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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027895
Receipt No. 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

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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 Obsterics 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
Email 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
Email kamoshitas@otsuka.jp

Sponsor
Institute Otsuka Pharmaceutical Factory, Inc.
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031957

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name
2018/03/20 解析結果.lzh


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