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Completed

NCT Number: NCT01683006

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

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

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Key information

Conditions

Critical Illness Cardiac Arrest Cardiovascular Diseases Disease Attributes Heart Arrest Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University Vienna

Vienna, 1090, Austria

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rocuronium

Drug

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

Bolus application of placebo in case of shivering.

Placebo

Drug

Continuous application of placebo during therapeutic hypothermia.

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

Primary outcomes

  1. 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:

    • 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

Secondary outcomes

  1. 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:

    • 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

Other outcomes

  1. 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:

    • 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

  2. 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:

    • 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

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Sep 11, 2012
Registry last updated
Aug 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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