UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049599 |
|---|---|
| Receipt number | R000056235 |
| Scientific Title | Risk Factors in Scheduled Surgical Patients with Unscheduled Postoperative ICU Admission |
| Date of disclosure of the study information | 2022/11/25 |
| Last modified on | 2024/11/25 10:18:38 |
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Basic information
Public title
Risk Factors in Scheduled Surgical Patients with Unscheduled Postoperative ICU Admission
Acronym
Risk Factors in Scheduled Surgical Patients with Unscheduled Postoperative ICU Admission
Scientific Title
Risk Factors in Scheduled Surgical Patients with Unscheduled Postoperative ICU Admission
Scientific Title:Acronym
Risk Factors in Scheduled Surgical Patients with Unscheduled Postoperative ICU Admission
Region
| Japan |
Condition
Condition
Unscheduled postoperative ICU admission
Classification by specialty
| Anesthesiology | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In the perioperative period, most of the patients scheduled for standby surgery are treated in the general ward without being admitted to the ICU, but for some reason, some patients are admitted to the ICU and require intensive care. In this study, we will compare patients who enter the ICU directly with those who enter the ICU after returning to the general ward and investigate their prognosis and risk factors to see if we can improve the prognosis of postoperative patients who enter the ICU unscheduledly after their scheduled surgery.
Basic objectives2
Others
Basic objectives -Others
Consider whether it is useful to enter the ICU directly unscheduled for any reason during the procedure in a standby scheduled surgery
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Mortality at 3 months
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients undergoing standby scheduled surgery who had an unexpected ICU admission within 7 days of surgery.
Key exclusion criteria
Patients discharged prior to postoperative ICU admission.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | osamu |
| Middle name | |
| Last name | umegaki |
Organization
Osaka Medical and Pharmaceutical University Hospital
Division name
Intensive treatment Department
Zip code
569-8686
Address
2-7 Daigaku block, Takatsuki-city, Osaka
TEL
072-683-1221
osamu.umegaki@ompu.ac.jp
Public contact
Name of contact person
| 1st name | hiroyuki |
| Middle name | |
| Last name | yamazaki |
Organization
Osaka Medical and Pharmaceutical University Hospital
Division name
Intensive treatment Department
Zip code
569-8686
Address
2-7 Daigaku block, Takatsuki-city, Osaka
TEL
072-683-1221
Homepage URL
hiroyuki.yamazaki@ompu.ac.jp
Sponsor or person
Institute
Osaka Medical and Pharmaceutical University Hospital
Institute
Department
Personal name
Funding Source
Organization
Osaka Medical and Pharmaceutical University Hospital
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
Osaka Medical and Pharmaceutical University
Address
2-7 Daigaku block, Takatsuki-city, Osaka
Tel
072-683-1221
rinri@ompu.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
| 2022 | Year | 11 | Month | 25 | 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
| 2022 | Year | 08 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 11 | Month | 25 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2029 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2029 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2029 | Year | 12 | Month | 31 | Day |
Other
Other related information
We will compare patients who are admitted directly to the ICU with those who are admitted to the ICU after returning to the general ward after scheduled surgery and investigate their prognosis and risk factors to see if we can improve the prognosis of postoperative patients who have an unscheduled admission to the ICU.
Management information
Registered date
| 2022 | Year | 11 | Month | 24 | Day |
Last modified on
| 2024 | Year | 11 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056235
