UMIN-CTR Clinical Trial

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

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	Obstetrics and Gynecology	Oto-rhino-laryngology
Orthopedics	Urology	Anesthesiology
Neurosurgery	Cardiovascular surgery	Operative medicine

Classification by malignancy

Malignancy

Genomic information

NO

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

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)

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Otsuka Pharmaceutical Factory, Inc.

Institute

Department

Personal name

Organization

Otsuka Pharmaceutical Factory, Inc.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan

Co-sponsor

Saitama Medical Center, Saitama Medical University
Toho University Ohashi Medical Center

Name of secondary funder(s)

Fresenius Kabi Japan K.K.

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2017

Year

06

Month

30

Day

URL releasing protocol

Publication of results

Published

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

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 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.

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=R000031963