Influence of Skeletal Muscle Paralysis on Metabolism in Hypothermic Patients After Cardiac Arrest

Medical University of Vienna43 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Enrollment

Conditions

Critical Illness Cardiac Arrest

Interventions

RocuroniumDRUG

Continuous application of Rocuronium (0.5 mg/kg body weight/hour). Bolus application of placebo in case of shivering.

PlaceboDRUG

Continuous application of placebo during therapeutic hypothermia. Bolus application of Rocuronium (0.5 mg/kg body weight) in case of shivering.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Medical University Vienna

Vienna, Austria

Outcomes

Primary Outcomes

Change of resting energy expenditure compared to baseline at 33C°

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

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

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: 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

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

Data from ClinicalTrials.gov

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