UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000008089
Receipt number R000009434
Scientific Title Investigation of risk factors for perioperative acute kidney injury after liver resection surgery
Date of disclosure of the study information 2012/06/05
Last modified on 2012/12/05 10:41:54

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Basic information

Public title

Investigation of risk factors for perioperative acute kidney injury after liver resection surgery

Acronym

Investigation of risk factors for perioperative acute kidney injury after liver resection surgery

Scientific Title

Investigation of risk factors for perioperative acute kidney injury after liver resection surgery

Scientific Title:Acronym

Investigation of risk factors for perioperative acute kidney injury after liver resection surgery

Region

Japan


Condition

Condition

Liver diseases that require liver resection surgery

Classification by specialty

Hepato-biliary-pancreatic surgery Anesthesiology Adult

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To investigate the incidence of postoperative acute kidney injury (AKI), define the risk factors for AKI, and clarify the relationships between AKI and outcome during hospitalization.

Basic objectives2

Others

Basic objectives -Others

epidemiology research

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Risk factors
Incidence rate
Outcome

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients who underwent liver resection surgery

Key exclusion criteria

Hemodialysis dependent patients
Patients who required additional surgery within 72 hours postoperatively

Target sample size

600


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Seiji Ishikawa

Organization

Tokyo Medical and Dental University

Division name

Department of Anesthesiology

Zip code


Address

1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Tokyo Medical and Dental University

Division name

Department of Anesthesiology

Zip code


Address

1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan

TEL


Homepage URL


Email



Sponsor or person

Institute

Tokyo Medical and Dental University

Institute

Department

Personal name



Funding Source

Organization

Tokyo Medical and Dental University

Organization

Division

Category of Funding Organization

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

2012 Year 06 Month 05 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

Completed

Date of protocol fixation

2011 Year 11 Month 30 Day

Date of IRB


Anticipated trial start date

2012 Year 01 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Patients who underwent liver resection surgery from Jan 1, 2004 and Oct 31, 2011 at Tokyo Medical and Dental University Hospital are enrolled. The incidence of postoperative acute kidney injury (AKI) will be calculated and the risk factors will be defined and the relationships between AKI and outcome will be clarified.


Management information

Registered date

2012 Year 06 Month 03 Day

Last modified on

2012 Year 12 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009434


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name