Acute Renal Failure Post Liver Transplantation

Baylor Scott and White Health (BSWH)

Status: Completed

Conditions: Acute Renal Failure

Treatments: Drug: Placebo; Drug: N-acetylcysteine

Study type: Interventional

Funder types: Other

Identifiers

NCT01907061

007-157

Details and patient eligibility

About

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

Full 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

Enrollment: 30 patients

Sex: All

Ages: 18 to 71 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

600 mg N-acetylcysteine or placebo IV

Active Comparator group

Description:

600 mg N-acetylcysteine or placebo IV perfused over 15 minutes during the transplant procedure, prior to reperfusion,

Treatment:

Drug: Placebo

Drug: N-acetylcysteine

600 mg N-acetylcysteine or placebo NG

Active Comparator group

Description:

600 mg NAC or placebo administered via NG tube starting at 12 hrs + 30 min post O.R. infusion,

Treatment:

Drug: Placebo

Drug: N-acetylcysteine

N-acetylcysteine or placebo q 12 hour

Active Comparator group

Description:

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.

Treatment:

Drug: Placebo

Drug: N-acetylcysteine