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Completed

NCT Number: NCT01907061

Acute Renal Failure Post Liver Transplantation

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

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Key information

Conditions

Acute Renal Failure Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year–71 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Dallas, Texas, 75246, United States

About this study

  • To determine levels of pro-inflammatory cytokines and oxidative stress markers in liver transplant patients during post-transplant period
  • To correlate changes in pro-inflammatory cytokines and markers of oxidative stress to acute renal failure and acute rejection
  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

N-acetylcysteine

Drug

drug will be administered via IV,NG

Other names: NAC

Placebo

Drug

placebo or NAC will be given

Other names: Placebo in place of NAC

Primary outcomes

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

    Time frame: 6 months

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

Secondary outcomes

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

    Time frame: 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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Baylor Research Institute

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2014
Study completion
2014
First posted
Jul 24, 2013
Registry last updated
Feb 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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