UMIN-CTR Clinical Trial

Basic information
Public title	Impact of perioperative acute dialysis requirement on mortality in major surgeries: A retrospective cohort study
Acronym	Impact of perioperative acute dialysis requirement on mortality in major surgeries: A retrospective cohort study
Scientific Title	Impact of perioperative acute dialysis requirement on mortality in major surgeries: A retrospective cohort study
Scientific Title:Acronym	Impact of perioperative acute dialysis requirement on mortality in major surgeries: A retrospective cohort study
Region	Japan

Condition
Condition	Patients undergoing major surgeries
Classification by specialty	Medicine in general Nephrology Geriatrics Surgery in general Adult
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	This study aimed to determine risks for in-hospital death and functional decline following various surgeries with an acute dialysis requirement versus maintenance dialysis and non-dialysis.
Basic objectives2	Others
Basic objectives -Others	Predictors for clinical outcomes
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	In-hospital death
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	50 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	The study participants were identified from the Diagnosis Procedure Combination (DPC) inpatient database. Inclusion criteria for this study were age 50 years and older, hospitalization 24 hours and longer, and the patient received a major surgery during 2018 and 2019 in Japan.
Key exclusion criteria	We excluded second or later admissions, patients with incomplete information on BMI, ADL, emergency admission, and patients receiving multiple types of surgeries.
Target sample size	850000

Research contact person
Name of lead principal investigator	1st name Shintaro Middle name Last name Mandai
Organization	Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University
Division name	Department of Nephrology
Zip code	113-8519
Address	1-5-45 Yushima, Bunkyo, Tokyo
TEL	0358035214
Email	smandai.kid@tmd.ac.jp

Public contact
Name of contact person	1st name Shintaro Middle name Last name Mandai
Organization	Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University
Division name	Department of Nephrology
Zip code	113-8519
Address	1-5-45 Yushima, Bunkyo, Tokyo
TEL	0358035214
Homepage URL
Email	smandai.kid@tmd.ac.jp

Sponsor
Institute	Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization	The Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Tokyo Medical and Dental University
Address	1-5-45 Yushima, Bunkyo, Tokyo
Tel	1-5-45 Yushima, Bunkyo, Tokyo
Email	NA

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 04 Month 04 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	993633
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	Completed
Date of protocol fixation	2021 Year 08 Month 01 Day
Date of IRB	2021 Year 07 Month 27 Day
Anticipated trial start date	2021 Year 08 Month 01 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry	2022 Year 07 Month 30 Day
Date trial data considered complete	2022 Year 07 Month 30 Day
Date analysis concluded	2022 Year 10 Month 05 Day

Other
Other related information	We analyzed the patients who underwent major surgeries during hospitalization in Japan from 2018 until 2019 using an inpatient administrative claims database. Risks of overall death and functional decline assessed by Barthel index scores were determined with logistic regression models.

Management information
Registered date	2022 Year 04 Month 04 Day
Last modified on	2022 Year 10 Month 05 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054051