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.
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.
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 group | Role | What they receive |
|---|---|---|
| Taurine > 30 μmol/L | serum taurine level Receives: Diagnostic Test: serum taurine | |
| Taurine 30-20 μmol/L | serum taurine level Receives: Diagnostic Test: serum taurine | |
| Taurine < 20 μmol/L | serum taurine level Receives: Diagnostic Test: serum taurine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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.
- First posted6 Aug 2019
- Study start1 Aug 2019
- Primary completion30 May 2020
- Study completion30 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TaurineStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hanaa Mohamed Abdallah ElGendy MD, Ain Shams University
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
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04047043
- Acronym / sponsor ID
- Taurine/LDLT / IRB 0006379
- Conditions
- Taurine
- Keywords
- Taurine/graft function/LDLT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 30 May 2020 (actual)
- Study completion
- 30 May 2020 (actual)
- First posted
- 6 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Taurine > 30 μmol/L | – | Diagnostic Test: serum taurineserum taurine level |
| Taurine 30-20 μmol/L | – | Diagnostic Test: serum taurineserum taurine level |
| Taurine < 20 μmol/L | – | Diagnostic Test: serum taurineserum taurine level |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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).
Key inclusion criteria (4 listed)
- Recipient age ≥18 years.
- Donor age between 18 and 45 years
- ABO group compatibility with the recipient
- Normal psychological workup.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| serum taurineblood sample for serum taurine level | Diagnostic test | Taurine 30-20 μmol/L, Taurine < 20 μmol/L, Taurine > 30 μmol/L |
Primary outcome
Taurine level in micro mol/L
Time frame: 7 months
Taurine level preoperative, 7th,14 th and 30 days post liver transplantation will be assesd and correlated with graft function
1 secondary outcome
Seventh day syndrome, 30 days mortality (days), the duration of ICU and hospital stays (days).
Time frame: 7 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Taurine
Not yet recruiting
Effects of Taurine Supplementation and Morning or Evening High-intensity Exercise on Circadian Clock Genes and Inflammatory Parameters in Adult Women With Obesity
Obesity (Disorder), Inflammation
RecruitingPhase 2
Taurine for the Prevention and Treatment of Radiation-induced Oral Mucositis in Patients With Nasopharyngeal Carcinoma
Oral Mucositis (Ulcerative) Due to Radiation, Nasopharyngeal Carcinoma (NPC)
Recruiting
Butyrate and Taurine for Chronic Postsurgical Pain in Adult Cardiac Surgical Patients
Pain, Acute, Pain, Chronic
Not yet recruitingPhase 1/2
Taurine Supplementation in Adolescents With Post-COVID Condition
Long COVID, Post COVID-19 Condition
RecruitingPhase 2
Taurine Effect on Glycemic, Lipidic and Inflammatory Profile in Individuals With Type 2 Diabetes
Diabetes Mellitus, Type 2
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.