Clinical Trial Results:
A COMPARISON OF DEXMEDETOMIDINE VS PLACEBO AFFECT ON SLEEP-QUALLITY IN MECHANICAL VENTILATED CRITICAL ILL PATIENTS
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Summary
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EudraCT number |
2017-001612-11 |
Trial protocol |
DK |
Global end of trial date |
23 Jun 2022
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Results information
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Results version number |
v1(current) |
This version publication date |
30 Apr 2023
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First version publication date |
30 Apr 2023
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Other versions |
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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 |
3005032
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Rigshospital
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Sponsor organisation address |
Blegdamsvej 9, Copenhagen, Denmark, 2100
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Public contact |
Poul Jennum, Region Hovedstaden, +45 38632512, poul.jennum@regionh.dk
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Scientific contact |
Poul Jennum, Region Hovedstaden, +45 38632512, poul.jennum@regionh.dk
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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 |
01 Apr 2022
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
30 Apr 2020
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Global end of trial reached? |
Yes
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Global end of trial date |
23 Jun 2022
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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 |
Does dexmedetomidine improve deep sleep/sleep quality compared to placebo.
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Protection of trial subjects |
The study protocol was published by the British Medical Journal
Open (BMJ Open)36 and was approved by the National Committee
on Health Research Ethics (Approval number: S-20180214). Registration
with EudraCT (European Union Drug Regulating Authorities
Clinical Trials Database) registration number: 2017–001612-11DK
(October 27, 2017. URL: https://www.clinicaltrialsregister.eu/ctrsearch/
trial/2017-001612-11/DK) was performed, upon approval
from the Danish Medicines Agency. Monitoring was performed by
Good Clinical Practice (GCP). Registration with the Danish Data Protection
Agency was done, and all data collected were stored online
using REDCap, which complies with international confidentiality and
GCP guidelines.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Nov 2017
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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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 |
Denmark: 30
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Worldwide total number of subjects |
30
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EEA total number of subjects |
30
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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) |
6
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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 mechanically ventilated patient was screened from 8 a.m. to 4 p.m. every day during the study period and candidates fulfilling the inclusion and exclusion criteria were found using clinical observation and the hospital medical record. Patients that were eligible for inclusion were contacted by the investigator (MD) and informed written and | |||||||||
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Pre-assignment
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Screening details |
Inclusion criteria: admission to the ICU. 18 years old or over. Anticipated stay in the ICU for another day after the first sleep recording. Mechanically ventilated patients. Hemodynamically stable patients. Acceptable PSG recording during the first night. Conscious non-sedated patients with the Danish language. Exclusion criteria: SOFA score | |||||||||
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Period 1
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Period 1 title |
Baseline (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 |
Subject, Investigator, Data analyst, Carer, Assessor | |||||||||
Blinding implementation details |
Neither the electronic treatment code, randomization envelopes nor the
study drug was accessible to the investigators, nor anyone employed in
the ICU. No contact with the pharmacy personnel preparing the study
drug was allowed at any time. Only the data manager and the GCP monitor
had access to the randomization code. Sleep assessments were done
randomly by an independent doctor having only the randomization code
for identification, thus blinded to treatment and the order of the recordings
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Dexmedetomidine | |||||||||
Arm description |
DEX | |||||||||
Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
Dexmedetomidine
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Concentrate and solvent for suspension for injection
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Routes of administration |
Infusion
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Dosage and administration details |
4 μg/mL iv. infusion
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Arm title
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placebo | |||||||||
Arm description |
placebo | |||||||||
Arm type |
Placebo | |||||||||
Investigational medicinal product name |
Glucose 5%in
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solvent for...
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Routes of administration |
Infusion
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Dosage and administration details |
4 μg/mL infusion as with intervention drug
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End points reporting groups
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Reporting group title |
Dexmedetomidine
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Reporting group description |
DEX | ||
Reporting group title |
placebo
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Reporting group description |
placebo | ||
Subject analysis set title |
Intervention
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
Dex treatedd
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Subject analysis set title |
placebo treated
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
Placebo treated
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End point title |
Sleep quantity [1] | |||||||||
End point description |
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End point type |
Primary
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End point timeframe |
3 days for each patient
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: The data distribution has been tested for skewness, kurtosis, and standard deviation. T-test has been used in the case of normally distributed data and the Wilcoxon-rank-sum test, for non-parametric data. Linear regression has been used to determine correlations between the outcome and clinically relevant variables: days from admission (not equalized between groups), gender, age, BMI, APACHE-II (acute physiology and chronic health evaluation), SAPS3 (simplified acute physiologic score), S |
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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 |
From May 2018 to June 2020
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Adverse event reporting additional description |
none
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Assessment type |
Systematic | ||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||
Dictionary version |
1
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| Frequency threshold for reporting non-serious adverse events: 1% | |||
| 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 was no SAE |
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
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. | |||
| To facilitate sleep classification using the standard criteria is not optimal. These criteria have not been developed for critically ill patients who often present atypical sleep patterns in some studies called Watson to sleep or electroencephalog | |||
