Acute Renal Failure Post Liver Transplantation

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Baylor Research Institute
ClinicalTrials.gov Identifier:
NCT01907061
First received: November 16, 2012
Last updated: March 4, 2014
Last verified: March 2014
  Purpose

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


Condition Intervention
Acute Renal Failure
Drug: N-acetylcysteine
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Acute Renal Failure Post Liver Transplantation: The Role of Cytokines and Oxidative Stress

Resource links provided by NLM:


Further study details as provided by Baylor Research Institute:

Primary Outcome Measures:
  • To determine levels of pro-inflammatory cytokines and oxidative stress markers in liver transplant patients during post-transplant period [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Cytokines in patients receiving N-acetylcysteine versus those receiving placebo during liver transplantation will be compared.


Secondary Outcome Measures:
  • To correlate changes in pro-inflammatory cytokines and markers of oxidative stress to acute renal failure and acute rejection [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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

  • 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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 20
Study Start Date: July 2007
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: NAC
Drug: Placebo
placebo or NAC will be given
Other Name: 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 Name: NAC
Drug: Placebo
placebo or NAC will be given
Other Name: 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 Name: NAC
Drug: Placebo
placebo or NAC will be given
Other Name: Placebo in place of NAC

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
  Eligibility

Ages Eligible for Study:   18 Years to 71 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01907061

Locations
United States, Texas
Annette C. and Harold C. Simmons Tranplant Institute at Baylor Medical Center Dallas
Dallas, Texas, United States, 75246
Sponsors and Collaborators
Baylor Research Institute
Investigators
Principal Investigator: Yousri M. Barri, MD Baylor Health Care System
  More Information

No publications provided

Responsible Party: Baylor Research Institute
ClinicalTrials.gov Identifier: NCT01907061     History of Changes
Other Study ID Numbers: 007-157
Study First Received: November 16, 2012
Last Updated: March 4, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Baylor Research Institute:
acute renal failure
post liver transplant

Additional relevant MeSH terms:
Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Acetylcysteine
N-monoacetylcystine
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes

ClinicalTrials.gov processed this record on August 28, 2014