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

August 28, 2017 updated by: Ulrike Holzinger, Medical University of Vienna
The purpose of this study is to evaluate the impact of muscle relaxing drugs on the energy rate during hypothermia after cardiac arrest.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

43

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Medical University Vienna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Neuromuscular blocker group

Continuous application of neuromuscular blockers during therapeutic hypothermia.

Bolus application of placebo in case of shivering.
Drug: Rocuronium

Continuous application of Rocuronium (0.5 mg/kg body weight/hour).

Bolus application of placebo in case of shivering.
Placebo Comparator: Placebo group

Continuous application of placebo during therapeutic hypothermia.

Bolus application of neuromuscular blockers in case of shivering.
Drug: Placebo

Continuous application of placebo during therapeutic hypothermia.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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

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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in resting energy expenditure between patients with favorable and unfavorable outcome
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

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
Difference in substrate metabolism between patients with favorable and unfavorable outcome
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

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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Investigators

  • Principal Investigator: Ulrike Holzinger, MD, Medical University of Vienna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2012

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

April 8, 2012

First Submitted That Met QC Criteria

September 6, 2012

First Posted (Estimate)

September 11, 2012

Study Record Updates

Last Update Posted (Actual)

August 29, 2017

Last Update Submitted That Met QC Criteria

August 28, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 753/2009UH

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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