Evaluation of Serum Taurine as a Prognostic Marker for Graft Function in Adult Egyptian Patients Undergoing Living Donor Liver Transplant

NCT04047043 | Completed DMC

• 1 other identifier: IRB 0006379
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Although the hepatoprotective properties of taurine are well established, however the correlation of the perioperative serum level of this amino acid in the recipients of living donor liver transplantation ( LDLT ) and graft function has not been investigated so far. In the present study, we proposed to examine the serum taurine as a prognostic marker for graft function in adult Egyptian patients undergoing LDLT

Conditions

Taurine

Keywords

Taurine/graft function/LDLT

Outcome Measures

Primary Outcomes (1)

• Taurine level in micro mol/L

  Taurine level preoperative, 7th,14 th and 30 days post liver transplantation will be assesd and correlated with graft function

  7 months

Secondary Outcomes (1)

• Seventh day syndrome, 30 days mortality (days), the duration of ICU and hospital stays (days).

  7 months

Study Arms (3)

Taurine > 30 μmol/L

serum taurine level

Diagnostic Test: serum taurine

Taurine 30-20 μmol/L

serum taurine level

Diagnostic Test: serum taurine

Taurine < 20 μmol/L

serum taurine level

Diagnostic Test: serum taurine

Interventions

serum taurine DIAGNOSTIC_TEST

blood sample for serum taurine level

Taurine 30-20 μmol/L; Taurine < 20 μmol/L; Taurine > 30 μmol/L

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

After reviewing of literature, no previous similar research was done before to study the effect of recipient serum taurine on graft survival after living donor liver transplant). So considering an exploratory study, the study will include 20 cases with taurine \>30 μmol/L, 20 cases with taurine 20-30 μmol/L and 20 cases with taurine \<20 μmol/L (60 total).

You may qualify if:

• Recipient age ≥18 years.
• Donor age between 18 and 45 years
• ABO group compatibility with the recipient
• Normal psychological workup.

You may not qualify if:

• Recipients patients with pre-existing renal failure requiring hemodialysis or continuous hemofiltration, glomerular filtration rate ≤ 30 ml /min by renal scan, ..
• Re-transplant
• HA1C \> 7%
• Pregnancy.
• Donors with fatty liver.
• Estimated remnant liver volume for donor is \< 30% of total liver volume.
• Donor body mass index \> 28 kg/m².
• Donor with abnormal biliary anatomy.
• Donor with steatosis \> 10%.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Hanaa El Gendy

Cairo, Ain Shams University Specialized Hospital, Egypt

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 31, 2019
• First Posted: August 6, 2019
• Study Start: August 1, 2019
• Primary Completion: May 30, 2020
• Study Completion: May 30, 2020
• Last Updated: August 24, 2020

Record last verified: 2020-08

Locations

EG (1)