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

NCT ID: NCT03634566

Last Updated: 2020-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-01

Study Completion Date

2019-04-01

Brief Summary

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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

Detailed Description

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Conditions

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Liver Transplant; Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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

Group Type ACTIVE_COMPARATOR

N-Acetylecysteine

Intervention Type DRUG

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

Control group

Group C (Control group) will receive ringer acetate continuous infusion at same rate for 2 days.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Ringer acetate continuous infusion at the same rate for 2 days.

Interventions

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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

Intervention Type DRUG

Placebo

Ringer acetate continuous infusion at the same rate for 2 days.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* ASA I or II donors
* healthy adult

Exclusion Criteria

* kidney, liver disease
* any contraindications for organ donation
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Mona Ammar

Lecturer of anesthesia,intensive care and pain management

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of medicine

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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R 10/2018

Identifier Type: -

Identifier Source: org_study_id

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