UMIN-ICDS Clinical Trial

Public title

Study of protocolized lighter sedation during open abdomen management

Acronym

Study of protocolized lighter sedation during open abdomen management

Scientific Title

Study of protocolized lighter sedation during open abdomen management

Scientific Title:Acronym

Study of protocolized lighter sedation during open abdomen management

Region

Japan

Condition

acute abdomen

Classification by specialty

Emergency medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

In April 2020, our ICU introduced a sedation protocol that maintains shallow sedation during open abdominal management (OAM). We will determine whether the shallow sedation protocol has reduced the amount of sedation medications used, shortened the duration of ventilator management, and whether shallow sedation raises safety concerns such as increased bleeding and bowel evacuation.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

The co-primary outcomes were time spent under light sedation (Richmond Agitation and Sedation Scale [RASS] -2 to 0) during OAM, and propofol dosage (mg/kg/hr) during OAM.

Key secondary outcomes

Secondary outcomes included analgesics and sedatives exposure other than propofol, time from abdominal closure to weaning from mechanical ventilation, length of ICU stay, length of hospital stay, in-hospital mortality, tracheotomy performed during ICU stay, days spent under coma (defined as -4 or -5 of RASS throughout the day) during OAM, delirium (defined as at least one positive Confusion Assessment Method for the Intensive Care Unit [CAM-ICU]) during OAM, vasopressor administration during ICU stay, and kidney replacement therapy during ICU stay. We also evaluated adverse events during OAM, defined as bleeding or disruption of abdominal dressings requiring urgent intra-abdominal observation and dressing replacement.

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

18

years-old

<=

Age-upper limit

120

years-old

>=

Gender

Male and Female

Key inclusion criteria

Adult patient admitted to ICU with OAM after surgery for acute abdomen due to endogenous disease

Key exclusion criteria

Patients with abdominal compartment syndrome, patients receiving continuous muscle relaxants

Target sample size

80

Name of lead principal investigator

1st name	Junichi
Middle name
Last name	Fukushima

Organization

Wakayama Medical University

Division name

Department of Emergency and Critical Care Medicine

Zip code

641-8509

Address

811-1 Kimiidera, Wakayama, Wakayama Prefecture 641-8509, Japan

TEL

073-447-2300

Email

ow.junichi.1125@gmail.com

Name of contact person

1st name	Junichi
Middle name
Last name	Fukushima

Organization

Wakayama Medical University

Division name

Department of Emergency and Critical Care Medicine

Zip code

641-8509

Address

811-1 Kimiidera, Wakayama, Wakayama Prefecture 641-8509, Japan

TEL

073-447-2300

Homepage URL

Email

ow.junichi.1125@gmail.com

Institute

Wakayama Medical University

Institute

Department

Personal name

Junichi Fukushima

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Research Ethics Committee of Wakayama Medical University

Address

811-1 Kimiidera, Wakayama, Wakayama Prefecture 641-8509, Japan

Tel

073-447-2300

Email

wa-rinri@wakayama-med.ac.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

2024

Year

02

Month

21

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Preinitiation

Date of protocol fixation

2023

Year

12

Month

20

Day

Date of IRB

2023

Year

12

Month

20

Day

Anticipated trial start date

2024

Year

03

Month

01

Day

Last follow-up date

2026

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Patients admitted to the ICU with OAM after surgery for endogenous acute abdomen from April 2018 to March 2022 will be included. Cases of abdominal compartment syndrome and continuous muscle relaxants will be excluded.
Patient background (age, dementia, institutionalization, etc.), information at admission (disease title, severity score, etc.), and information during hospitalization (length of stay, outcome, OAM management time, RASS score during OAM, amount of drugs used, etc.) will be collected from medical records.
Patients will be divided into two groups and compared before and after initiation of the OAM sedation protocol; primary outcome will be the percentage of time patients were able to maintain shallow sedation during OAM and the amount of propofol used per weight during OAM. Other exploratory analyses will be conducted as this is a retrospective observational study.

Registered date

2024

Year

02

Month

21

Day

Last modified on

2024

Year

04

Month

27

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061015