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

Liver Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02080065
• Other study ID #: 2013-12-080
• Status: Completed
• Phase: N/A
• First received: March 4, 2014
• Last updated: August 27, 2015
• Start date: January 2014
• Est. completion date: June 2015

Study information

• Verified date: August 2015
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 573
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Acute Kidney Injury
• Liver Transplantation
• Renal Function

Intervention

Procedure:
• living donor liver transplantation

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mortality	Mortality during one month, six month, one year	during one month, six month, one year	Yes
Primary	acute kidney injury as defined by RIFLE criteria	acute kidney injury as defined by RIFLE criteria	during 7 days after transplantation	Yes
Secondary	incidence of renal replacement therapy	renal replacement therapy	during one month after transplantation	Yes
Secondary	incidence of acute rejection of graft	incidence of acute rejection of graft	during one month after transplantation	Yes
Secondary	incidence of initial poor graft function	incidence of initial poor graft function	during one month after transplantation	Yes
Secondary	incidence of retransplantation	incidence of retransplantation	during one month after transplantation	Yes