N-acetylcysteine in Liver Transplantation

• Status: Completed
• Trial end date: 2008-01-01
• Target enrollment: 0
• Participant gender: All

Summary

N-acetylcysteine (NAC) is used to treat Tylenol toxicity. NAC is a rich source of the sulfhydryl group (SH) which is important for replenishing the body's glutathione stores. Glutathione acts as a free radical scavenger, to decrease the damage that would be caused by those toxic radicals. Patients who undergo orthotopic liver transplantation (OLT) have a high incidence of post-operative renal dysfunction. The most common etiology of post-operative renal dysfunction is related to high levels of toxic free radicals. Free radicals may contribute to primary liver graft failure or delayed liver graft function.

Specific Aims & Objectives:

The primary objective of this study is to evaluate the efficacy of NAC in improving liver graft performance and lowering the incidence of post-operative renal dysfunction. The secondary objectives are to investigate the effect of NAC on endogenous glutathione body stores and its effect on FK506 induced toxicity.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ibtesam Hilmi; University of Pittsburgh
• Treatments: Acetylcysteine; Cystatins; N-monoacetylcystine

Criteria

Inclusion Criteria:

• Male or female patients age of 18 years

• Patients undergoing cadaveric liver transplant for the first time

• Patients with normal serum creatinine < 1- 1.2 mg/dl or creatinine clearance 97-140 ml/min and patients with mild renal dysfunction with serum creatinine of (2-2.5 mg/dl) or creatinine clearance 85-125 ml/min

• All patients will sign informed consent

Exclusion Criteria:

• Allergy to NAC

• Patients with history of asthma

• Patient with fulminate hepatic failure

• Re-do OLT

• Simultaneous other organ transplant (i.e., pancreas, heart, and small bowel)

• Pre-existing renal failure requiring hemodialysis or continuous hemofiltration and patient refusal to participate in the study.

• Although, it is extremely uncommon for a patient with hepatic failure to become pregnant due to the pathological effect of hepatic failure on the reproductive system, the policy of Liver Transplantation Service at UPMC is to advise young female not to become pregnant while waiting for OLT. In addition the majority of the patients on the liver transplant waiting list at this institution are above 50 years of age. However, when a female patient of child-bearing potential is called in for OLT and there is a suspicion that she might be pregnant, a blood pregnancy test will be performed as a part of the standard of care for these patients.