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Acute Renal Failure Post Liver Transplantation

Primary Purpose

Acute Renal Failure

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
N-acetylcysteine
Placebo
Sponsored by
Baylor Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Renal Failure focused on measuring acute renal failure, post liver transplant

Eligibility Criteria

18 Years - 71 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • First liver transplant
  • Normal renal function before transplantation [serum creatinine ≤ 1.5 mg / dl]
  • No requirements for dialysis before transplantation
  • Age greater than 18 years

Exclusion Criteria:

  • Re-transplant
  • 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

Sites / Locations

  • Annette C. and Harold C. Simmons Tranplant Institute at Baylor Medical Center Dallas

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

600 mg N-acetylcysteine or placebo IV

600 mg N-acetylcysteine or placebo NG

N-acetylcysteine or placebo q 12 hour

Arm Description

600 mg N-acetylcysteine or placebo IV perfused over 15 minutes during the transplant procedure, prior to reperfusion,

600 mg NAC or placebo administered via NG tube starting at 12 hrs + 30 min post O.R. infusion,

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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
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

Full Information

First Posted
November 16, 2012
Last Updated
February 20, 2020
Sponsor
Baylor Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01907061
Brief Title
Acute Renal Failure Post Liver Transplantation
Official Title
Acute Renal Failure Post Liver Transplantation: The Role of Cytokines and Oxidative Stress
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Baylor Research Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
Detailed Description
To determine levels of pro-inflammatory cytokines and oxidative stress markers in liver transplant patients during post-transplant period To correlate changes in pro-inflammatory cytokines and markers of oxidative stress to acute renal failure and acute rejection 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Renal Failure
Keywords
acute renal failure, post liver transplant

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
600 mg N-acetylcysteine or placebo IV
Arm Type
Active Comparator
Arm Description
600 mg N-acetylcysteine or placebo IV perfused over 15 minutes during the transplant procedure, prior to reperfusion,
Arm Title
600 mg N-acetylcysteine or placebo NG
Arm Type
Active Comparator
Arm Description
600 mg NAC or placebo administered via NG tube starting at 12 hrs + 30 min post O.R. infusion,
Arm Title
N-acetylcysteine or placebo q 12 hour
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
N-acetylcysteine
Other Intervention Name(s)
NAC
Intervention Description
drug will be administered via IV,NG
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo in place of NAC
Intervention Description
placebo or NAC will be given
Primary Outcome Measure Information:
Title
To determine levels of pro-inflammatory cytokines and oxidative stress markers in liver transplant patients during post-transplant period
Description
Cytokines in patients receiving N-acetylcysteine versus those receiving placebo during liver transplantation will be compared.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
To correlate changes in pro-inflammatory cytokines and markers of oxidative stress to acute renal failure and acute rejection
Description
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
Time Frame
6 months
Title
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
Description
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
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
71 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: First liver transplant Normal renal function before transplantation [serum creatinine ≤ 1.5 mg / dl] No requirements for dialysis before transplantation Age greater than 18 years Exclusion Criteria: Re-transplant 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yousri M. Barri, MD
Organizational Affiliation
Baylor Health Care System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Annette C. and Harold C. Simmons Tranplant Institute at Baylor Medical Center Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Acute Renal Failure Post Liver Transplantation

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