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Acute Renal Failure Post Liver Transplantation

Baylor Scott and White Health (BSWH) logo

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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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