- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02711098
IL Ancillary Study of the Therapeutic Hypothermia After Nonshockable Cardiac Arrest Trial. (IL-HYPERION)
InterLeukine Ancillary Study of the Therapeutic Hypothermia After Nonshockable Cardiac Arrest Trial.
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.
IL Ancillary Study of HYPERION Trial will determine impact on inflammatory biomarkers of two temperature target for targeted temperature management (33°C or 37°C) after cardiac arrest in non-shockable rhythm.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Annecy, France, 74374
- Centre Hospitalier D'annecy
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Clermond Ferrand, France
- Medical Intensive Care Unit
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Dijon, France, 21079
- CHU Dijon
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La Roche Sur Yon, France
- Medical Surgical Intensive Care Unit
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Lens, France
- Medical Surgical Intensive Care Unit
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Limoges, France
- Medical Surgical Intensive Care Unit
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Montauban, France
- Medical Surgical Intensive Care Unit
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Nantes, France
- Medical Intensive Care Unit
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Orleans, France
- CHU Orleans
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Poitiers, France
- Medical Intensive Care Unit
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Rodez, France
- Medical Surgical Intensive Care Unit
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Saint Brieuc, France
- Medical Surgical Intensive Care Unit
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Saint Malo, France
- Medical Surgical Intensive Care Unit
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Tours, France
- Chu Tours
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
How is the study designed?
Design Details
- Primary Purpose: Treatment
- 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.
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There is 6 dosage of inflammatory biomarker per patient included: H0, H12, H24, H36, H48 and H72 during targeted temperature management between 33°C and 37°C.
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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.
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There is 6 dosage of inflammatory biomarker per patient included: H0, H12, H24, H36, H48 and H72 during targeted temperature management at 37°C.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Interleukine 6 level between H0 and H72
Time Frame: 72 hours
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Comparing the production of interleukin 6 (inflammatory cytokine) during targeted temperature management at 33 or 37 °C after cardiac arrest in non-shockable rhythm when help arrived and before the injection of adrenaline.
The analysis of the primary endpoint will be performed using an analysis of covariance, taking into account the basal value of interleukine 6. Necessary data will be pre-processed.
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72 hours
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Collaborators and Investigators
Investigators
- Study Chair: Jean-Baptiste Lascarrou, MD, CHD Vendée
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IL Ancillary Study of HYPERION
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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