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

Cardiac Arrest Clinical Trial

— NSE-HYPERION  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02722473
• Other study ID #: NSE-HYPERION
• Status: Completed
• Phase: Phase 3
• Start date: March 2016
• Est. completion date: August 9, 2018

Study information

• Verified date: February 2019
• Source: Centre Hospitalier Departemental Vendee
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: August 9, 2018
• Est. primary completion date: January 14, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Arrest
• Critical Care
• Heart Arrest
• Hypothermia

Intervention

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.
• 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.

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Departemental Vendee

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NSE level between day 1 and day 3		Day 3

External Links

•   Trial Protocol published in SJTREM