Acute Renal Failure Post Liver Transplantation

Study Overview
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Brief Summary
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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

Detailed Description
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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

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

Conditions
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Acute Renal Failure

Intervention / Treatment
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* Drug: N-acetylcysteine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 71 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 600 mg N-acetylcysteine or placebo IV<br>600 mg N-acetylcysteine or placebo IV perfused over 15 minutes during the transplant procedure, prior to reperfusion, | Drug: N-acetylcysteine<br>* drug will be administered via IV,NG<br>* Other names: NAC;Drug: Placebo<br>* placebo or NAC will be given<br>* Other names: Placebo in place of NAC;|
| Active Comparator: 600 mg N-acetylcysteine or placebo NG<br>600 mg NAC or placebo administered via NG tube starting at 12 hrs + 30 min post O.R. infusion, | Drug: N-acetylcysteine<br>* drug will be administered via IV,NG<br>* Other names: NAC;Drug: Placebo<br>* placebo or NAC will be given<br>* Other names: Placebo in place of NAC;|
| Active Comparator: N-acetylcysteine or placebo q 12 hour<br>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<br>* drug will be administered via IV,NG<br>* Other names: NAC;Drug: Placebo<br>* placebo or NAC will be given<br>* Other names: Placebo in place of NAC;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acute renal failure, post liver transplant