UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053669 |
|---|---|
| Receipt number | R000061015 |
| Scientific Title | Study of protocolized lighter sedation during open abdomen management |
| Date of disclosure of the study information | 2024/02/21 |
| Last modified on | 2024/04/27 23:34:24 |
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Basic information
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
Condition
acute abdomen
Classification by specialty
| Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Assessment
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.
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
| 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
Research contact person
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
ow.junichi.1125@gmail.com
Public contact
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
ow.junichi.1125@gmail.com
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
Junichi Fukushima
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee of Wakayama Medical University
Address
811-1 Kimiidera, Wakayama, Wakayama Prefecture 641-8509, Japan
Tel
073-447-2300
wa-rinri@wakayama-med.ac.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
| 2024 | Year | 02 | Month | 21 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
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
Progress
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
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.
Management information
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/ctr_e/ctr_view.cgi?recptno=R000061015
