N/A
Completed N=50
Impact of Speed Of Rewarming After CaRdiac Arrest and ThErapeutic Hypothermia
Heart Arrest · Cardiac Arrest · Hypothermia
Source: ClinicalTrials.gov NCT02555254 ↗
Enrolled (actual)
50
Serious AEs
—
Results posted
May 2025
Primary outcomePrimary: Changes in Serum Il6 Levels Over the 48 Hours Following Achievement of the Thermal Target — 12389; 8859 pg/mL*h — p=0.55
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in Serum Il6 Levels Over the 48 Hours Following Achievement of the Thermal Target |
12389; 8859 | 0.55 |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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).
- Time between cardiac arrest and more than 480 minutes inclusion
- 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
- Inclusion in advance a research protocol with the draw, and whose primary endpoint is on interleukin-6.
- Lack of social security.
- Refusal of the trusted person or patient.
Data sourced from ClinicalTrials.gov (NCT02555254). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.