Effect of N_Acetylcysteine on Liver Functions in Donors in Living Liver Transplantation

Liver Transplant; Complications Clinical Trial

Official title:

Effect of N_Acetylcysteine on Liver Functions in Donors in Living Donor Liver Transplantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03634566
• Other study ID #: R 10/2018
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: April 1, 2018
• Est. completion date: April 1, 2019

Study information

• Verified date: October 2019
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 1, 2019
• Est. primary completion date: February 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• ASA I or II donors

• healthy adult

Exclusion Criteria:

• kidney, liver disease

• any contraindications for organ donation

Related Conditions & MeSH terms

• Liver Transplant; Complications

Intervention

Drug:
• N-Acetylecysteine
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
Ringer acetate continuous infusion at the same rate for 2 days.

Locations

Country	Name	City	State
Egypt	Faculty of medicine	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum lactate		24 hours postoperative