Influence of Skeletal Muscle Paralysis on Metabolism in Hypothermic Patients After Cardiac Arrest
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Purpose
The purpose of this study is to evaluate the impact of muscle relaxing drugs on the energy rate during hypothermia after cardiac arrest.
| Condition | Intervention |
|---|---|
|
Critical Illness Cardiac Arrest |
Drug: Rocuronium Drug: Placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Supportive Care |
| Official Title: | Influence of Skeletal Muscle Paralysis on Metabolism in Hypothermic Patients After Cardiac Arrest |
- Change of resting energy expenditure compared to baseline at 33C° [ Time Frame: 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 ] [ Designated as safety issue: No ]
resting energy expenditure will be assessed with indirect calorimetry at different measurement time points:
- 12-24 h after initiation of mild hypothermia (33C°)
- during warming up (at 34.5°C)
- during warming up (at 36°C)
- during warming up (at 36.5°C - 37.5°C)
- normal Temperature, after 48 - 72 h after initiation of mild hypothermia
- Change of substrate oxidation rate (protein, fat and glucose) compared to baseline at 33C° [ Time Frame: 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 ] [ Designated as safety issue: No ]
substrate oxidation rates will be assessed with indirect calorimetry at different measurement time points:
- 12-24 h after initiation of mild hypothermia (33C°)
- during warming up (at 34.5°C)
- during warming up (at 36°C)
- during warming up (at 36.5°C - 37.5°C)
- at normal Temperature, after 48 - 72 h after initiation of mild hypothermia
- Difference in resting energy expenditure between patients with favorable and unfavorable outcome [ Time Frame: 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 ] [ Designated as safety issue: No ]
resting energy expenditure will be assessed with indirect calorimetry at different measurement time points:
- 12-24 h after initiation of mild hypothermia (33C°)
- during warming up (at 34.5°C)
- during warming up (at 36°C)
- during warming up (at 36.5°C - 37.5°C)
- normal Temperature, after 48 - 72 h after initiation of mild hypothermia
- Difference in substrate metabolism between patients with favorable and unfavorable outcome [ Time Frame: 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 ] [ Designated as safety issue: No ]
substrate oxidation rates will be assessed with indirect calorimetry at different measurement time points:
- 12-24 h after initiation of mild hypothermia (33C°)
- during warming up (at 34.5°C)
- during warming up (at 36°C)
- during warming up (at 36.5°C - 37.5°C)
- at normal Temperature, after 48 - 72 h after initiation of mild hypothermia
| Estimated Enrollment: | 40 |
| Study Start Date: | April 2012 |
| Estimated Study Completion Date: | April 2014 |
| Estimated Primary Completion Date: | April 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Neuromuscular blocker group
Continuous application of neuromuscular blockers during therapeutic hypothermia. Bolus application of placebo in case of shivering. |
Drug: Rocuronium
Continuous application of Rocuronium (0.5 mg/kg body weight/hour). Bolus application of placebo in case of shivering. |
|
Placebo Comparator: Placebo group
Continuous application of placebo during therapeutic hypothermia. Bolus application of neuromuscular blockers in case of shivering. |
Drug: Placebo
Continuous application of placebo during therapeutic hypothermia. Bolus application of Rocuronium (0.5 mg/kg body weight) in case of shivering. |
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).
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts 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
Contacts and Locations| Contact: Ulrike Holzinger, MD | 0043 1 40400 ext 4767 | ulrike.holzinger@meduniwien.ac.at |
| Contact: Richard Brunner, MD | 0043 1 40400 ext 4766 | richard.brunner@meduniwien.ac.at |
| Austria | |
| Medical University Vienna | Recruiting |
| Vienna, Austria, 1090 | |
| Contact: Ulrike Holzinger, MD 0043 1 40400 ext 4767 ulrike.holzinger@meduniwien.ac.at | |
| Contact: Richard Brunner, MD 0043 1 40400 ext 4766 richard.brunner@meduniwien.ac.at | |
| Principal Investigator: Ulrike Holzinger, MD | |
| Principal Investigator: | Ulrike Holzinger, MD | Medical University of Vienna |
More Information
No publications provided
| Responsible Party: | Ulrike Holzinger, MD, Assoc Prof, Medical University of Vienna |
| ClinicalTrials.gov Identifier: | NCT01683006 History of Changes |
| Other Study ID Numbers: | 753/2009UH |
| Study First Received: | April 8, 2012 |
| Last Updated: | September 6, 2012 |
| Health Authority: | Austria: Ethikkommission |
Additional relevant MeSH terms:
|
Critical Illness Heart Arrest Hypothermia Paralysis Disease Attributes Pathologic Processes Heart Diseases Cardiovascular Diseases Body Temperature Changes Signs and Symptoms |
Neurologic Manifestations Nervous System Diseases Neuromuscular Blocking Agents Rocuronium Neuromuscular Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Neuromuscular Nondepolarizing Agents |
ClinicalTrials.gov processed this record on June 18, 2013