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

Primary Purpose

Critical Illness, Cardiac Arrest

Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Rocuronium
Placebo
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Critical Illness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medical University Vienna

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Neuromuscular blocker group

Placebo group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
April 8, 2012
Last Updated
August 28, 2017
Sponsor
Medical University of Vienna
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1. Study Identification

Unique Protocol Identification Number
NCT01683006
Brief Title
Influence of Skeletal Muscle Paralysis on Metabolism in Hypothermic Patients After Cardiac Arrest
Official Title
Influence of Skeletal Muscle Paralysis on Metabolism in Hypothermic Patients After Cardiac Arrest
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
April 2012 (Actual)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness, Cardiac Arrest

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Neuromuscular blocker group
Arm Type
Active Comparator
Arm Description
Continuous application of neuromuscular blockers during therapeutic hypothermia. Bolus application of placebo in case of shivering.
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Continuous application of placebo during therapeutic hypothermia. Bolus application of neuromuscular blockers in case of shivering.
Intervention Type
Drug
Intervention Name(s)
Rocuronium
Intervention Description
Continuous application of Rocuronium (0.5 mg/kg body weight/hour). Bolus application of placebo in case of shivering.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Continuous application of placebo during therapeutic hypothermia. Bolus application of Rocuronium (0.5 mg/kg body weight) in case of shivering.
Primary Outcome Measure Information:
Title
Change of resting energy expenditure compared to baseline at 33C°
Description
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
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
Secondary Outcome Measure Information:
Title
Change of substrate oxidation rate (protein, fat and glucose) compared to baseline at 33C°
Description
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
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
Other Pre-specified Outcome Measures:
Title
Difference in resting energy expenditure between patients with favorable and unfavorable outcome
Description
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
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
Title
Difference in substrate metabolism between patients with favorable and unfavorable outcome
Description
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
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ulrike Holzinger, MD
Organizational Affiliation
Medical University of Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria

12. IPD Sharing Statement

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

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