Acute Renal Failure Post Liver Transplantation
- Conditions
- Acute Renal Failure
- Interventions
- Drug: Placebo
- Registration Number
- NCT01907061
- Lead Sponsor
- Baylor Research Institute
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 600 mg N-acetylcysteine or placebo NG Placebo 600 mg NAC or placebo administered via NG tube starting at 12 hrs + 30 min post O.R. infusion, 600 mg N-acetylcysteine or placebo IV N-acetylcysteine 600 mg N-acetylcysteine or placebo IV perfused over 15 minutes during the transplant procedure, prior to reperfusion, 600 mg N-acetylcysteine or placebo IV Placebo 600 mg N-acetylcysteine or placebo IV perfused over 15 minutes during the transplant procedure, prior to reperfusion, N-acetylcysteine or placebo q 12 hour N-acetylcysteine 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. N-acetylcysteine or placebo q 12 hour Placebo 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. 600 mg N-acetylcysteine or placebo NG N-acetylcysteine 600 mg NAC or placebo administered via NG tube starting at 12 hrs + 30 min post O.R. infusion,
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
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
Trial Locations
- Locations (1)
Annette C. and Harold C. Simmons Tranplant Institute at Baylor Medical Center Dallas
🇺🇸Dallas, Texas, United States