of therapeutic hypothermia during prehospital CPR using ice-cold intravenous fluid. Resuscitation. 2008 Nov;79(2):205-11. doi: 10.1016/j.resuscitation.2008.07.003. Epub 2008 Sep 21.

  PMID: 18809236 BACKGROUND

• Arrich J, Holzer M, Havel C, Warenits AM, Herkner H. Pre-hospital versus in-hospital initiation of cooling for survival and neuroprotection after out-of-hospital cardiac arrest. Cochrane Database Syst Rev. 2016 Mar 15;3(3):CD010570. doi: 10.1002/14651858.CD010570.pub2.

  PMID: 26978162 BACKGROUND

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Michael Holzer, M.D.

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Patient will be comatose on inclusion. Outcome assessor will not be aware of group assignment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: Single centre randomized controlled two arm clinical trial

Study Record Dates

• First Submitted: January 28, 2019
• First Posted: February 4, 2019
• Study Start: February 1, 2022
• Primary Completion: June 1, 2022
• Study Completion: December 1, 2022
• Last Updated: May 8, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)