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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 600 mg N-acetylcysteine or placebo IV | Active Comparator | 600 mg N-acetylcysteine or placebo IV perfused over 15 minutes during the transplant procedure, prior to reperfusion, |
|
| 600 mg N-acetylcysteine or placebo NG | Active Comparator | 600 mg NAC or placebo administered via NG tube starting at 12 hrs + 30 min post O.R. infusion, |
|
| N-acetylcysteine or placebo q 12 hour | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| N-acetylcysteine | Drug | drug will be administered via IV,NG |
|
| Measure | Description | Time Frame |
|---|---|---|
| To determine levels of pro-inflammatory cytokines and oxidative stress markers in liver transplant patients during post-transplant period | Cytokines in patients receiving N-acetylcysteine versus those receiving placebo during liver transplantation will be compared. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| To correlate changes in pro-inflammatory cytokines and markers of oxidative stress to acute renal failure and acute rejection | F2-isoprostanes levels in the two groups will be compared to evaluate the role in acute renal failure and acute rejection in patients recieving a liver transplant | 6 months |
| iTo determine the impact of using N-acetylcysteine on cytokines and markers of oxidative stress and the incidence of acute renal failure post liver transplantation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yousri M. Barri, MD | Baylor Health Care System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Annette C. and Harold C. Simmons Tranplant Institute at Baylor Medical Center Dallas | Dallas | Texas | 75246 | United States |
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| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D000111 | Acetylcysteine |
| ID | Term |
|---|---|
| D003545 | Cysteine |
| D000603 | Amino Acids, Sulfur |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| Placebo | Drug | placebo or NAC will be given |
|
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N-acetylcysteine or placebo will be given to patients recieving a liver tranplant cytokines and oxidative stress markers will be compared between the two groups to determine if N-acetylcysteine will impact acute renal failure post liver transplantation |
| 6 months |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D000596 |
| Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |