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IL Ancillary Study of the Therapeutic Hypothermia After Nonshockable Cardiac Arrest Trial. (IL-HYPERION)

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ClinicalTrials.gov Identifier: NCT02711098
Recruitment Status : Recruiting
First Posted : March 17, 2016
Last Update Posted : July 21, 2017
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Departemental Vendee

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.


Condition or disease Intervention/treatment Phase
Cardiac Arrest Biological: Inflammatory biomarkers dosage "Hypothermia Arm" Biological: Inflammatory biomarkers dosage "Normothermia Arm" Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: InterLeukine Ancillary Study of the Therapeutic Hypothermia After Nonshockable Cardiac Arrest Trial.
Study Start Date : March 2016
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Targeted controlled temperature between 32.5 and 33.5°C
Patients will be placed in targeted temperature control between 32.5 and 33.5 ° C for 24 hours and then slowly rewarmed for targeted temperature control between 36.5 and 37.5 ° C for 24 hours.
Biological: Inflammatory biomarkers dosage "Hypothermia Arm"
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.

Placebo Comparator: Targeted controlled temperature between 36.5 and 37.5°C
Patients will be placed in targeted temperature control between 36.5 and 37.5 ° C for 48 hours.
Biological: Inflammatory biomarkers dosage "Normothermia Arm"
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 Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02711098


Contacts
Contact: Jean-Baptiste Lascarrou, MD +33251446212 jean-baptiste.lascarrou@chd-vendee.fr

Locations
France
Centre hospitalier d'Annecy Recruiting
Annecy, France, 74374
Principal Investigator: Michel Sirodot, MD         
Medical Intensive Care Unit Recruiting
Clermond Ferrand, France
Contact: Elisabeth Coupez, MD         
CHU Dijon Recruiting
Dijon, France, 21079
Principal Investigator: Jean-Pierre Quenot, MD         
Medical Surgical Intensive Care Unit Recruiting
La Roche Sur Yon, France
Contact: Jean-Baptiste Lascarrou, MD         
Medical Surgical Intensive Care Unit Recruiting
Lens, France
Contact: Didier Thevenin, MD         
Medical Surgical Intensive Care Unit Recruiting
Limoges, France
Contact: Nicolas Pichon, MD         
Medical Surgical Intensive Care Unit Recruiting
Montauban, France
Contact: Frederic Bellec, MD         
Medical Intensive Care Unit Recruiting
Nantes, France
Contact: Jean Reignier, MD, PhD         
CHU Orleans Recruiting
Orleans, France
Principal Investigator: Thierry Boulain, MD         
Medical Intensive Care Unit Recruiting
Poitiers, France
Contact: Jean-Pierre Frat, MD         
Medical Surgical Intensive Care Unit Recruiting
Rodez, France
Contact: Arnaud Delahaye, MD         
Medical Surgical Intensive Care Unit Recruiting
Saint Brieuc, France
Contact: Jerome Bousser, MD         
Medical Surgical Intensive Care Unit Recruiting
Saint Malo, France
Contact: Vlad Botoc, MD         
CHU Tours Recruiting
Tours, France
Principal Investigator: Emmanuelle Mercier, MD         
Sponsors and Collaborators
Centre Hospitalier Departemental Vendee
Investigators
Study Chair: Jean-Baptiste Lascarrou, MD CHD Vendee

Additional Information:
Responsible Party: Centre Hospitalier Departemental Vendee
ClinicalTrials.gov Identifier: NCT02711098     History of Changes
Other Study ID Numbers: IL Ancillary Study of HYPERION
First Posted: March 17, 2016    Key Record Dates
Last Update Posted: July 21, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Centre Hospitalier Departemental Vendee:
cardiac arrest
hypothermia
critical care

Additional relevant MeSH terms:
Heart Arrest
Hypothermia
Heart Diseases
Cardiovascular Diseases
Body Temperature Changes
Signs and Symptoms