Acute Renal Failure Post Liver Transplantation

Acute Renal Failure Clinical Trial

Official title:

Acute Renal Failure Post Liver Transplantation: The Role of Cytokines and Oxidative Stress

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01907061
• Other study ID #: 007-157
• Status: Completed
• Phase: N/A
• Start date: July 2007
• Est. completion date: July 2014

Study information

• Verified date: February 2020
• Source: Baylor Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

1. To determine levels of pro-inflammatory cytokines and oxidative stress markers in liver transplant patients during post-transplant period

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 71 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Acute Renal Failure
• Renal Insufficiency

Intervention

Drug:
• N-acetylcysteine
drug will be administered via IV,NG
• Placebo
placebo or NAC will be given

Locations

Country	Name	City	State
United States	Annette C. and Harold C. Simmons Tranplant Institute at Baylor Medical Center Dallas	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Baylor Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	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	6 months