UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043475 |
|---|---|
| Receipt number | R000049601 |
| Scientific Title | Effect of enterally administered sleep-promoting medication on the intravenous sedative dose and its safety and cost profile in mechanically ventilated patients: a retrospective cohort study |
| Date of disclosure of the study information | 2021/03/01 |
| Last modified on | 2022/07/22 11:37:04 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effect of enterally administered sleep-promoting medication on the intravenous sedative dose and its safety and cost profile in mechanically ventilated patients: a retrospective cohort study
Acronym
Effect of enterally administered sleep-promoting medication on the intravenous sedative dose and its safety and cost profile in mechanically ventilated patients: a retrospective cohort study
Scientific Title
Effect of enterally administered sleep-promoting medication on the intravenous sedative dose and its safety and cost profile in mechanically ventilated patients: a retrospective cohort study
Scientific Title:Acronym
Effect of enterally administered sleep-promoting medication on the intravenous sedative dose and its safety and cost profile in mechanically ventilated patients: a retrospective cohort study
Region
| Japan |
Condition
Condition
critical ill patients
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study the relationship between changes in enteral doses of sleep-promoting medication and intravenous doses of sedatives and prognosis in patients intubated and undergoing ventilatory management.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The average daily propofol dose per body weight administered as a continuous sedative during mechanical ventilation through an oral endotracheal tube.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 15 | years-old | <= |
Age-upper limit
| 120 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Having started mechanical ventilation within 24 hours of ICU admission
Requiring mechanical ventilation using an oral endotracheal tube for at least 48 hours
Key exclusion criteria
central nervous system disease (stroke, epilepsy, meningitis, encephalitis, etc.), cardiopulmonary arrest, traumatic brain injury, overdose, gastrointestinal tract impracticability (administration of continuous neuromuscular blockade, abdominal surgery, ileus, gastrointestinal bleeding, etc.), previous psychiatric or cognitive pathology, Child C hepatopathy, pregnancy, previous tracheostomy, ICU readmission, lacking body weight records, death in ICU, and not receiving propofol.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Takefumi |
| Middle name | |
| Last name | Tsunemitsu |
Organization
Hyogo Prefectural Amagasaki General Medical Center
Division name
Department of Emergency and Critical Care Medicine
Zip code
660-8550
Address
2-17-77 Higashinaniwa-cho, Amagasaki, Hyogo
TEL
06-6480-7000
tsunemitsu0730@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Takefumi |
| Middle name | |
| Last name | Tsunemitsu |
Organization
Hyogo Prefectural Amagasaki General Medical Center
Division name
Department of Emergency and Critical Care Medicine
Zip code
660-8550
Address
2-17-77 Higashinaniwa-cho, Amagasaki, Hyogo
TEL
06-6480-7000
Homepage URL
tsunemitsu0730@yahoo.co.jp
Sponsor or person
Institute
Department of Emergency and Critical Care Medicine, Hyogo Prefectural Amagasaki General Medical Center
Institute
Department
Personal name
Funding Source
Organization
Not Applicable
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hyogo Prefectural Amagasaki General Medical Center
Address
2-17-77 Higashinaniwa-cho, Amagasaki, Hyogo
Tel
0664807000
tsunemitsu0730@yahoo.co.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 03 | Month | 01 | Day |
Related information
URL releasing protocol
https://doi.org/10.1371/journal.pone.0261305
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1371/journal.pone.0261305
Number of participants that the trial has enrolled
123
Results
The average daily propofol dose per body weight administered as a continuous sedative during mechanical ventilation through an oral endotracheal tube was significantly lower in the early administration group (EA group) than in the late administration (LA group) and no administration group (NA group) (Beta Coefficient -5.18 [95% CI -8.95 to -1.40], Beta Coefficient -4.51 [95% CI -8.58 to -0.44]); however, there was no difference between the LA and NA groups (Beta Coefficient 0.66 [95% CI -3.14 to 4.46]).
Results date posted
| 2021 | Year | 03 | Month | 01 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The median age of patients of this study was 72 years, 72 % were males, and the median body mass index was 23.1. The SOFA score and Charlson comorbidity index were 6 and 0 in the EA group, 6 and 0 in the LA group, and 7 and 0 in the NA group. Respiratory failure was the most common diagnosis upon ICU admission, especially in the EA group (EA, 22 [60%]; LA, 28 [56%]; NA, 13 [36%]).
Participant flow
We screened 1412 patients and included 123 patients for analysis.
Adverse events
There were no differences between groups in liver damage requiring drug change, ventricular arrhythmia, or unplanned sedative administration. The risk difference of self-extubation were lower in the EA group than in the EA and LA groups (risk difference [RD] -4.00%, p = 0.02; EA vs. NA, RD -5.56%, p = 0.03). Since no patients in the EA group had self-extubation and we could not calculate the odds ratios, self-extubation was assessed through risk difference.
Outcome measures
In a multivariate analysis, the mean daily propofol dose per body weight administered as continuous sedation during ventilation with an oral endotracheal tube was significantly lower in the EA group than in the LA and NA group (beta coefficient -5.13 [95% CI, -8.93 to -1.33]; beta coefficient -4.51 [95% CI, -8.59 to -0.43]).
Multivariate analysis showed no significant differences between groups in duration of mechanical ventilation by oral endotracheal intubation, duration of ICU stay, RASS 2 or more points or delirium.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 25 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We investigated the amount of intravenous sedatives in patients who received mechanical ventilation during the period from July 2015 to January 2020, with and without sleep-promoting drugs.
Pateients were divided into three group in which the sleep-promoting drug was administered within 48 hours after admission, a group in which the drug was administered after 48, and a group in which the drug was not administered.
Management information
Registered date
| 2021 | Year | 03 | Month | 01 | Day |
Last modified on
| 2022 | Year | 07 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049601
