Clinical trial NCT01683006: Influence of Skeletal Muscle Paralysis on Metabolism in Hypothermic Patients After Cardiac Arrest
Official title: Influence of Skeletal Muscle Paralysis on Metabolism in Hypothermic Patients After Cardiac Arrest
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critical Illness
Cardiac Arrest
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2012-09-11
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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).

Eligibility criteria: 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

Primary outcomes:
measure: Change of resting energy expenditure compared to baseline at 33C°
timeFrame: 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°
timeFrame: 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
Other outcomes:
measure: Difference in resting energy expenditure between patients with favorable and unfavorable outcome
timeFrame: 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: Difference in substrate metabolism between patients with favorable and unfavorable outcome
timeFrame: 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
Locations:
city: Vienna
country: Austria
facility: Medical University Vienna
Study officials:
affiliation: Medical University of Vienna
name: Ulrike Holzinger, MD
role: PRINCIPAL_INVESTIGATOR
References: