IL Ancillary Study of the Therapeutic Hypothermia After Nonshockable Cardiac Arrest Trial.

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.

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Key information

Conditions

Cardiac Arrest Body Temperature Changes Cardiovascular Diseases Heart Arrest Heart Diseases Hypothermia Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Centre hospitalier d'Annecy, Annecy, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Inflammatory biomarkers dosage "Hypothermia Arm"

Biological

There is 6 dosage of inflammatory biomarker per patient included: H0, H12, H24, H36, H48 and H72 during targeted temperature management between 33°C and 37°C.

Inflammatory biomarkers dosage "Normothermia Arm"

Biological

There is 6 dosage of inflammatory biomarker per patient included: H0, H12, H24, H36, H48 and H72 during targeted temperature management at 37°C.

Primary outcomes

Interleukine 6 level between H0 and H72

Time frame: 72 hours

Comparing the production of interleukin 6 (inflammatory cytokine) during targeted temperature management at 33 or 37 °C after cardiac arrest in non-shockable rhythm when help arrived and before the injection of adrenaline. The analysis of the primary endpoint will be performed using an analysis of covariance, taking into account the basal value of interleukine 6. Necessary data will be pre-processed.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Departemental Vendee

Other

Registry information

Official study title

InterLeukine Ancillary Study of the Therapeutic Hypothermia After Nonshockable Cardiac Arrest Trial.

Acronym: IL-HYPERION

Important dates

Study start: 2016
Primary completion: 2018
Study completion: 2018
First posted: Mar 17, 2016
Registry last updated: Feb 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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