Effect of Ramadan Fasting on Muslim Recipients After Living Donor Liver Transplantation

NCT03592524 | Completed DMC

• 1 other identifier: Ramadan fasting and liver
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

The study aimed to assess the possibility of Ramadan fasting and to start protocol of adapting immunosupression regiment and scheduled follow up for patients wishing to fast after liver transplantation (LT).

Conditions

Liver Transplantation

Outcome Measures

Primary Outcomes (3)

• Effect of fasting on Allograft function among recipients post liver transplantation

  Comparison between pre and post fasting state as regards allograft lfunctions , reflected by measuring AST, ALT(liver enzymes) , serum bilirubin , serum albumin +\\\_ liver biopsy if rejection is suspected

  1 month

• Effect of fasting Ramadan on renal functions among recipients post liver transplantation

  Comparison between fasting and post fasting renal functions ( serum creatinine, Blood urea nitrogen ,serum sodium and potassium

  1 month

• Effect of Ramadan fasting on immunosuppressant trough level in liver transplantation recipients

  Comparison between fasting and post fasting immunosuppressant drugs trough levels

  1 month

Secondary Outcomes (2)

• Effect of Ramadan fasting on blood pressure Among hypertensive recipients on antihypertensive drugs

  1 month

• Effect of fasting Ramadan on blood sugar control among diabetics recipients

  1 month

Interventions

Fasting Ramadan BEHAVIORAL

Muslims recipients refrain from eating and drinking anything from dawn until sunset(14-15 hours)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients underwent Living donor liver transplantation

You may qualify if:

• Recipients completed their first year after LDLT
• Normal liver and renal functions at least in the last 3 months before fasting
• No reported rejection episodes in the last 6 months before the study
• Recipients wishing to fast Ramadan
• Informed consent about the study

You may not qualify if:

• First year of LDLT
• Recipients transplanted for Budd Chiari syndrome
• Recipients with vascular stents (hepatic artery , portal vein or hepatic vein stents) requiring long life anticoagulation
• Creatinine clearance \<60 ml/min or serum creatinine \>1.5 mg/dl at time of initial enrolment in the study.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Iman Montasser

Cairo, 11566, Egypt

Location

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor of tropical medicine , Ain Shams university

Study Record Dates

• First Submitted: June 22, 2018
• First Posted: July 19, 2018
• Study Start: May 17, 2018
• Primary Completion: June 14, 2018
• Study Completion: June 21, 2018
• Last Updated: July 19, 2018

Record last verified: 2018-07

Locations

EG (1)