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The purpose of this study is to evaluate the impact of muscle relaxing drugs on the energy rate during hypothermia after cardiac arrest.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neuromuscular blocker group | Active Comparator | Continuous application of neuromuscular blockers during therapeutic hypothermia. Bolus application of placebo in case of shivering. |
|
| Placebo group | Placebo Comparator | Continuous application of placebo during therapeutic hypothermia. Bolus application of neuromuscular blockers in case of shivering. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rocuronium | Drug | Continuous application of Rocuronium (0.5 mg/kg body weight/hour). Bolus application of placebo in case of shivering. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of resting energy expenditure compared to baseline at 33C° | resting energy expenditure will be assessed with indirect calorimetry at different measurement time points:
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change of substrate oxidation rate (protein, fat and glucose) compared to baseline at 33C° | substrate oxidation rates will be assessed with indirect calorimetry at different measurement time points:
|
| Measure | Description | Time Frame |
|---|---|---|
| Difference in resting energy expenditure between patients with favorable and unfavorable outcome | resting energy expenditure will be assessed with indirect calorimetry at different measurement time points:
|
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ulrike Holzinger, MD | Medical University of Vienna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University Vienna | Vienna | 1090 | Austria |
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| D006323 | Heart Arrest |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006331 | Heart Diseases |
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| ID | Term |
|---|---|
| D000077123 | Rocuronium |
| ID | Term |
|---|---|
| D000732 | Androstanols |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Placebo | Drug | Continuous application of placebo during therapeutic hypothermia. Bolus application of Rocuronium (0.5 mg/kg body weight) in case of shivering. |
|
| 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 |
| 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 |
| Difference in substrate metabolism between patients with favorable and unfavorable outcome | substrate oxidation rates will be assessed with indirect calorimetry at different measurement time points:
| 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 |
| D002318 | Cardiovascular Diseases |
| D011083 |
| Polycyclic Compounds |