Therapeutic Hypothermia After Cardiac Arrest in Non Shockable Rhythm
- Conditions
- Cardiac Arrest
- Interventions
- Procedure: Targeted controlled temperature between 36.5 and 37.5°CProcedure: Targeted controlled temperature between 32.5 and 33.5°C
- Registration Number
- NCT01994772
- Lead Sponsor
- Centre Hospitalier Departemental Vendee
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 584
- Cardiac arrest in non shockable rhythm
- Glasgow score ≤ 8
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Targeted controlled temperature between 36.5 and 37.5°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. Targeted controlled temperature between 32.5 and 33.5°C 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. Targeted controlled temperature between 32.5 and 33.5°C Targeted controlled temperature between 36.5 and 37.5°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.
- Primary Outcome Measures
Name Time Method Neurological outcome assessed with Cerebral Performance Category scale Day 90
- Secondary Outcome Measures
Name Time Method Intensive Care Unit Mortality 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 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 Day 90 Quality of life Score Day 90 Quality of life at day 90 will be assessed by 36-Items Short Form for Health Survey telephonic interview
Life autonomy 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 Day 90 Neurocognitive status will be assessed by telephonic validated version of Mini Mental State Examination
Post traumatic stress disorders symptoms Day 90 Post traumatic stress disorders symptoms will be assessed by Impact Event Scale Revised
Intensive Care Unit length of stay 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 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 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 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 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 2 days Ventilated Associated Pneumonia 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 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 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 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 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 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 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.
Trial Locations
- Locations (4)
Medical Intensive Care Unit
🇫🇷Tours, France
Medical Surgical Intensive Care Unit
🇫🇷Versailles, France
CHU Pointe à Pitre
🇬🇵Pointe-à-Pitre, Guadeloupe
Cochin University Hospital Center
🇫🇷Paris, France