Therapeutic Hypothermia After Cardiac Arrest in Non Shockable Rhythm (HYPERION)
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| ClinicalTrials.gov Identifier: NCT01994772 |
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Recruitment Status :
Completed
First Posted : November 26, 2013
Last Update Posted : January 16, 2019
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Sponsor:
Centre Hospitalier Departemental Vendee
Collaborator:
University Hospital, Tours
Information provided by (Responsible Party):
Centre Hospitalier Departemental Vendee
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Cardiac Arrest | Procedure: Targeted controlled temperature between 32.5 and 33.5°C Procedure: Targeted controlled temperature between 36.5 and 37.5°C | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 584 participants |
| Allocation: | Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | Single (Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Therapeutic Hypothermia After Cardiac Arrest in Non Shockable Rhythm at Rescue Arrival: The HYPERION Study |
| Actual Study Start Date : | January 26, 2014 |
| Actual Primary Completion Date : | April 9, 2018 |
| Actual Study Completion Date : | April 9, 2018 |
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| Arm | Intervention/treatment |
|---|---|
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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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Procedure: Targeted controlled temperature between 32.5 and 33.5°C
Therapeutic hypothermia ie targeted controlled temperature between 32.5° and 33.5°C will be induced in the active group. Usual method of controlled temperature will be use in ICU: internal active method or external active method.
Other Names:
Procedure: Targeted controlled temperature between 36.5 and 37.5°C Temperature was maintain between 36.5° and 37.5°C in the control group. In case of temperature superior to 37.5°C or inferior to 36.5°C, a pharmaceutical treatment and/or active cooling or warming was introduce to maintain temperature between the range of 36.5 - 37.5°C.
Other Name: Normothermia |
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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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Procedure: Targeted controlled temperature between 36.5 and 37.5°C
Temperature was maintain between 36.5° and 37.5°C in the control group. In case of temperature superior to 37.5°C or inferior to 36.5°C, a pharmaceutical treatment and/or active cooling or warming was introduce to maintain temperature between the range of 36.5 - 37.5°C.
Other Name: Normothermia |
Primary Outcome Measures :
- Neurological outcome assessed with Cerebral Performance Category scale [ Time Frame: Day 90 ]
Secondary Outcome Measures :
- Intensive Care Unit Mortality [ Time Frame: Discharge from Intensive Care Unit, an expected average of 7 days ]Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 7 days.
- Hospital Mortality [ Time Frame: Discharge from hospital, an expected average of 2 weeks ]Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
- Mortality at day 90 [ Time Frame: Day 90 ]
- Quality of life Score [ Time Frame: Day 90 ]Quality of life at day 90 will be assessed by 36-Items Short Form for Health Survey telephonic interview
- Life autonomy [ Time Frame: Day 90 ]Life autonomy will be assessed by Index Activity of Daily Living, modified Barthel index, and by two normative question about life autonomy
- Neurocognitive evaluation [ Time Frame: Day 90 ]Neurocognitive status will be assessed by telephonic validated version of Mini Mental State Examination
- Post traumatic stress disorders symptoms [ Time Frame: Day 90 ]Post traumatic stress disorders symptoms will be assessed by Impact Event Scale Revised
- Intensive Care Unit length of stay [ Time Frame: Discharge from Intensive Care Unit, an expected average of 7 days ]Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 7 days
- Hospital length of stay [ Time Frame: Discharge from hospital, an expected average of 2 weeks ]Participants will be followed for the duration of hospital stay, an expected average of 2 weeks.
- Mechanical ventilation duration [ Time Frame: Time from extubation, an expected average of 4 days ]Participants will be followed for the duration of mechanical ventilation, an expected average of 4 days
- Severe hemorrhage [ Time Frame: Intensive care unit length of stay, an expected average of 7 days ]Severe hemorrhage is define by transfusion of 1 or more blood product requirement and/or intracranial hemorrhage. Participants will be followed for the duration of Intensive care unit stay, an expected average of 7 days.
- Nosocomial Bloodstream infection [ Time Frame: Intensive care unit length of stay, an expected average of 7 days ]Participants will be followed for the duration of Intensive care unit stay, an expected average of 7 days.
- Early onset pneumonia [ Time Frame: 2 days ]
- Ventilated Associated Pneumonia [ Time Frame: Duration of mechanical ventilation, an expected average of 4 days ]Participants will be followed for the duration of mechanical ventilation, an expected average of 4 days
- Central Veinous Catheter infection [ Time Frame: Intensive care unit length of stay, an expected average of 7 days ]Participants will be followed for the duration of Intensive care unit stay, an expected average of 7 days.
- Total dose of inotropic drugs [ Time Frame: 48 hours ]Total dose of different inotropic drugs (Epinephrine, Norepinephrine, Dobutamine) will be compare between 2 groups during targetted controlled temperature management period.
- Extra renal support requirement [ Time Frame: Intensive care unit length of stay, an expected 7 days ]Participants will be followed for the duration of Intensive care unit stay, an expected average of 7 days
- Acute pulmonary oedema by left ventricular failure [ Time Frame: Intensive care length of stay, an expected 7 days ]Participants will be followed for the duration of Intensive care unit stay, an expected average of 7 days.
- Seizure [ Time Frame: Intensive care length of stay, an expected 7 days ]Participants will be followed for the duration of Intensive care unit stay, an expected average of 7 days
- Severe arrythmia [ Time Frame: Intensive care unit length of stay, an expected 7 days ]Severe arrythmia will be define by salvo of ventricular extrasystole, ventricular fibrillation, ventricular tachycardia, need an external shock, need anti-arrhythmic treatment. Participants will be followed for the duration of Intensive Care Unit stay, an expected average of 7 days.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Cardiac arrest in non shockable rhythm
- Glasgow score ≤ 8
Exclusion Criteria:
- No flow > 10 min
- Low flow > 60 min
- Major hemodynamic instability
- Delay between cardiac arrest and inclusion > 300 min
- Cirrhosis Child C
- Age < 18 years
- Pregnant women
- Patient with no liberty
- Lack of informed consent
- Prior inclusion in a research protocol involving cardiac arrest with draw, and whose primary endpoint focuses on the evaluation of a neurological score Day 90
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01994772
Locations
Show 26 study locations
Sponsors and Collaborators
Centre Hospitalier Departemental Vendee
University Hospital, Tours
Investigators
| Study Chair: | Jean Baptiste Lascarrou, MD | CHU Nantes |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Centre Hospitalier Departemental Vendee |
| ClinicalTrials.gov Identifier: | NCT01994772 |
| Other Study ID Numbers: |
RCB 2012-A00405-38 |
| First Posted: | November 26, 2013 Key Record Dates |
| Last Update Posted: | January 16, 2019 |
| Last Verified: | January 2019 |
Keywords provided by Centre Hospitalier Departemental Vendee:
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Therapeutic hypothermia Targeted controlled temperature Cardiac arrest Non shockable rhythm successful resuscitation |
Additional relevant MeSH terms:
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Heart Arrest Hypothermia Heart Diseases Cardiovascular Diseases Body Temperature Changes |