UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025055 |
|---|---|
| Receipt number | R000028833 |
| Scientific Title | Effect of hydroxyethyl starch 130/0.4 on perioperative renal function in patients undergoing cardiac surgery |
| Date of disclosure of the study information | 2016/11/29 |
| Last modified on | 2016/11/29 20:04:40 |
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Basic information
Public title
Effect of hydroxyethyl starch 130/0.4 on perioperative renal function in patients undergoing cardiac surgery
Acronym
Effect of HES 130/0.4 on renal function in cardiac surgery
Scientific Title
Effect of hydroxyethyl starch 130/0.4 on perioperative renal function in patients undergoing cardiac surgery
Scientific Title:Acronym
Effect of HES 130/0.4 on renal function in cardiac surgery
Region
| Japan |
Condition
Condition
cardiac diseases which require cardiac surgery
Classification by specialty
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigation into the effect of hydroxyethyl starch 130/0.4 on renal function in cardac surgery
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Acute kidney injury within 30days after cardiac surgery
Key secondary outcomes
serum Cystatin C, urine L-FABP, and beta 2 microglobulin in postoperative days
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
administration of bicarbonate riger solution and hydroxyethyl starch 130/0.4 during surgery
Interventions/Control_2
administration of bicarbonate riger solution
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
patients undergoing cardiac surgery requiring cardiopulmonary bypass
Key exclusion criteria
eGFR<45ml/min/1.73m2
urgent surgery
reoperation
anaphylaxis for hydroxyethyl starch
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kei Nagaya |
Organization
Tohoku medical and pharmaceutical university hospital
Division name
division of anesthesia
Zip code
Address
1-12-1 fukumuro, miyagino-ku, sendai, miyagi
TEL
022-259-1221
k-nagaya@hosp.tohoku-mpu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sadao Hatanaka |
Organization
Tohoku medical and pharmaceutical university hospital
Division name
Tikenn Center
Zip code
Address
1-12-1 fukumuro, miyagino-ku, sendai, miyagi
TEL
022-259-1221
Homepage URL
tikenn@hosp.tohoku-mpu.ac.jp
Sponsor or person
Institute
Tohoku medical and pharmaceutical university hospital
Institute
Department
Personal name
Funding Source
Organization
Tohoku medical and pharmaceutical university hospital
Organization
Division
Category of Funding Organization
Other
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
| 2016 | Year | 11 | 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
Completed
Date of protocol fixation
| 2014 | Year | 03 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 04 | Month | 07 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 11 | Month | 29 | Day |
Last modified on
| 2016 | Year | 11 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028833
