Acute Renal Failure Post Liver Transplantation

N/ACompletedNCT01907061

Baylor Research Institute30 enrolled

Overview

Trial to test the effect of administering N-acetylcysteine on cytokines and markers of oxidant stress and the incidence of acute renal failure post liver tranplant

1. To determine levels of pro-inflammatory cytokines and oxidative stress markers in liver transplant patients during post-transplant period 2. To correlate changes in pro-inflammatory cytokines and markers of oxidative stress to acute renal failure and acute rejection 3. To determine the impact of using N-acetylcysteine on cytokines and markers of oxidative stress and the incidence of acute renal failure post liver transplantation

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Acute Renal Failure

Interventions

N-acetylcysteineDRUG

drug will be administered via IV,NG

PlaceboDRUG

placebo or NAC will be given

Eligibility

Sex: ALLMin age: 18 YearsMax age: 71 Years

Medical Language ↔ Plain English

Inclusion Criteria: * First liver transplant * Normal renal function before transplantation \[serum creatinine ≤ 1.5 mg / dl\] * No requirements for dialysis before transplantation * Age greater than 18 years Exclusion Criteria: * Re-transplant * Renal dysfunction i.e. serum creatinine \> 1.5 mg/dl * Need for dialysis before transplantation * Presence of Hepatorenal or Hepatopulmonary syndrome\* * Combined liver and kidney transplant * Peptic ulcer disease * Pregnancy

Locations (1)

Annette C. and Harold C. Simmons Tranplant Institute at Baylor Medical Center Dallas

Dallas, Texas, United States

Outcomes

Primary Outcomes

To determine levels of pro-inflammatory cytokines and oxidative stress markers in liver transplant patients during post-transplant period

Cytokines in patients receiving N-acetylcysteine versus those receiving placebo during liver transplantation will be compared.

Time frame: 6 months

Secondary Outcomes

To correlate changes in pro-inflammatory cytokines and markers of oxidative stress to acute renal failure and acute rejection

F2-isoprostanes levels in the two groups will be compared to evaluate the role in acute renal failure and acute rejection in patients recieving a liver transplant

Time frame: 6 months

iTo determine the impact of using N-acetylcysteine on cytokines and markers of oxidative stress and the incidence of acute renal failure post liver transplantation

N-acetylcysteine or placebo will be given to patients recieving a liver tranplant cytokines and oxidative stress markers will be compared between the two groups to determine if N-acetylcysteine will impact acute renal failure post liver transplantation

Time frame: 6 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.