UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027895 |
|---|---|
| Receipt number | R000031957 |
| Scientific Title | Association of intraoperative HES130/0.4 and postoperative complications in dialysis-dependent patients :A retrospective cohort study using DPC database |
| Date of disclosure of the study information | 2017/06/30 |
| Last modified on | 2018/12/19 14:38:58 |
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Basic information
Public title
Association of intraoperative HES130/0.4 and postoperative complications in dialysis-dependent patients :A retrospective cohort study using DPC database
Acronym
Association of intraoperative HES130/0.4 and postoperative complications for dialysis-dependent patients.
Scientific Title
Association of intraoperative HES130/0.4 and postoperative complications in dialysis-dependent patients :A retrospective cohort study using DPC database
Scientific Title:Acronym
Association of intraoperative HES130/0.4 and postoperative complications for dialysis-dependent patients.
Region
| Japan |
Condition
Condition
Dialysis-dependent patients who underwent surgery
Classification by specialty
| Surgery in general | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
| Vascular surgery | Chest surgery | Endocrine surgery |
| Breast surgery | Obstetrics and Gynecology | Oto-rhino-laryngology |
| Orthopedics | Urology | Anesthesiology |
| Neurosurgery | Cardiovascular surgery | Operative medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
In dialysis-dependent patients, to investigate the influence of intraoperative HES130/0.4 on postoperative complications, coagulation status, ICU admission, length of postoperative hospital stay, medical expenditure, etc. by comparing the patients who received HES to the patients who did not received HES.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Incidence of postoperative complications
(Myocardial infarction, congestive heart failure, arrhythmia, hypotension, pneumonia, cerebrovascular accident, surgical site infection, postoperative bleeding, sepsis, emergency dialysis (day of surgery), postoperative mortality (within 30 days after surgery) )
Key secondary outcomes
(1)Number of postoperative complications
(2)ICU admission
(3)Length of postoperative hospital stay
(4)Medical expenditure during hospital stay
(5)Blood clotting ability (platelet count, PT-INR, APTT)
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
(1)Dialysis-dependent patients who underwent surgery from January 2014 to December 2016
(2)Patients 18 years or older
(3)Patients who underwent surgery under general anesthesia
Key exclusion criteria
(1)Patients who received dextran or HES70/0.5
(2)Patients who received HES130/0.4 during the period between 7 days before surgery and the day before surgery
(3)Patients who died within 2 days after surgery
(4)Patients who underwent multiple surgeries (during the period of 30 days before and 30 days after surgery)
(5)Patients who received HES130/0.4 only before and/or after surgery on the day of surgery
Target sample size
4000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akiyoshi Kuroda |
Organization
Otsuka Pharmaceutical Factory, Inc.
Division name
Applied Clinical Development Department
Zip code
Address
2-9 Kanda Tsukasamachi, Chiyoda-ku Tokyo
TEL
03-5217-5954
Kuroda.Akiyoshi@otsuka.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoru Kamoshita |
Organization
Otsuka Pharmaceutical Factory, Inc.
Division name
Applied Clinical Development Department
Zip code
Address
2-9 Kanda Tsukasamachi, Chiyoda-ku Tokyo
TEL
03-5217-5954
Homepage URL
kamoshitas@otsuka.jp
Sponsor or person
Institute
Otsuka Pharmaceutical Factory, Inc.
Institute
Department
Personal name
Funding Source
Organization
Otsuka Pharmaceutical Factory, Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Saitama Medical Center, Saitama Medical University
Toho University Ohashi Medical Center
Name of secondary funder(s)
Fresenius Kabi Japan K.K.
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 | 06 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
The incidence of postoperative complications were not significantly different between HES group and non-HES group (49% vs. 51%; RR, 0.96; 95%CI, 0.80-1.16; P=0.70). Number of postoperative complications, ICU admission, length of postoperative hospital stay and medical expenditure were not significantly different between HES group and non-HES group.
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
| 2017 | Year | 06 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2018 | Year | 03 | Month | 16 | Day |
Other
Other related information
Study design:
Retrospective cohort study using the DPC database
Propensity score matching analysis
Data source:
A medical database provided by Medical Data Vision Co. Ltd.
The database is based on the DPC data/pharmacy claims data, and partly includes laboratory data, too. The database covers 16% of all DPC hospitals in Japan. All data is anonymized from the viewpoint of personal information protection.
Study methods:
Among the dialysis-dependent patients who underwent surgery from January 2014 to December 2016, patients who meet the inclusion criteria and exclusion criteria are extracted. The extracted patients are allocated to either of the following two groups; the patients receiving HES130/0.4 and the patients not receiving HES130/0.4.
After propensity score matching, the influence of intraoperative HES130/0.4 on postoperative complications, coagulation status, ICU admission, length of postoperative hospital stay, medical expenditure, etc. is investigated by comparing the patients who received HES130/0.4 to the patients who did not received HES130/0.4.
Management information
Registered date
| 2017 | Year | 06 | Month | 23 | Day |
Last modified on
| 2018 | Year | 12 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031957
