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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027896
Receipt No. R000031963
Scientific Title Effects of intraoperative HES130/0.4 on postoperative kidney function :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 Effects of intraoperative HES130/0.4 on postoperative kidney function :A retrospective cohort study using DPC database.
Acronym Effects of HES130/0.4 on postoperative kidney function
Scientific Title Effects of intraoperative HES130/0.4 on postoperative kidney function :A retrospective cohort study using DPC database.
Scientific Title:Acronym Effects of HES130/0.4 on postoperative kidney function
Region
Japan

Condition
Condition Patients who underwent surgery under general anesthesia or regional anesthesia
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 To investigate the influence of intraoperative HES130/0.4 on postoperative acute kidney injury, renal replacement therapy, volume of blood products, operative mortality, length of postoperative hospital stay, etc. by comparing the patients who received HES to the patients who did not received HES or to the patients who received albumin.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Incidence of postoperative acute kidney injury
Key secondary outcomes (1)Incidence of each stage of KDIGO acute kidney injury classification after surgery
(2)Percentage of patients receiving renal replacement therapy (within 21 days after surgery)
(3)Duration of postoperative renal replacement therapy
(4)Postoperative 30 day mortality
(5)Length of postoperative hospital stay
(6)Kidney function for the patients developing postoperative acute kidney injury (90 days after surgery)
(7)Volume of administered IV solution (day of surgery)
(8)Use of vasopressor (day of surgery)
(9)Volume of blood products (day of surgery)
(10)Coagulation status (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)Patients who underwent surgery under general anesthesia or regional anesthesia from January 2014 to December 2016
(2)Patients 18 years or older
(3)Patients with serum creatinine data within 30 days before surgery and within 7 days after surgery
Key exclusion criteria (1)Patients who underwent dialysis treatment or end stage kidney disease (eGFR<15mL/min/1.73m2) before surgery
(2)Patients who received dextran or HES70/0.5
(3)Patients who received HES130/0.4 or albumin or blood products during the period between 7 days before surgery and the day of surgery
(4)Patients who died within 2 days after surgery
(5)Patients who underwent multiple surgeries (during the period of 30 days before and 30 days after the surgery)
(6)Patients who received HES130/0.4 only before and/or after surgery on the day of surgery
Target sample size 50000

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 any stages of postoperative acute kidney injury (AKI) was not different between HES group and non-HES group (6.2% vs. 5.5%; RR, 1.123; 95%CI, 0.999-1.263; P=0.053). The number of patients who required postoperative renal replacement therapy was significantly smaller in HES group than in non-HES group (0.2% vs. 0.4%; RR, 0.50; 95%CI, 0.28-0.90; P=0.02). The length of postoperative hospital stay was longer in HES group but 30-day mortality was not statistically different.
The incidence of any stages of AKI was significantly lower in HES/non-Alb group than Alb/non-HES group. The patients in HES/non-Alb group had significantly shorter length of hospital stay and significantly low 30-day mortality than the patients in Alb/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 patients who underwent surgery under general anesthesia or regional anesthesia 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 groups.

(1)HES group (the patients receiving HES130/0.4) and non-HES group (the patients not receiving HES130/0.4 )
(2)HES group (the patients receiving HES130/0.4 and not receiving albumin) and Albumin group (the patients receiving albumin and not receiving HES130/0.4).

After propensity score matching, the influence of intraoperative HES 130/0.4 on postoperative acute kidney injury, renal replacement therapy, coagulation function, operative mortality, length of postoperative hospital stay, etc. is investigated by comparing (1) HES group to non-HES group and (2) HES group to Albumin group.

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=R000031963

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name
2018/04/02 解析結果.zip


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