Acute Renal Failure
Conditions
Keywords
acute renal failure, post liver transplant
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
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
Interventions
DRUGN-acetylcysteine
drug will be administered via IV,NG
DRUGPlacebo
placebo or NAC will be given
Sponsors
Baylor Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 71 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Countries
United States
Outcome results
None listed