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Acute Renal Failure Post Liver Transplantation

Sponsor
Baylor Research Institute (Other)
Overall Status
Completed
CT.gov ID
NCT01907061
Collaborator
(none)
30
Enrollment
1
Location
3
Arms
84
Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Acute Renal Failure Post Liver Transplantation: The Role of Cytokines and Oxidative Stress
Study Start Date :
Jul 1, 2007
Actual Primary Completion Date :
Jul 1, 2014
Actual Study Completion Date :
Jul 1, 2014

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. To determine levels of pro-inflammatory cytokines and oxidative stress markers in liver transplant patients during post-transplant period [6 months]

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

    Secondary Outcome Measures

    1. To correlate changes in pro-inflammatory cytokines and markers of oxidative stress to acute renal failure and acute rejection [6 months]

      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

    2. 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 [6 months]

      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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 71 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Baylor Research Institute
    ClinicalTrials.gov Identifier:
    NCT01907061
    Other Study ID Numbers:
    • 007-157
    First Posted:
    Jul 24, 2013
    Last Update Posted:
    Feb 21, 2020
    Last Verified:
    Feb 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Baylor Research Institute
    acute renal failure
    post liver transplant
    Additional relevant MeSH terms:
    Renal Insufficiency
    Acute Kidney Injury
    Acetylcysteine
    N-monoacetylcystine

    Study Results

    No Results Posted as of Feb 21, 2020