UMIN-CTR Clinical Trial

Basic information
Public title	Hyperlactatemia is an indicator of acute kidney injury in adult cardiac surgery with cardiopulmonary bypass.
Acronym	Hyperlactatemia is an indicator of acute kidney injury in adult cardiac surgery with cardiopulmonary bypass.
Scientific Title	The relationship between hyperlactatemia and acute kidney injury in adult cardiac surgery with cardiopulmonary bypass. A single-centre backwards-looking study
Scientific Title:Acronym	The relationship between hyperlactatemia and acute kidney injury in adult cardiac surgery with cardiopulmonary bypass. A single-centre backwards-looking study
Region	Japan

Condition
Condition	Cardiac disease
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Clarifying the association between hyperlactatemia and AKI in adults after cardiopulmonary bypass and its usefulness for clinical diagnosis
Basic objectives2	Others
Basic objectives -Others	Prognostic value
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Onset of acute kidney injury
Key secondary outcomes	ICU length of stay, mortality, P/F ratio, use of pressure-boosting drugs, postoperative hemoglobin level, postoperative hematocrit level, creatinine reduction rate, etc.

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	Not applicable
Gender	Male and Female
Key inclusion criteria	Adult patients undergoing cardiac operations with cardiopulmonary bypass between 1st October 2016 and 14th June 2021
Key exclusion criteria	Emergency surgery, surgery on patients under 18 years of age, patients under total intravenous anaesthesia, patients with end-stage renal failure (GFR <15 mL/min/1.73m2) and dialysis patients, patients with alcoholism, patients on preoperative artificial heart lungs, other unsuitable cases
Target sample size	150

Research contact person
Name of lead principal investigator	1st name Kosuke Middle name Last name Hamada
Organization	Oji General Hospital
Division name	Anesthesiology
Zip code	053-8506
Address	3-4-8 Wakakakusa-cho, Tomakomai City, Hokkaido
TEL	0144328111
Email	hamakou21@hotmail.com

Public contact
Name of contact person	1st name Kosuke Middle name Last name Hamada
Organization	Oji General Hospital
Division name	Anesthesiology
Zip code	053-8506
Address	3-4-8 Wakakakusa-cho, Tomakomai City, Hokkaido
TEL	0144328111
Homepage URL
Email	hamakou21@hotmail.com

Sponsor
Institute	Oji General Hospital
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Oji General Hospital
Address	3-4-8 Wakakakusa-cho, Tomakomai City, Hokkaido
Tel	0144328111
Email	hamakou21@hotmail.com

Secondary IDs
Secondary IDs	YES
Study ID_1	OGH2021-15
Org. issuing International ID_1	Oji General Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2021 Year 06 Month 29 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	2021 Year 05 Month 31 Day
Date of IRB
Anticipated trial start date	2021 Year 06 Month 22 Day
Last follow-up date	2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	The study protocol is disclosed in an opt-out format on the institutional web-site, giving an opportunity to refuse consent. If there is a disagreement application during the investigation period, the relevant data will be deleted.

Management information
Registered date	2021 Year 06 Month 29 Day
Last modified on	2021 Year 06 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050955