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TaurineTaurine/LDLTNCT04047043

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

An observational study of Taurine, run by Ain Shams University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Taurine
What is being tested?
serum taurine
How many people
60 participants
Where
1 siteEgypt
Study dates
1 Aug 2019to 30 May 2020
How long will I take part?
30 Days
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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).

Who may be able to join

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

Who cannot join

  • 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.
Show all 9Show fewer
  • Donor body mass index > 28 kg/m².
  • Donor with abnormal biliary anatomy.
  • Donor with steatosis > 10%.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Hanaa El Gendy

    Cairo, Ain Shams University Specialized Hospital

Other trials in Egypt

About this study

Official title: Evaluation of Serum Taurine as a Prognostic Marker for Graft Function in Adult Egyptian Patients Undergoing Living Donor Liver Transplant : A Prospective Study

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

Read the detailed description
  • All selected adult patients undergoing LDLT will be admitted to the ICU post LDLT
  • Preoperative assessment and preparation will be done according to the standard protocol of the hospital. After full clinical examinations using MELD score corrected for serum sodium level ), imaging techniques (Abdominal U.S; abdominal triphasic CAT Scan, liver biopsy, CT volumetry, upper and lower GIT endoscopy, CT chest, bone scan in HCC patients, renal scan in patients with urinary creatinine clearance < 60 ml/min), pulmonary function test, carotid duplex and dobutamine ECHO will be done for all recipients .
  • Serum level of AST, ALT, bilirubin, albumin, ALP, GGT, prothrombin, INR, partial thrombin time, factor V, fasting blood glucose, CBC, CRP, Procalcitonin, urea, creatinine, urinary creatinine clearance, serum electrolytes, urine and stool analysis will be done for all patients.
  • Analysis of serum levels of specific liver tumor markers including AFP, beside taurine as a possible new marker will be done for all patients .
  • HCV and HBV will be detected for all patients by PCR technique.
  • CMV IgM , EBV IgM ,HSV IgM will be done for all patients.
  • After 12 hours fasting, 10 ml of venous blood will be collected, in plain tube and allowed to clot for 1/2 an hour. Then, it will be centrifuged at 3,000 rpm for 10 min. The serum will be separated and stored at -20 Cº to avoid loss of biological activity until the batch analysis for serum taurine which will be measured four times for the recipient ( preoperative before induction of anesthesia , 7, 14 days and 30 days post transplant ) by high performance liquid chromatography (HPLC) .

Recipient patients will be divided into 3 groups according to preoperative serum taurine .

  • Group 1 ( > 30 μmol/L) (20 cases)
  • Group 2 (30-20 μmol/L) (20 cases)
  • Group 3 (< 20 μmol/L ) (20 cases)

Intraoperatively, both standard anesthetic and piggyback techniques for hepatic transplantation will be performed by the same anesthesia and surgical team who will be blinded to study medication. Intraoperative blood loss, graft weight, graft weight to recipient weight ratio (GWRWR), blood products transfused, and intraoperative adverse events will be recorded. At the end of surgery, patients will be transferred to the ICU and will be monitored and receive the standard protocol for postoperative management after liver transplantation .

All patients will be assessed for primary graft function (PGF) on a daily basis during the first week post-transplant. Primary graft dysfunction includes one or more of the following variables: (1) bilirubin ≥10 mg/dL on postoperative day 7; (2) INR ≥1.6 on postoperative day 7; and (3) ALT or AST >2000 IU/L within 7 postoperative days.

The primary outcome include correlation between serum taurine levels ( μmol/L) of recipients and graft function which will be detected by liver profile. Secondary outcomes include 30 days mortality (days), the duration of ICU and hospital stays (days) and any recorded post operative complications.

Conditions
Taurine
Being tested
serum taurine
Keywords
Taurine/graft function/LDLT

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • serum taurineDiagnostic test

    blood sample for serum taurine level

Study groups in NCT04047043
Study groupRoleWhat they receive
Taurine > 30 μmol/Lserum taurine level
Receives: Diagnostic Test: serum taurine
Taurine 30-20 μmol/Lserum taurine level
Receives: Diagnostic Test: serum taurine
Taurine < 20 μmol/Lserum taurine level
Receives: Diagnostic Test: serum taurine

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 7 months

Secondary outcomes (1)
  1. Seventh day syndrome, 30 days mortality (days), the duration of ICU and hospital stays (days).

    Taurine level will be correlated with these parameters

    Measured: 7 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Aug 2019
  2. Study start1 Aug 2019
  3. Primary completion30 May 2020
  4. Study completion30 May 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
60 participants (actual)
Target duration
30 Days
IDs, dates and publications
ClinicalTrials.gov ID
NCT04047043
Sponsor's protocol ID
IRB 0006379
Acronym
Taurine/LDLT
Status last verified
Aug 2020
First submitted
31 Jul 2019
Last updated
24 Aug 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Taurine, run by Ain Shams University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Taurine level in micro mol/L (time frame: 7 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2020.

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