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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025055
Receipt No. 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

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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
Email 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
Email tikenn@hosp.tohoku-mpu.ac.jp

Sponsor
Institute Tohoku medical and pharmaceutical university hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028833

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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