Acute Renal Failure Post Liver Transplantation

Acute Renal Failure Post Liver Transplantation: The Role of Cytokines and Oxidative Stress

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

Study Overview

• Status: Completed
• Conditions: Acute Renal Failure
• Intervention / Treatment: Drug: N-acetylcysteine; Drug: Placebo

Detailed Description

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
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75246
      • Annette C. and Harold C. Simmons Tranplant Institute at Baylor Medical Center Dallas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 71 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 600 mg N-acetylcysteine or placebo IV; 600 mg N-acetylcysteine or placebo IV perfused over 15 minutes during the transplant procedure, prior to reperfusion,	Drug: N-acetylcysteine; drug will be administered via IV,NG; Other Names: NAC; Drug: Placebo; placebo or NAC will be given; Other Names: Placebo in place of NAC
Active Comparator: 600 mg N-acetylcysteine or placebo NG; 600 mg NAC or placebo administered via NG tube starting at 12 hrs + 30 min post O.R. infusion,	Drug: N-acetylcysteine; drug will be administered via IV,NG; Other Names: NAC; Drug: Placebo; placebo or NAC will be given; Other Names: Placebo in place of NAC
Active Comparator: N-acetylcysteine or placebo q 12 hour; 600 mg NAC or placebo administered via NG tube every 12 hrs + 30 min for 3 additional doses (at 24, 36 and 48 hrs post O.R. infusion). The total administration will be 3000 mg over a 48 hr period.	Drug: N-acetylcysteine; drug will be administered via IV,NG; Other Names: NAC; Drug: Placebo; placebo or NAC will be given; Other Names: Placebo in place of NAC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	6 months

Collaborators and Investigators

• Sponsor: Baylor Research Institute
• Investigators: Principal Investigator: Yousri M. Barri, MD, Baylor Health Care System

Study record dates

Study Major Dates

• Study Start: July 1, 2007
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: November 16, 2012
• First Submitted That Met QC Criteria: July 22, 2013
• First Posted (Estimate): July 24, 2013

Study Record Updates

• Last Update Posted (Actual): February 21, 2020
• Last Update Submitted That Met QC Criteria: February 20, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: acute renal failure; post liver transplant
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Acute Kidney Injury; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Protective Agents; Respiratory System Agents; Antioxidants; Antidotes; Free Radical Scavengers; Expectorants; Acetylcysteine; N-monoacetylcystine
• Other Study ID Numbers: 007-157

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO