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

February 22, 2019 updated by: Centre Hospitalier Departemental Vendee

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

106

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Annecy, France
        • Medical Surgical Intensive Care Unit
      • Clermont-Ferrand, France
        • Medical Intensive Care Unit
      • Dijon, France
        • Medical 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 Surgical Intensive Care Unit
      • Nantes, France
        • Medical Intensive Care Unit
      • Orléans, France
        • Medical Surgical Intensive Care Unit
      • Poitiers, France
        • Medical Intensive Care Unit
      • Rodez, France
        • Medical Surgical Intensive Care Unit
      • Saint Brieuc, France
        • Medical Surgical Intensive Care Unit
      • Saint Malo, France
        • Medical Surgical Intensive Care Unit
      • Tours, France
        • Medical Intensive Care Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
NSE level between day 1 and day 3
Time Frame: Day 3
Day 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Departemental Vendee

Investigators

  • Study Chair: Jean-Baptiste Lascarrou, MD, CHD Vendee

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Actual)

January 14, 2018

Study Completion (Actual)

August 9, 2018

Study Registration Dates

First Submitted

March 24, 2016

First Submitted That Met QC Criteria

March 24, 2016

First Posted (Estimate)

March 30, 2016

Study Record Updates

Last Update Posted (Actual)

February 25, 2019

Last Update Submitted That Met QC Criteria

February 22, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NSE-HYPERION

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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