Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2007-07-31
2014-07-31
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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600 mg N-acetylcysteine or placebo IV
600 mg N-acetylcysteine or placebo IV perfused over 15 minutes during the transplant procedure, prior to reperfusion,
N-acetylcysteine
drug will be administered via IV,NG
Placebo
placebo or NAC will be given
600 mg N-acetylcysteine or placebo NG
600 mg NAC or placebo administered via NG tube starting at 12 hrs + 30 min post O.R. infusion,
N-acetylcysteine
drug will be administered via IV,NG
Placebo
placebo or NAC will be given
N-acetylcysteine or placebo q 12 hour
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.
N-acetylcysteine
drug will be administered via IV,NG
Placebo
placebo or NAC will be given
Interventions
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N-acetylcysteine
drug will be administered via IV,NG
Placebo
placebo or NAC will be given
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Normal renal function before transplantation \[serum creatinine ≤ 1.5 mg / dl\]
* No requirements for dialysis before transplantation
* Age greater than 18 years
Exclusion Criteria
* 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
18 Years
71 Years
ALL
No
Sponsors
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Baylor Research Institute
OTHER
Responsible Party
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Principal Investigators
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Yousri M. Barri, MD
Role: PRINCIPAL_INVESTIGATOR
Baylor Health Care System
Locations
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Annette C. and Harold C. Simmons Tranplant Institute at Baylor Medical Center Dallas
Dallas, Texas, United States
Countries
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Other Identifiers
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007-157
Identifier Type: -
Identifier Source: org_study_id
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