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Trial record 10 of 593 for:    bilirubin AND liver function

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

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ClinicalTrials.gov Identifier: NCT03634566
Recruitment Status : Recruiting
First Posted : August 16, 2018
Last Update Posted : August 16, 2018
Sponsor:
Information provided by (Responsible Party):
Mona Ammar, Ain Shams University

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

Condition or disease Intervention/treatment Phase
Liver Transplant; Complications Drug: N-Acetylecysteine Drug: Placebo Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of N_Acetylcysteine on Liver Functions in Donors in Living Donor Liver Transplantation
Actual Study Start Date : February 8, 2017
Estimated Primary Completion Date : August 15, 2018
Estimated Study Completion Date : October 1, 2018

Resource links provided by the National Library of Medicine


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
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 Comparator: Control group
Group C (Control group) will receive ringer acetate continuous infusion at same rate for 2 days.
Drug: Placebo
Ringer acetate continuous infusion at the same rate for 2 days.




Primary Outcome Measures :
  1. Serum lactate [ Time Frame: 24 hours postoperative ]


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ASA I or II donors
  • healthy adult

Exclusion Criteria:

  • kidney, liver disease
  • any contraindications for organ donation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03634566


Locations
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Egypt
Faculty of medicine Recruiting
Cairo, Egypt
Contact: Fathy Tash, MD    01006236620    mona_3mmar@Hotmail.com   
Sponsors and Collaborators
Ain Shams University

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Responsible Party: Mona Ammar, Lecturer of anesthesia,intensive care and pain management, Ain Shams University
ClinicalTrials.gov Identifier: NCT03634566     History of Changes
Other Study ID Numbers: R 10/2018
First Posted: August 16, 2018    Key Record Dates
Last Update Posted: August 16, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Acetylcysteine
N-monoacetylcystine
Antiviral Agents
Anti-Infective Agents
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes