UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044694 |
|---|---|
| Receipt number | R000050955 |
| Scientific Title | The relationship between hyperlactatemia and acute kidney injury in adult cardiac surgery with cardiopulmonary bypass. A single-centre backwards-looking study |
| Date of disclosure of the study information | 2021/06/29 |
| Last modified on | 2021/06/29 16:07:58 |
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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
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
hamakou21@hotmail.com
Sponsor or person
Institute
Oji General Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050955
