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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2014-11-30

Brief Summary

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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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Detailed Description

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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).

Conditions

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Critical Illness Cardiac Arrest

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Neuromuscular blocker group

Continuous application of neuromuscular blockers during therapeutic hypothermia.

Bolus application of placebo in case of shivering.

Group Type ACTIVE_COMPARATOR

Rocuronium

Intervention Type DRUG

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

Bolus application of placebo in case of shivering.

Placebo group

Continuous application of placebo during therapeutic hypothermia.

Bolus application of neuromuscular blockers in case of shivering.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Continuous application of placebo during therapeutic hypothermia.

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

Interventions

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Rocuronium

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

Bolus application of placebo in case of shivering.

Intervention Type DRUG

Placebo

Continuous application of placebo during therapeutic hypothermia.

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No