UMIN-CTR Clinical Trial

Basic information
Public title	Association of 6% hydroxyethyl starch 130/0.4 with acute kidney injury in surgical patients in the postoperative period: a multicenter retrospective study.
Acronym	Association of 6% hydroxyethyl starch 130/0.4 with acute kidney injury in surgical patients
Scientific Title	Association of 6% hydroxyethyl starch 130/0.4 with acute kidney injury in surgical patients in the postoperative period: a multicenter retrospective study.
Scientific Title:Acronym	Association of 6% hydroxyethyl starch 130/0.4 with acute kidney injury in surgical patients
Region	Japan

Condition
Condition	acute kidney injury in surgical patients in the postoperative period
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the association of administration of 6% HES 130/0.4 during surgery with occurrence of acute kidney injury (AKI) in surgical patients in the postoperative period
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Occurrence of AKI in surgical patients in the postoperative period
Key secondary outcomes

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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	All surgical patients
Key exclusion criteria	Patients were excluded if they had severe sepsis, pulmonary edema, congestive heart failure, severe chronic kidney disease (CKD) with a decrease in preoperative estimated glomerular filtration rate (pre eGFR) to <44 mL/min/1.73mm2, intracranial bleeding, hypernatremia or hyperchloremia; had undergone cardiac surgery required for cardiopulmonary bypass; or had a lack of perioperative data.
Target sample size	6000

Research contact person
Name of lead principal investigator	1st name Middle name Last name Michiaki Yamakage
Organization	Sapporo Medical University School of Medicine
Division name	Anesthesiology
Zip code
Address	South 1 West 16 Chu-o-ku Sapporo, Hokkaido
TEL	0116112111
Email	yamakage@sapmed.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Atsushi Sawada
Organization	Sapporo Medical University School of Medicine
Division name	Anesthesiology
Zip code
Address	South 1 West 16 Chu-o-ku Sapporo, Hokkaido
TEL	0116112111
Homepage URL
Email	atusihon618@yahoo.co.jp

Sponsor
Institute	Sapporo Medical University School of Medicine
Institute
Department

Funding Source
Organization	Sapporo Medical University School of Medicine
Organization
Division
Category of Funding Organization	Self funding
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	2017 Year 11 Month 14 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	Terminated
Date of protocol fixation	2017 Year 11 Month 14 Day
Date of IRB	2016 Year 11 Month 14 Day
Anticipated trial start date	2017 Year 11 Month 14 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

We retrospectively investigate the patients and collected data from electronic anesthetic records for volume of HES 130/0.4, crystalloid solutions, albumin products, red blood cell product (RBC), fresh frozen plasma (FFP), platelet product (Plt), blood loss during surgery, age, gender, height, body weight, preoperative creatinine value (pre Cr), pre eGFR, postoperative creatinine value (post Cr), anesthetic time, and operation time.

Management information
Registered date	2017 Year 03 Month 14 Day
Last modified on	2019 Year 09 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030484