NCT01907061

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
5.4 years until next milestone

First Submitted

Initial submission to the registry

November 16, 2012

Completed
8 months until next milestone

First Posted

Study publicly available on registry

July 24, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

February 21, 2020

Status Verified

February 1, 2020

Enrollment Period

7 years

First QC Date

November 16, 2012

Last Update Submit

February 20, 2020

Conditions

Acute Renal Failure

Keywords

acute renal failurepost liver transplant

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • To correlate changes in pro-inflammatory cytokines and markers of oxidative stress to acute renal failure and acute rejection

    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

    6 months

Study Arms (3)

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,

Drug: N-acetylcysteineDrug: Placebo

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,

Drug: N-acetylcysteineDrug: Placebo

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.

Drug: N-acetylcysteineDrug: Placebo

Interventions

N-acetylcysteineDRUG

drug will be administered via IV,NG

Also known as: NAC
600 mg N-acetylcysteine or placebo IV600 mg N-acetylcysteine or placebo NGN-acetylcysteine or placebo q 12 hour
PlaceboDRUG

placebo or NAC will be given

Also known as: Placebo in place of NAC
600 mg N-acetylcysteine or placebo IV600 mg N-acetylcysteine or placebo NGN-acetylcysteine or placebo q 12 hour

Eligibility Criteria

Age18 Years - 71 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Dallas, Texas, 75246, United States

Location

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

CysteineAmino Acids, SulfurSulfur CompoundsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Yousri M. Barri, MD

    Baylor Health Care System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2012

First Posted

July 24, 2013

Study Start

July 1, 2007

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

February 21, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)