NSE Ancillary Study of The Therapeutic Hypothermia After Nonshockable Cardiac Arrest Trial. (NSE-HYPERION)
Primary Purpose
Cardiac Arrest, Hypothermia, Critical Care
Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
NSE dosage "hypothermia arm"
NSE dosage "normothermia arm"
Sponsored by
About this trial
This is an interventional diagnostic trial for Cardiac Arrest
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
Sites / Locations
- Medical Surgical Intensive Care Unit
- Medical Intensive Care Unit
- Medical Intensive Care Unit
- Medical Surgical Intensive Care Unit
- Medical Surgical Intensive Care Unit
- Medical Surgical Intensive Care Unit
- Medical Surgical Intensive Care Unit
- Medical Intensive Care Unit
- Medical Surgical Intensive Care Unit
- Medical Intensive Care Unit
- Medical Surgical Intensive Care Unit
- Medical Surgical Intensive Care Unit
- Medical Surgical Intensive Care Unit
- Medical Intensive Care Unit
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Targeted controlled temperature between 32.5 and 33.5°C
Targeted controlled temperature between 36.5 and 37.5°C
Arm Description
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.
Patients will be placed in targeted temperature control between 36.5 and 37.5°C for 48 hours
Outcomes
Primary Outcome Measures
NSE level between day 1 and day 3
Secondary Outcome Measures
Full Information
NCT ID
NCT02722473
First Posted
March 24, 2016
Last Updated
February 22, 2019
Sponsor
Centre Hospitalier Departemental Vendee
1. Study Identification
Unique Protocol Identification Number
NCT02722473
Brief Title
NSE Ancillary Study of The Therapeutic Hypothermia After Nonshockable Cardiac Arrest Trial.
Acronym
NSE-HYPERION
Official Title
NSE Ancillary Study of The Therapeutic Hypothermia After Nonshockable Cardiac Arrest Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
January 14, 2018 (Actual)
Study Completion Date
August 9, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Departemental Vendee
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Arrest, Hypothermia, Critical Care
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
106 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Targeted controlled temperature between 32.5 and 33.5°C
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Targeted controlled temperature between 36.5 and 37.5°C
Arm Type
Placebo Comparator
Arm Description
Patients will be placed in targeted temperature control between 36.5 and 37.5°C for 48 hours
Intervention Type
Biological
Intervention Name(s)
NSE dosage "hypothermia arm"
Intervention Description
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
Intervention Name(s)
NSE dosage "normothermia arm"
Intervention Description
There 3 dosage of NSE per patient included: day 1, day 2 and day 3 during targeted temperature management at 37°C.
Primary Outcome Measure Information:
Title
NSE level between day 1 and day 3
Time Frame
Day 3
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Baptiste Lascarrou, MD
Organizational Affiliation
CHD Vendee
Official's Role
Study Chair
Facility Information:
Facility Name
Medical Surgical Intensive Care Unit
City
Annecy
Country
France
Facility Name
Medical Intensive Care Unit
City
Clermont-Ferrand
Country
France
Facility Name
Medical Intensive Care Unit
City
Dijon
Country
France
Facility Name
Medical Surgical Intensive Care Unit
City
La Roche Sur Yon
Country
France
Facility Name
Medical Surgical Intensive Care Unit
City
Lens
Country
France
Facility Name
Medical Surgical Intensive Care Unit
City
Limoges
Country
France
Facility Name
Medical Surgical Intensive Care Unit
City
Montauban
Country
France
Facility Name
Medical Intensive Care Unit
City
Nantes
Country
France
Facility Name
Medical Surgical Intensive Care Unit
City
Orléans
Country
France
Facility Name
Medical Intensive Care Unit
City
Poitiers
Country
France
Facility Name
Medical Surgical Intensive Care Unit
City
Rodez
Country
France
Facility Name
Medical Surgical Intensive Care Unit
City
Saint Brieuc
Country
France
Facility Name
Medical Surgical Intensive Care Unit
City
Saint Malo
Country
France
Facility Name
Medical Intensive Care Unit
City
Tours
Country
France
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33301887
Citation
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.
Results Reference
derived
Links:
URL
http://sjtrem.biomedcentral.com/articles/10.1186/s13049-015-0103-5
Description
Trial Protocol published in SJTREM
Learn more about this trial
NSE Ancillary Study of The Therapeutic Hypothermia After Nonshockable Cardiac Arrest Trial.
We'll reach out to this number within 24 hrs