UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026545 |
|---|---|
| Receipt number | R000030484 |
| Scientific Title | Association of 6% hydroxyethyl starch 130/0.4 with acute kidney injury in surgical patients in the postoperative period: a multicenter retrospective study. |
| Date of disclosure of the study information | 2017/11/14 |
| Last modified on | 2019/09/29 10:32:26 |
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Basic information
Public title
Association of 6% hydroxyethyl starch 130/0.4 with acute kidney injury in surgical patients in the postoperative period: a multicenter retrospective study.
Acronym
Association of 6% hydroxyethyl starch 130/0.4 with acute kidney injury in surgical patients
Scientific Title
Association of 6% hydroxyethyl starch 130/0.4 with acute kidney injury in surgical patients in the postoperative period: a multicenter retrospective study.
Scientific Title:Acronym
Association of 6% hydroxyethyl starch 130/0.4 with acute kidney injury in surgical patients
Region
| Japan |
Condition
Condition
acute kidney injury in surgical patients in the postoperative period
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the association of administration of 6% HES 130/0.4 during surgery with occurrence of acute kidney injury (AKI) in surgical patients in the postoperative period
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Occurrence of AKI in surgical patients in the postoperative period
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All surgical patients
Key exclusion criteria
Patients were excluded if they had severe sepsis, pulmonary edema, congestive heart failure, severe chronic kidney disease (CKD) with a decrease in preoperative estimated glomerular filtration rate (pre eGFR) to <44 mL/min/1.73mm2, intracranial bleeding, hypernatremia or hyperchloremia; had undergone cardiac surgery required for cardiopulmonary bypass; or had a lack of perioperative data.
Target sample size
6000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Michiaki Yamakage |
Organization
Sapporo Medical University School of Medicine
Division name
Anesthesiology
Zip code
Address
South 1 West 16 Chu-o-ku Sapporo, Hokkaido
TEL
0116112111
yamakage@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Atsushi Sawada |
Organization
Sapporo Medical University School of Medicine
Division name
Anesthesiology
Zip code
Address
South 1 West 16 Chu-o-ku Sapporo, Hokkaido
TEL
0116112111
Homepage URL
atusihon618@yahoo.co.jp
Sponsor or person
Institute
Sapporo Medical University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Sapporo Medical University School of Medicine
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
Address
Tel
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
| 2017 | Year | 11 | Month | 14 | 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
Terminated
Date of protocol fixation
| 2017 | Year | 11 | Month | 14 | Day |
Date of IRB
| 2016 | Year | 11 | Month | 14 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 14 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We retrospectively investigate the patients and collected data from electronic anesthetic records for volume of HES 130/0.4, crystalloid solutions, albumin products, red blood cell product (RBC), fresh frozen plasma (FFP), platelet product (Plt), blood loss during surgery, age, gender, height, body weight, preoperative creatinine value (pre Cr), pre eGFR, postoperative creatinine value (post Cr), anesthetic time, and operation time.
Management information
Registered date
| 2017 | Year | 03 | Month | 14 | Day |
Last modified on
| 2019 | Year | 09 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030484
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
