Impact of Speed Of Rewarming After CaRdiac Arrest and ThErapeutic Hypothermia

NCT02555254 | Completed Results

• 1 other identifier: CHD 013-15
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

Comparing the production of interleukin 6 (inflammatory cytokine) in two heating speed (slow rewarming rate: 0.25 ° C / h or fast rewarming rate 0.50 ° C / h) at the completion of a period of targeted temperature at 33°C after cardiac arrest supported by shockable rhythm and successfully resuscitated.

Conditions

Heart Arrest; Cardiac Arrest; Hypothermia

Keywords

cardiac arrest; targeted temperature management; hypothermia induced; shockable rhythm

Outcome Measures

Primary Outcomes (1)

• Changes in Serum Il6 Levels Over the 48 Hours Following Achievement of the Thermal Target

  Median AUC for serum IL6 levels over time

  48 hours

Study Arms (2)

Low speed of rewarming

EXPERIMENTAL

Patients will be placed in targeted temperature controlled at 33°C for 24 hours. Then, intervention will be proceeded after randomization: slowly rewarmed (0.25°C/h) to targeted temperature controlled at 37°C for 24 hours.

Procedure: Low Speed of Rewarming

Fast speed of rewarming

EXPERIMENTAL

Patients will be placed in targeted temperature controlled at 33°C for 24 hours. hen, intervention will be proceeded after randomization: fastly rewarmed (0.50°C/h) for targeted temperature controlled at 37°C for 24 hours.

Procedure: High Speed of Rewarming

Interventions

Low Speed of Rewarming PROCEDURE

Speed of rewarming will be at 0.25°C/h with specific temperature controlled external device

Low speed of rewarming

High Speed of Rewarming PROCEDURE

Speed of rewarming will be at 0.50°C/h with specific temperature controlled external device

Fast speed of rewarming

Eligibility Criteria

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

You may qualify if:

• Patient has been supported for a shockable cardiac arrest with successful resuscitation.
• Coma persistent at ICU admission (Glasgow score less than or equal to 8) in the absence of sedation. If the patient is sedated in ICU admission, the glasgow score will be held the last evaluated by the doctor who provided the pre-hospital care of the patient score.
• Body temperature\> 33 ° C
• Specific device used to targeted temperature management at 33°C

You may not qualify if:

• Lack of witness of cardiac arrest.
• Duration of no-flow\> 10 minutes (time between the onset of cardiac arrest and the start of external cardiac massage).
• Duration of low-flow\> 60 minutes (the period between the start of external cardiac massage and recovery of an effective cardiac activity).
• Major hemodynamic instability (dose norepinephrine and / or epinephrine \> 1 µg / kg / min to maintain MAP\> 65 mmHg).
• Moribund.
• Presence of histologically confirmed cirrhosis of Child class C.
• Patient treatment in blocking the production of Il6 (Ro-tocilizumab or Actemra ®)
• Patient under corticosteroid treatment (dose\> 5 mg of prednisolone equivalent)
• Pregnant woman, parturient or lactating.
• Inpatient without consent and / or deprived of liberty by a court decision.
• Patient under guardianship
• Lack of social security.
• Refusal of the trusted person or patient.

Sponsors & Collaborators

• Centre Hospitalier Departemental Vendee: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator
• University Hospital, Tours: collaborator

Study Sites (1)

Colin Gwenhael

La Roche-sur-Yon, 85000, France

Location

Related Publications (2)

• Pouplet C, Colin G, Guichard E, Reignier J, Le Gouge A, Martin S, Lacherade JC, Lascarrou JB; AfterROSC network. The accuracy of various neuro-prognostication algorithms and the added value of neurofilament light chain dosage for patients resuscitated from shockable cardiac arrest: An ancillary analysis of the ISOCRATE study. Resuscitation. 2022 Feb;171:1-7. doi: 10.1016/j.resuscitation.2021.12.009. Epub 2021 Dec 13.

  PMID: 34915084 BACKGROUND

• Lascarrou JB, Guichard E, Reignier J, Le Gouge A, Pouplet C, Martin S, Lacherade JC, Colin G; AfterROSC network. Impact of rewarming rate on interleukin-6 levels in patients with shockable cardiac arrest receiving targeted temperature management at 33 degrees C: the ISOCRATE pilot randomized controlled trial. Crit Care. 2021 Dec 17;25(1):434. doi: 10.1186/s13054-021-03842-9.

  PMID: 34920723 RESULT

MeSH Terms

Conditions

Heart Arrest; Hypothermia

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Jean-Baptiste Lascarrou
• Organization: CHU Nantes

jeanbaptiste.lascarrou@chu-nantes.fr

+33251446572

Study Officials

• Jean Baptiste Lascarrou, MD

  Nantes University Hospital

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2015
• First Posted: September 21, 2015
• Study Start: February 12, 2016
• Primary Completion: May 17, 2020
• Study Completion: June 8, 2020
• Last Updated: December 2, 2025
• Results First Posted: May 22, 2025

Record last verified: 2025-11

Locations

FR (1)