Incidence, Risk Factors, and Risk Model of Acute Kidney I... | NCT02080065

Studies
Incidence, Risk Factors, and Risk Model of Acute Kidney Injury After Liver Transplantation

NCT02080065

Sponsor

Samsung Medical Center

Status

Completed

Last Update Posted

Aug 28, 2015Estimated

Enrollment

573Actual

Phase

Not provided

Conditions

Renal Function
Liver Transplantation

Interventions

living donor liver transplantation

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2014

Primary Completion Date

Jun 2015Actual

Completion Date

Jun 2015Actual

First Submitted Date

Mar 4, 2014

First Submission Date that Met QC Criteria

Mar 5, 2014

First Posted Date

Mar 6, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 27, 2015

Last Update Posted Date

Aug 28, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The incidence of acute kidney injury after liver transplantation has been reported to be 17 to 95 percent, but no definite treatment has been reported yet. Therefore, it is important to identify and prevent reversible risk factors for acute kidney injury after liver transplantation. Previous studies have reported several preoperative clinical risk factors, but preoperative medication and intraoperative colloid administration and hemodynamic parameters have not been evaluated. Therefore, we attempt to evaluate perioperative risk factors and develop simplified clinical risk scoring model.

Detailed Description

Ischemia/reperfusion injury occurs during graft harvesting, cold storage, and surgical procedures in liver transplantation. Ischemia/reperfusion injury in liver graft results in major organ damage including kidney, lung and heart as well as graft dysfunction. Graft dysfunction and renal injury after liver transplantation are major clinical issues and are associated with prognosis and low survival rate. The incidence of acute kidney injury after liver transplantation has been reported to be 17 to 95 percent, but no definite treatment has been reported yet. Therefore, it is important to identify and prevent reversible risk factors for acute kidney injury after liver transplantation. Previous studies have reported several preoperative clinical risk factors, but perioperative medication, metabolic variables (albumin, glucose, uric acid), intraoperative colloid administration and hemodynamic parameters have not been evaluated. In addition, a neutrophil-lymphocyte ratio (NLR), which has been reported to be related to systemic inflammation and associated with prognosis of cardiac and cancer patients, might be related to the development of AKI after LDLT. Therefore, we attempt to evaluate these perioperative risk factors and develop simplified clinical risk scoring model.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

573Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
liver transplantation		patients who underwent living donor liver transplantation during between 2007 and 2013	Procedure: living donor liver transplantation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
living donor liver transplantation	Procedure		liver transplantation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
acute kidney injury as defined by RIFLE criteria	acute kidney injury as defined by RIFLE criteria	during 7 days after transplantation

Secondary Outcomes

Measure	Description	Time Frame
incidence of renal replacement therapy	renal replacement therapy	during one month after transplantation
incidence of acute rejection of graft	incidence of acute rejection of graft

Other Outcomes

Measure	Description	Time Frame
Mortality	Mortality during one month, six month, one year	during one month, six month, one year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who underwent living donor liver transplantation between 2010 and 2013 in Samsung Medical Center

Exclusion Criteria:

Incomplete data regarding pre- and postoperative creatinine and estimated Glomerular Filtration Rate
patient who underwent retransplantation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

patients who underwent living donor liver transplantation between 2010 and 2013

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Samsung Medical Center		Seoul		135-710	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D058186	Acute Kidney Injury

Ancestor Terms

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

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Browse Branches

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