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NSE Ancillary Study of The Therapeutic Hypothermia After Nonshockable Cardiac Arrest Trial. (NSE-HYPERION)

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ClinicalTrials.gov Identifier: NCT02722473
Recruitment Status : Completed
First Posted : March 30, 2016
Last Update Posted : February 25, 2019
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.

NSE-Ancillary Study of HYPERION Trial will determine impact on neurospecific enolase (brain biomarker) 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 Hypothermia Critical Care Biological: NSE dosage "hypothermia arm" Biological: NSE dosage "normothermia arm" Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 106 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: NSE Ancillary Study of The Therapeutic Hypothermia After Nonshockable Cardiac Arrest Trial.
Study Start Date : March 2016
Actual Primary Completion Date : January 14, 2018
Actual Study Completion Date : August 9, 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: NSE dosage "hypothermia arm"
There 3 dosage of NSE per patient included: day 1, day 2 and day 3 during targeted temperature management between 33° 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: NSE dosage "normothermia arm"
There 3 dosage of NSE per patient included: day 1, day 2 and day 3 during targeted temperature management at 37°C.




Primary Outcome Measures :
  1. NSE level between day 1 and day 3 [ Time Frame: Day 3 ]


Information from the National Library of Medicine

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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): NCT02722473


Locations
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France
Medical Surgical Intensive Care Unit
Annecy, France
Medical Intensive Care Unit
Clermont-Ferrand, France
Medical Intensive Care Unit
Dijon, France
Medical Surgical Intensive Care Unit
La Roche Sur Yon, France
Medical Surgical Intensive Care Unit
Lens, France
Medical Surgical Intensive Care Unit
Limoges, France
Medical Surgical Intensive Care Unit
Montauban, France
Medical Intensive Care Unit
Nantes, France
Medical Surgical Intensive Care Unit
Orléans, France
Medical Intensive Care Unit
Poitiers, France
Medical Surgical Intensive Care Unit
Rodez, France
Medical Surgical Intensive Care Unit
Saint Brieuc, France
Medical Surgical Intensive Care Unit
Saint Malo, France
Medical Intensive Care Unit
Tours, France
Sponsors and Collaborators
Centre Hospitalier Departemental Vendee
Investigators
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Study Chair: Jean-Baptiste Lascarrou, MD CHD Vendee

Additional Information:
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Responsible Party: Centre Hospitalier Departemental Vendee
ClinicalTrials.gov Identifier: NCT02722473     History of Changes
Other Study ID Numbers: NSE-HYPERION
First Posted: March 30, 2016    Key Record Dates
Last Update Posted: February 25, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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