Cardiac Arrest, Critical Illness
Conditions
Brief summary
The purpose of this study is to evaluate the impact of muscle relaxing drugs on the energy rate during hypothermia after cardiac arrest.
Detailed description
Mild hypothermia improves neurological outcome after cardiac arrest. Neuromuscular blockers are in use, together with analgesia and sedation, during the cooling process in many centers to prevent shivering. However, neuromuscular blockers are accused to be associated with various side effects causing serious harm and/or leading to prolonged ICU stay. Furthermore, the use of neuromuscular blockers may mask epileptic activity. Therefore, the advantages and disadvantages of neuromuscular blockers during therapeutic hypothermia need to be re-evaluated. Aim of this study is to investigate if continuous application of neuromuscular blockers is necessary to prevent shivering and thereby avoiding an increase in energy expenditure in patients during therapeutic hypothermia and rewarming after cardiac arrest (initial 72h).
Interventions
DRUGRocuronium
Continuous application of Rocuronium (0.5 mg/kg body weight/hour). Bolus application of placebo in case of shivering.
DRUGPlacebo
Continuous application of placebo during therapeutic hypothermia. Bolus application of Rocuronium (0.5 mg/kg body weight) in case of shivering.
Sponsors
Medical University of Vienna
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All patients receiving mild therapeutic hypothermia after cardiac arrest of presumed cardiopulmonary origin
Exclusion criteria
* age \< 18 * cardiac arrest \>6 hours before admittance at the hospital * patients with known or clinically apparent pregnancy * patients who reach our hospital with a body temperature below 35°C * patients with known allergic reactions against rocuronium * patients with a history of myasthenia gravis * patients with obvious intoxication * wards of the state/prisoners * patients with known epileptic disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of resting energy expenditure compared to baseline at 33C° | initial 72h after cardiac arrest at defined temperatures or timepoints: 1) 33°C 2) 34.5°C 3) 36 °C 4) 36.5 - 37.5 °C 5) after 48-72h | resting energy expenditure will be assessed with indirect calorimetry at different measurement time points: 1. 12-24 h after initiation of mild hypothermia (33C°) 2. during warming up (at 34.5°C) 3. during warming up (at 36°C) 4. during warming up (at 36.5°C - 37.5°C) 5. normal Temperature, after 48 - 72 h after initiation of mild hypothermia |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of substrate oxidation rate (protein, fat and glucose) compared to baseline at 33C° | initial 72h after cardiac arrest at defined temperatures or timepoints: 1) 33°C 2) 34.5°C 3) 36 °C 4) 36.5 - 37.5 °C 5) after 48-72h | substrate oxidation rates will be assessed with indirect calorimetry at different measurement time points: 1. 12-24 h after initiation of mild hypothermia (33C°) 2. during warming up (at 34.5°C) 3. during warming up (at 36°C) 4. during warming up (at 36.5°C - 37.5°C) 5. at normal Temperature, after 48 - 72 h after initiation of mild hypothermia |
Other
| Measure | Time frame | Description |
|---|---|---|
| Difference in resting energy expenditure between patients with favorable and unfavorable outcome | initial 72h after cardiac arrest at defined temperatures or timepoints: 1) 33°C 2) 34.5°C 3) 36 °C 4) 36.5 - 37.5 °C 5) after 48-72h | resting energy expenditure will be assessed with indirect calorimetry at different measurement time points: 1. 12-24 h after initiation of mild hypothermia (33C°) 2. during warming up (at 34.5°C) 3. during warming up (at 36°C) 4. during warming up (at 36.5°C - 37.5°C) 5. normal Temperature, after 48 - 72 h after initiation of mild hypothermia |
| Difference in substrate metabolism between patients with favorable and unfavorable outcome | initial 72h after cardiac arrest at defined temperatures or timepoints: 1) 33°C 2) 34.5°C 3) 36 °C 4) 36.5 - 37.5 °C 5) after 48-72h | substrate oxidation rates will be assessed with indirect calorimetry at different measurement time points: 1. 12-24 h after initiation of mild hypothermia (33C°) 2. during warming up (at 34.5°C) 3. during warming up (at 36°C) 4. during warming up (at 36.5°C - 37.5°C) 5. at normal Temperature, after 48 - 72 h after initiation of mild hypothermia |
Countries
Austria
Outcome results
None listed