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

NCT01683006 | Completed

• 1 other identifier: 753/2009UH
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Illness; Cardiac Arrest

Outcome Measures

Primary Outcomes (1)

• 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

  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 (1)

• Change of substrate oxidation rate (protein, fat and glucose) compared to baseline at 33C°

  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 (2)

• Difference in resting energy expenditure between patients with favorable and unfavorable outcome

  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

• Difference in substrate metabolism between patients with favorable and unfavorable outcome

  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

Study Arms (2)

Neuromuscular blocker group

ACTIVE COMPARATOR

Continuous application of neuromuscular blockers during therapeutic hypothermia. Bolus application of placebo in case of shivering.

Drug: Rocuronium

Placebo group

PLACEBO COMPARATOR

Continuous application of placebo during therapeutic hypothermia. Bolus application of neuromuscular blockers in case of shivering.

Drug: Placebo

Interventions

Rocuronium DRUG

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

Neuromuscular blocker group

Placebo DRUG

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

Placebo group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients receiving mild therapeutic hypothermia after cardiac arrest of presumed cardiopulmonary origin

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University Vienna

Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Critical Illness; Heart Arrest

Interventions

Rocuronium

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Ulrike Holzinger, MD

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Assoc Prof

Study Record Dates

• First Submitted: April 8, 2012
• First Posted: September 11, 2012
• Study Start: April 1, 2012
• Primary Completion: May 1, 2014
• Study Completion: November 1, 2014
• Last Updated: August 29, 2017

Record last verified: 2017-08

Locations

AU (1)