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NSE Ancillary Study of The Therapeutic Hypothermia After Nonshockable Cardiac Arrest Trial.

NCT02722473 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2019-02-25

No results posted yet for this study

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.

Conditions

  • Cardiac Arrest
  • Hypothermia
  • Critical Care

Interventions

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.

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.

Sponsors & Collaborators

  • Centre Hospitalier Departemental Vendee

    lead OTHER

Principal Investigators

  • Jean-Baptiste Lascarrou, MD · CHD Vendee

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2018-01-14
Completion
2018-08-09

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02722473 on ClinicalTrials.gov