UMIN-CTR Clinical Trial

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

critical ill patients

Classification by specialty

Intensive care medicine

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

Email

tsunemitsu0730@yahoo.co.jp

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

Email

tsunemitsu0730@yahoo.co.jp

Institute

Department of Emergency and Critical Care Medicine, Hyogo Prefectural Amagasaki General Medical Center

Institute

Department

Personal name

Organization

Not Applicable

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Hyogo Prefectural Amagasaki General Medical Center

Address

2-17-77 Higashinaniwa-cho, Amagasaki, Hyogo

Tel

0664807000

Email

tsunemitsu0730@yahoo.co.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2021

Year

03

Month

01

Day

URL releasing protocol

https://doi.org/10.1371/journal.pone.0261305

Publication of results

Published

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

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 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.

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