Skeletal Muscle Paralysis in Hypothermic Patients After Cardiac Arrest (RELAX)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by Medical University of Vienna
Sponsor:
Information provided by (Responsible Party):
Heidrun Losert, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01719770
First received: July 6, 2011
Last updated: October 30, 2012
Last verified: October 2012

July 6, 2011
October 30, 2012
November 2010
January 2013   (final data collection date for primary outcome measure)
Number of shivering episodes [ Time Frame: during cooling period (mild therapeutic hypothermia will be performed for 24 hours after cooling initiation, rewarming with 0,4°C per hour until a body core temperature of 36°C is reached); total time of approximately 31 hours ] [ Designated as safety issue: No ]
Shivering episodes will be detected according to the Shivering Assessment Scale
Same as current
Complete list of historical versions of study NCT01719770 on ClinicalTrials.gov Archive Site
  • Elapsed time to target temperature [ Time Frame: Time from starting the cooling procedure until target temperature is reached - approximately 4 hours after cooling initiation ] [ Designated as safety issue: No ]
  • Dissipated energy to reach the target temperature [ Time Frame: Time from starting the cooling procedure until target temperature is reached - approximately 4 hours after cooling initiation ] [ Designated as safety issue: No ]
  • Changes in basal metabolism due to shivering or elevated stress levels [ Time Frame: during the first 72 hours after cardiac arrest ] [ Designated as safety issue: No ]
  • Depth of relaxation [ Time Frame: during cooling and rewarming period, which will be approximately 30 hours up to 48 hours after initiation of cooling ] [ Designated as safety issue: Yes ]
    via train of four measurement
  • Changes in serum levels of midazolam, fentanyl and rocuronium [ Time Frame: within the first 48 hours of treatment ] [ Designated as safety issue: Yes ]
  • Number of necessary boli of rocuronium [ Time Frame: during colling period (mild therapeutic hypothermia will be performed for 24 hours after cooling initiation, rewarming with 0,4°C per hour until a body core temperature of 36°C is reached); total time of approximately 31 hours ] [ Designated as safety issue: Yes ]
    In case of a shivering episode, a bolus of rocuronium will be administered (0,25mg/kg)
Same as current
Not Provided
Not Provided
 
Skeletal Muscle Paralysis in Hypothermic Patients After Cardiac Arrest
Requirement of Skeletal Muscle Paralysis in Hypothermic Patients After Cardiac Arrest - a Pilot 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. Since neuromuscular blockers are accused to be associated with various side effects causing serious harm and/or leading to prolong ICU stay. So economical use seems to be reasonable. Furthermore, the use of neuromuscular blockers may mask epileptic activity. Therefore, post hypoxic seizures might remain undetected.

Aim of this study is to investigate if a continuous application of neuromuscular blockers is necessary to prevent shivering and thereby avoid the counter regulation to achieve the target temperature as soon as possible in mild hypothermic therapy after cardiac arrest.

A single center (university hospital) study. Randomized, double blinded, double dummy study design. Eligible are all adult patients after successful resuscitation due to cardiac arrest of presumed cardiac origin.

All patients receiving mild therapeutic hypothermia after cardiac arrest of presumed cardiopulmonary origin will be included.

Patients <18 years, 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 and patients with known epileptic disease will be excluded.

Primary outcome:

Shivering episodes will be scored with the Shivering Assessment Scale.

Secondary outcome:

Total doses of rocuronium, time to target core temperature of 33°C, dissipated energy and total energy needed during the cooling period will be compared between the two groups.

Changes in basal metabolism and depth of relaxation will be ascertained. Furthermore, serum levels of midazolam, fentanyl, rocuronium and stress hormones will be measured.

Train-of-four will be performed to assess the depth of relaxation. Sedation will be monitored via bispectral index; measurement of metabolic activity will be evaluated using indirect calorimetry. Additionally, EEG will be performed to detect epileptiform activities. Blood will be drawn to measure levels of midazolam, fentanyl and rocuronium.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator)
Primary Purpose: Treatment
  • Cardiac Arrest With Successful Resuscitation
  • Hypothermia
  • Skeletal Muscle Relaxant Overdose
  • Drug: rocuronium
    continuous application of rocuronium 0,25mg/kg/h (blinded), in case of shivering episode bolus sodium-chloride (blinded)
    Other Name: Esmeron
  • Other: placebo
    continuous infusion of sodium-chloride (blinded), in case of shivering episode application of rocuronium 0,25mg/kg (blinded)
    Other Name: sodium-chloride
  • Active Comparator: Rocuronium
    Continuous infusion of rocuronium with 0,25mg/kg (blinded) for 29 hours after initiation of mild therapeutic hypothermia
    Intervention: Drug: rocuronium
  • Placebo Comparator: Placebo
    Continuous infusion of sodium-chloride (placebo) and rocuronium bolus (0,25mg/kg)in case of shivering episode (blinded)
    Intervention: Other: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
July 2013
January 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • all patients receiving mild therapeutic hypothermia after cardiac arrest
  • cardiac arrest due to cardiopulmonary origin

Exclusion Criteria:

  • patients younger than 18 years
  • traumatic cardiac arrest
  • cardiac arrest due to exsanguination, strangulation, smoke inhalation, drug overdose, electrocution, hanging or drowning
  • known or clinically apparent pregnancy
  • no treatment with mild therapeutic hypothermia because of an AND order
  • terminal illness
  • a body core temperature below 35°C at hospital admission
  • known allergic reaction against rocuronium
  • history of myasthenia gravis
  • obvious intoxication
  • ward of the state or prisoner
  • known epileptic disease
  • cardiac arrest >6 hours prior to hospital admission
Both
18 Years and older
No
Contact: Heidrun Losert, MD 00431404001964 heidrun.losert@meduniwien.ac.at
Contact: Mathias Stöckl, MD 00431404001964 mathias.stoeckl@meduniwien.ac.at
Austria
 
NCT01719770
RELAX1
Yes
Heidrun Losert, Medical University of Vienna
Medical University of Vienna
Not Provided
Principal Investigator: Heidrun Losert, MD Medical University Vienna, Department of Emergency Medicine
Medical University of Vienna
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP