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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Ulrike Holzinger, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01683006
First received: April 8, 2012
Last updated: February 4, 2014
Last verified: February 2014
  Purpose

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


Condition Intervention
Critical Illness
Cardiac Arrest
Drug: Rocuronium
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Influence of Skeletal Muscle Paralysis on Metabolism in Hypothermic Patients After Cardiac Arrest

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    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


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    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


Other Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    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

  • 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 ] [ Designated as safety issue: No ]

    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


Estimated Enrollment: 40
Study Start Date: April 2012
Estimated Study Completion Date: April 2014
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01683006

Locations
Austria
Medical University Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Ulrike Holzinger, MD Medical University of Vienna
  More Information

No publications provided

Responsible Party: Ulrike Holzinger, MD, Assoc Prof, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01683006     History of Changes
Other Study ID Numbers: 753/2009UH
Study First Received: April 8, 2012
Last Updated: February 4, 2014
Health Authority: Austria: Ethikkommission

Additional relevant MeSH terms:
Critical Illness
Heart Arrest
Cardiovascular Diseases
Disease Attributes
Heart Diseases
Pathologic Processes
Neuromuscular Blocking Agents
Rocuronium
Neuromuscular Agents
Neuromuscular Nondepolarizing Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 21, 2014