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

NCT ID: NCT02722473

Last Updated: 2019-02-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 106 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2018-08-09

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.

Conditions

Cardiac Arrest; Hypothermia; Critical Care

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

NSE dosage "hypothermia arm"

Intervention Type: BIOLOGICAL

There 3 dosage of NSE per patient included: day 1, day 2 and day 3 during targeted temperature management between 33° and 37°C.

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

Group Type: PLACEBO_COMPARATOR

NSE dosage "normothermia arm"

Intervention Type: BIOLOGICAL

There 3 dosage of NSE per patient included: day 1, day 2 and day 3 during targeted temperature management at 37°C.

Interventions

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.

Intervention Type: 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.

Intervention Type: BIOLOGICAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Departemental Vendee

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean-Baptiste Lascarrou, MD

Role: STUDY_CHAIR

CHD Vendee

Locations

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

St-Malo, , France

Medical Intensive Care Unit

Tours, , France

Countries

France

References

Lascarrou JB, Miailhe AF, le Gouge A, Cariou A, Dequin PF, Reignier J, Coupez E, Quenot JP, Legriel S, Pichon N, Thevenin D, Boulain T, Frat JP, Vimeux S, Colin G, Desroys du Roure F. NSE as a predictor of death or poor neurological outcome after non-shockable cardiac arrest due to any cause: Ancillary study of HYPERION trial data. Resuscitation. 2021 Jan;158:193-200. doi: 10.1016/j.resuscitation.2020.11.035. Epub 2020 Dec 8.

Reference Type: DERIVED

PMID: 33301887 (View on PubMed)

Related Links

http://sjtrem.biomedcentral.com/articles/10.1186/s13049-015-0103-5

Trial Protocol published in SJTREM

Other Identifiers

NSE-HYPERION

Identifier Type: -

Identifier Source: org_study_id