- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03634566
Effect of N_Acetylcysteine on Liver Functions in Donors in Living Liver Transplantation
January 30, 2020 updated by: Mona Ammar, Ain Shams University
Effect of N_Acetylcysteine on Liver Functions in Donors in Living Donor Liver Transplantation
our practice for the past 10 years we have noticed a transitional impairment of liver function (elevated liver enzymes, total and direct bilirubin, and elevated serum lactate levels) following donors' liver resection.
Several drugs have been investigation on liver regeneration , proven benefit of N-Acetylcysteine (NAC) on rats with steatohpatitis
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Cairo, Egypt
- Faculty of Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- ASA I or II donors
- healthy adult
Exclusion Criteria:
- kidney, liver disease
- any contraindications for organ donation
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: NAC group
Group NC received NAC 150 mg/kg diluted in 100 ml glucose 5 % over 40 minutes followed by NAC 12.5 mg/kg in 500 ml glucose 5% over 4 hours, followed by NAC 6.25 mg/kg for 2 postoperative days
|
N-Acetylecysteine 150 mg/kg diluted in 100 ml glucose 5 % over 40 minutes followed by NAC 12.5 mg/kg in 500 ml glucose 5% over 4 hours, followed by NAC 6.25 mg/kg for 2 postoperative days
|
Placebo Comparator: Control group
Group C (Control group) will receive ringer acetate continuous infusion at same rate for 2 days.
|
Ringer acetate continuous infusion at the same rate for 2 days.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Serum lactate
Time Frame: 24 hours postoperative
|
24 hours postoperative
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2018
Primary Completion (Actual)
February 1, 2019
Study Completion (Actual)
April 1, 2019
Study Registration Dates
First Submitted
August 13, 2018
First Submitted That Met QC Criteria
August 15, 2018
First Posted (Actual)
August 16, 2018
Study Record Updates
Last Update Posted (Actual)
February 5, 2020
Last Update Submitted That Met QC Criteria
January 30, 2020
Last Verified
October 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- R 10/2018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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