Clinical trial NCT02711098: IL Ancillary Study of the Therapeutic Hypothermia After Nonshockable Cardiac Arrest Trial.
Official title: InterLeukine Ancillary Study of the Therapeutic Hypothermia After Nonshockable Cardiac Arrest Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cardiac Arrest
Keywords: cardiac arrest
hypothermia
critical care
Lead sponsor: Centre Hospitalier Departemental Vendee
Sponsor class: OTHER
First posted: 2016-03-17
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Cardiac arrest is at present a major cause of mortality as well as a cause of disability for the surviving victims.In Europe, every year counts as 300,000 cardiac arrests responsible for 250,000 deaths. Thus, less than 20 % of patients discharged home with impaired quality of life associated with symptoms of tiredness, stress, anxiety. The prognosis is related to the initial cardiac rhythm present during the initiation of resuscitation. Recent progress in the improvement of mortality and neurological outcome has been achieved over the last decade thanks to the systematic implementation of a period of targeted temperature control between 32 and 34 ° C in patients who benefited from the realization of at least one electrical external shock.

There are theoretical and clinical arguments to think that achieving the same way a period of targeted temperature control between 32 and 34 ° C in patients treated for cardiac arrest with a non- shockable rhythm on arrival can also benefit from this procedure. However other arguments are against this hypothesis including an increase in the risk of infection , worsening of the patient's hemodynamic status with no benefit to him. To answer this question, we conduce a randomized multicenter study testing the potential improvement of neurological outcome through this procedure targeted temperature control between 32.5 and 33.5 ° C in these patients.

IL Ancillary Study of HYPERION Trial will determine impact on inflammatory biomarkers of two temperature target for targeted temperature management (33°C or 37°C) after cardiac arrest in non-shockable rhythm.


Eligibility criteria: Inclusion Criteria:

* Cardiac arrest in nonshockable rhythm and
* Glasgow Coma Scale score ≤8. In patients receiving sedative therapy at ICU admission, the Glasgow Coma Scale score assessed by the emergency physician just before sedative therapy initiation is used.
* Patient must be randomized in a center which participate in the ancillary study.

Exclusion Criteria:

* No-flow time \>10 min (time from collapse to initiation of external cardiac massage);
* Low-flow time \>60 min (time from initiation of external cardiac massage to return of spontaneous circulation).
* Major hemodynamic instability (defined as a continuous epinephrine or norepinephrine infusion at a flow rate \>1 μg/Kg/min)
* Time from cardiac arrest to study inclusion \>300 min
* Moribund patient
* Child C cirrhosis of the liver
* Age \<18 years
* Pregnant or breastfeeding woman
* Correctional facility inmate
* Previous inclusion in another randomized clinical trial on cardiac arrest with day-90 neurological outcome as the primary endpoint
* Patient without health insurance
* Decision by the patient or next of kin to refuse the study

Primary outcomes:
measure: Interleukine 6 level between H0 and H72
timeFrame: 72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Annecy
country: France
facility: Centre hospitalier d'Annecy
city: Clermond Ferrand
country: France
facility: Medical Intensive Care Unit
city: Dijon
country: France
facility: CHU Dijon
city: La Roche Sur Yon
country: France
facility: Medical Surgical Intensive Care Unit
city: Lens
country: France
facility: Medical Surgical Intensive Care Unit
city: Limoges
country: France
facility: Medical Surgical Intensive Care Unit
city: Montauban
country: France
facility: Medical Surgical Intensive Care Unit
city: Nantes
country: France
facility: Medical Intensive Care Unit
city: Orleans
country: France
facility: CHU Orleans
city: Poitiers
country: France
facility: Medical Intensive Care Unit
city: Rodez
country: France
facility: Medical Surgical Intensive Care Unit
city: Saint Brieuc
country: France
facility: Medical Surgical Intensive Care Unit
city: Saint Malo
country: France
facility: Medical Surgical Intensive Care Unit
city: Tours
country: France
facility: CHU Tours
Study officials:
affiliation: CHD Vendee
name: Jean-Baptiste Lascarrou, MD
role: STUDY_CHAIR
References: