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

Critical Illness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01683006
• Other study ID #: 753/2009UH
• Status: Completed
• Phase: N/A
• First received: April 8, 2012
• Last updated: August 28, 2017
• Start date: April 2012
• Est. completion date: November 2014

Study information

• Verified date: August 2017
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: November 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Arrest
• Critical Illness
• Heart Arrest
• Hypothermia
• Paralysis

Intervention

Drug:
• Rocuronium
Continuous application of Rocuronium (0.5 mg/kg body weight/hour). Bolus application of placebo 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.

Locations

Country	Name	City	State
Austria	Medical University Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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: 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	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	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: 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	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
Primary	Change of resting energy expenditure compared to baseline at 33C°	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	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	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: 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	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