Status:
COMPLETED
N-acetylcysteine in Liver Transplantation
Lead Sponsor:
Ibtesam Hilmi
Conditions:
End Stage Liver Failure
Eligibility:
All Genders
18+ years
Phase:
NA
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 fre...
Detailed Description
This is a randomized, double-blind placebo-controlled study that investigates the use of NAC during and after OLT. A total of 100 patients will be recruited. Fifty will receive a placebo (normal salin...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00736541
Start Date
July 1 2004
End Date
January 1 2008
Last Update
April 28 2023
Active Locations (1)
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1
Unversity of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213