Clinical Trial Results:
Requirement of Skeletal Muscle Paralysis in Hypothermic Patients after Cardiac Arrest. A pilot study
Summary
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EudraCT number |
2009-015771-27 |
Trial protocol |
AT |
Global end of trial date |
12 Dec 2014
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Results information
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Results version number |
v1(current) |
This version publication date |
07 Oct 2020
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First version publication date |
07 Oct 2020
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Other versions |
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Summary report(s) |
Relax_Publication |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
V3
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01719770 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Medical University Vienna, Emergemcy Medicine
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Sponsor organisation address |
Währinger Gürtel 18-20, Vienna, Austria, 1090 Wien
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Public contact |
Emergency Department, Medical University Vienna, Emergency Department, Medical University Vienna, +43 14040039530, heidrun.losert@meduniwien.ac.at
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Scientific contact |
Emergency Department, Medical University Vienna, Emergency Department, Medical University Vienna, +43 14040039530,
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
12 Dec 2014
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
30 Sep 2014
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Global end of trial reached? |
Yes
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Global end of trial date |
12 Dec 2014
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
Number of shivering episodes will be assessed and compared between the two groups with the Shivering Assessment Scale and the EMG.
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Protection of trial subjects |
Intensive Care Patients were treated as usually, no painful or distressing examinations were done in these fully sedated, intubated patients.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Nov 2010
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Austria: 63
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Worldwide total number of subjects |
63
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EEA total number of subjects |
63
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
39
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From 65 to 84 years |
22
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85 years and over |
2
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Recruitment
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Recruitment details |
All patients with out of hospital cardiac arrest older than 18 years who presented to the emergency department with sustained return of spontaneous circulation who remained comatose. | |||||||||
Pre-assignment
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Screening details |
Cardiac arrest had to be of presumed cardiopulmonary origin. Core body temperature had to be equal or above 35°C. | |||||||||
Period 1
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Period 1 title |
Overall trial (overall period)
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | |||||||||
Roles blinded |
Investigator, Data analyst, Subject, Assessor, Carer | |||||||||
Blinding implementation details |
A sealed envelope was opened by a nurse not involved in the treatment of the patient or the study. This person prepared the blinded anti-shivering bolus and continuous medication (neuromuscular blockers or saline)
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Continuous-NMB-group | |||||||||
Arm description |
This group received a continuous rocuronium infusion and in case of shivering an saline bolus | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
rocuronium
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Injection
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Routes of administration |
Intravenous use
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Dosage and administration details |
0.25mg/kg/h
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Arm title
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Bolus-NMB-group | |||||||||
Arm description |
Patients received saline infusion and in case of shivering a rocuronium bolus | |||||||||
Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
rocuronium
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Injection
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Routes of administration |
Intravenous bolus use
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Dosage and administration details |
0.025ml/kg in case of shivering
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Baseline characteristics reporting groups
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Reporting group title |
Continuous-NMB-group
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Reporting group description |
This group received a continuous rocuronium infusion and in case of shivering an saline bolus | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Bolus-NMB-group
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Reporting group description |
Patients received saline infusion and in case of shivering a rocuronium bolus | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Continuous-NMB-group
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Reporting group description |
This group received a continuous rocuronium infusion and in case of shivering an saline bolus | ||
Reporting group title |
Bolus-NMB-group
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Reporting group description |
Patients received saline infusion and in case of shivering a rocuronium bolus |
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End point title |
subjects with shivering episodes | ||||||||||||
End point description |
Percentage of patients with shivering episodes
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End point type |
Primary
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End point timeframe |
study period
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Statistical analysis title |
primary analysis patients with shivering episodes | ||||||||||||
Comparison groups |
Continuous-NMB-group v Bolus-NMB-group
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Number of subjects included in analysis |
63
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
P-value |
< 0.05 | ||||||||||||
Method |
Chi-squared | ||||||||||||
Confidence interval |
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End point title |
number of shivering episodes | |||||||||
End point description |
Median shivering episodes per group were reported
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End point type |
Secondary
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End point timeframe |
whole study period
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Statistical analysis title |
number of shivering episodes | |||||||||
Comparison groups |
Bolus-NMB-group v Continuous-NMB-group
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Number of subjects included in analysis |
63
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Analysis specification |
Pre-specified
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Analysis type |
superiority | |||||||||
P-value |
< 0.05 | |||||||||
Method |
Wilcoxon (Mann-Whitney) | |||||||||
Confidence interval |
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End point title |
Doses of midazolam | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
whole study period
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No statistical analyses for this end point |
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End point title |
Doses of fentanyl | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
whole study period
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No statistical analyses for this end point |
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End point title |
Cumulative doses of rocuronium | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
whole study period
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No statistical analyses for this end point |
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End point title |
Overall mortality | |||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
whole study period
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No statistical analyses for this end point |
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End point title |
Rate of favorable neurologic function after 12 months | |||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
whole study period
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No statistical analyses for this end point |
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Adverse events information [1]
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Timeframe for reporting adverse events |
whole study period
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
23
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Reporting groups
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Reporting group title |
Bolus Neuromuscular Blocker Group
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Continuous Neuromuscular Blocker Group
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||
Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: There were no non-serious adverse events |
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Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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30 Jun 2010 |
The dosage of continuous rocuronium was adapted lower levels
EMG will not be performed, only shivering assessment scale
stress hormone levels will not be measured |
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Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |