Overview

This trial is active, not recruiting.

Conditions critical illness, cardiac arrest
Treatments rocuronium, placebo
Sponsor Medical University of Vienna
Start date April 2012
End date September 2013
Trial size 40 participants
Trial identifier NCT01683006, 753/2009UH

Summary

The purpose of this study is to evaluate the impact of muscle relaxing drugs on the energy rate during hypothermia after cardiac arrest.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose supportive care
Arm
(Active Comparator)
Continuous application of neuromuscular blockers during therapeutic hypothermia. Bolus application of placebo in case of shivering.
rocuronium
Continuous application of Rocuronium (0.5 mg/kg body weight/hour). Bolus application of placebo in case of shivering.
(Placebo Comparator)
Continuous application of placebo during therapeutic hypothermia. Bolus application of neuromuscular blockers in case of shivering.
placebo
Continuous application of placebo during therapeutic hypothermia. Bolus application of Rocuronium (0.5 mg/kg body weight) in case of shivering.

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Influence of Skeletal Muscle Paralysis on Metabolism in Hypothermic Patients After Cardiac Arrest
Principal investigator Ulrike Holzinger, MD
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).
Trial information was received from ClinicalTrials.gov and was last updated in February 2014.
Information provided to ClinicalTrials.gov by Medical University of Vienna.