N-acetylcysteine in Liver Transplantation

NCT00736541 | Completed DMC

• 1 other identifier: N-acetylcysteine in OLT
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

End Stage Liver Failure

Keywords

ARF; OLT; NAC; I/R injury

Outcome Measures

Primary Outcomes (1)

• improve patient and graft outcome. reduce the incidence of postoperative renal dysfunction

  one year

Study Arms (1)

2

EXPERIMENTAL

Drug: N-acetylcysteine

Interventions

N-acetylcysteine DRUG

The patients in the NAC group will receive a loading dose of 140 mg/kg IV of NAC over one hour at the start of the surgery. Thereafter, NAC will be repeated every 4 hours at a dose of 70 mg/kg IV, for a total of 13 doses

Also known as: NAC, GSH, cystatin-c, beta-trace

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ibtesam Hilmi: lead

Study Sites (1)

Unversity of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Interventions

Acetylcysteine; Glutathione; Cystatin C; prostaglandin R2 D-isomerase

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Oligopeptides; Peptides; Cystatins; Proteins

Study Officials

• Ibtesam A Hilmi, MB CHB, FRCA

  University of Pittsburgh Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 14, 2008
• First Posted: August 18, 2008
• Study Start: July 1, 2004
• Primary Completion: April 1, 2007
• Study Completion: January 1, 2008
• Last Updated: April 28, 2023

Record last verified: 2023-04

Locations

US (1)