NCT03634566

Brief 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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Apr 2018

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

April 1, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 13, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 16, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

February 5, 2020

Status Verified

October 1, 2019

Enrollment Period

10 months

First QC Date

August 13, 2018

Last Update Submit

January 30, 2020

Conditions

Liver Transplant; Complications

Outcome Measures

Primary Outcomes (1)

  • Serum lactate

    24 hours postoperative

Study Arms (2)

NAC group

ACTIVE COMPARATOR

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

Drug: N-Acetylecysteine

Control group

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

N-AcetylecysteineDRUG

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

NAC group
PlaceboDRUG

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

Control group

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • ASA I or II donors
  • healthy adult

You may not qualify if:

  • kidney, liver disease
  • any contraindications for organ donation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of medicine

Cairo, Egypt

Location

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of anesthesia,intensive care and pain management

Study Record Dates

First Submitted

August 13, 2018

First Posted

August 16, 2018

Study Start

April 1, 2018

Primary Completion

February 1, 2019

Study Completion

April 1, 2019

Last Updated

February 5, 2020

Record last verified: 2019-10

Locations

EG(1)