UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014588
Receipt number R000016973
Scientific Title Usefulness of creatinine change rate by the correction value of creatinine as a predictor of acute renal failure in the thoracic and abdominal surgery
Date of disclosure of the study information 2014/07/18
Last modified on 2015/08/20 14:27:46

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Usefulness of creatinine change rate by the correction value of creatinine as a predictor of acute renal failure in the thoracic and abdominal surgery

Acronym

Usefulness of creatinine reduction ratio.

Scientific Title

Usefulness of creatinine change rate by the correction value of creatinine as a predictor of acute renal failure in the thoracic and abdominal surgery

Scientific Title:Acronym

Usefulness of creatinine reduction ratio.

Region

Japan


Condition

Condition

Open heart surgery

Classification by specialty

Surgery in general

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Considered as an indicator of renal failure perioperative rate of change of the Cr value of preoperative and postoperative Cr value, to evaluate the usefulness as a predictor of AKI development.

Basic objectives2

Others

Basic objectives -Others

I diagnosed with acute kidney injury patients with creatinine rose to 1.5-fold increase or 0.3mg/dl or more than the reference value within 48 hours after surgery. Consider about what to make earlier prediction of renal injury by making a correction of creatinine and creatinine moisture balance rate of change, weight change, due to changes in urea nitrogen.

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

Evaluation for usefulness as a predictor of AKI creatinine value rate of change. Create the Area Under the Curve, to determine the reliability of the predictor.

Key secondary outcomes

By correcting the Cr value using fluid balance, weight change, urea nitrogen value of the immediate post-operative (BUN), it should be considered the possibility of early diagnosis of AKI.


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

I include patients who were performed operation as thoracic or abdominal surgery (liver resection, pancreaticoduodenectomy, and esophageal cancer resection).

Key exclusion criteria

Patients under 18 years old are excluded.

Target sample size

400


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shunsuke Takaki

Organization

Yokohama City University Hospital

Division name

Intensive Care Unit

Zip code


Address

3-9 Fukuura Kanazawa Yokohama city Kanagawa prefecture Japan

TEL

0457872800

Email

shunty5323@gmail.com


Public contact

Name of contact person

1st name
Middle name
Last name Shunsuke Takakii

Organization

Yokohama City University Hospital

Division name

Intensive Care Unit

Zip code


Address

3-9 Fukuura Kanazawa Yokohama city Kanagawa prefecture Japan

TEL

0457872800

Homepage URL


Email

shunty5323@gmail.com


Sponsor or person

Institute

Yokohama City University Hospital Department of Anesthesiology

Institute

Department

Personal name



Funding Source

Organization

Yokohama City University Hospital Department of Anesthesiology

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

横浜市立大学附属病院


Other administrative information

Date of disclosure of the study information

2014 Year 07 Month 18 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

Patients who developed AKI were very small sample size, so protocol required to improve.
Therefore, this current research was ceased.

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

2014 Year 06 Month 01 Day

Date of IRB


Anticipated trial start date

2014 Year 06 Month 05 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Whether creatinine reduction ratio associated kidney injury.


Management information

Registered date

2014 Year 07 Month 18 Day

Last modified on

2015 Year 08 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016973


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name