Liver Transplant; ComplicationsNCT06123260
Renal Outcomes Among Post Liver Transplantation Patients
An observational study of Liver Transplant; Complications and Renal Complication of Procedure, run by Assiut University.
Trial summary
To evaluate Renal outcomes among patients, post liver transplantation at Assiut university. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Liver Transplant; Complications, Renal Complication of Procedure
- What is being tested?
- renal function tests
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2023to 1 Jan 2025
- How long will I take part?
- 3 Years
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: retrospective cohort study will be done to patients post liver transplantation at El Raghy university hospital
Who may be able to join
- Data of all Patients underwent liver transplants with their reports available at El Raghy university hospital
Who cannot join
- Inadequate data
- Patients on dialysis more than 8 weeks pre liver transplant.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Short Term Renal Outcomes Among Post Liver Transplantation Patients at Assiut University
To evaluate Renal outcomes among patients, post liver transplantation at Assiut university.
Read the detailed description
It is estimated that 1 in 4 liver transplantation (LT) recipients has an estimated glomerular filtration rate (eGFR) of <60mL/minute/1.73 m2 at the time of LT Renal dysfunction, both before or after LT, is an important comorbidity associated with an increased risk of death, morbidity, and cost. Serum creatinine, a major component of the Model for End-Stage Liver Disease (MELD) score, has driven the increased incidence of renal dysfunction among patients undergoing LT End-stage liver disease (ESLD) is commonly complicated by kidney dysfunction, which in turn leads to a worse prognosis. The kidney dysfunction can be functional or structural, ranging from prerenal azotemia and hepatorenal syndrome causing acute kidney injury to immunoglobulin A (IgA) nephropathy (IgAN) and membranoproliferative glomerulonephritis causing chronic kidney disease Each condition carries a different presentation, treatment, prognosis, and risk of recurrence. Therefore, when ESLD patients undergo evaluation for liver transplant, it is critical to assess their kidney function and understand the cause of any underlying kidney dysfunction LT recipients will continue to worsen due to calcineurin inhibitor toxicity and lack of recovery from hepatorenal syndrome (HRS), necessitating renal replacement therapy Patients who are not expected to recover their kidney function after liver transplant usually benefit from combined liver and kidney transplant (CLKT). Others may need modified immunosuppressive regimens that minimize or avoid use of calcineurin inhibitors to preserve the remaining kidney function.
For assessment of kidney function, Equations that estimate GFR are most commonly used in daily practice. They have the advantage of being inexpensive and results are immediately available. Their disadvantage is that they rely on endogenous biomarkers, which are confounded by non-GFR determinants such as age, sex, muscle mass, drugs, certain chronic conditions, diet and presumably many more Creatinine, the most commonly used biomarker, depends heavily on muscle mass. Pre and intraoperative factors and postoperative complications were evaluated for their impact on development of AKI The preoperative factors MELD, SCr, Bilirubin and INR were highly associated with an increased risk for developing AKI requiring RRT for the post OLT complications, length of ICU stay was associated with the development of AKI Patients with a longer ventilation time and a higher amount of RPC transfusion were more likely to have AKI requiring RRT, whereas these parameters were not associated with milder forms of AKI.
- Being tested
- renal function tests
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
renal function testsDiagnostic test
BUN, eGFR , CBC , Electrolytes , Liver function tests
What is being measured
The primary outcome is the main question the study is designed to answer.
calculation the incidence of AKI in Liver transplantation patients
Determination of the most common risk factor for AKI in liver transplantation patients.
Measured: Baseline
Secondary outcomes (1)
mortality rate
patient survival in post LT AKI group.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2023
- Study start1 Dec 2023 (estimated)
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Liver Transplant; ComplicationsStudies of the same condition, open and under way.
- More trials run by Assiut 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
- 50 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ebram Magdy Eskander Nashed, Assiut University
- Investigators
- Bahaa Osman Taha, Master, Study director, Bahaa_osman99@aun.edu.eg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06123260
- Sponsor's protocol ID
- renal outcomes post OLT
- Status last verified
- Nov 2023
- First submitted
- 2 Nov 2023
- Last updated
- 8 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Feffer SE, Parray HR, Westring DW. Seizure after infusion of aminocaproic acid. JAMA. 1978 Nov 24;240(22):2468. No abstract available.
PubMed 101682Rautela GS, Snee RD, Miller WK. Response-surface co-optimization of reaction conditions in clinical chemical methods. Clin Chem. 1979 Nov;25(11):1954-64.
PubMed 498506Ramakrishnan R, Mittal S, Ambatkar S, Kader MA. Retinal nerve fibre layer thickness measurements in normal Indian population by optical coherence tomography. Indian J Ophthalmol. 2006 Mar;54(1):11-5. doi: 10.4103/0301-4738.21608.
PubMed 16531664Braun OH, Kreipe U. [Rare forms of chronic osteomyelitis in children (author's transl)]. Klin Padiatr. 1979 Sep;191(5):511-21. German.
PubMed 574584Pannuti F. Surgical adjuvant hormone therapy in breast cancer. Arch Geschwulstforsch. 1978;48(7):680-2. No abstract available.
PubMed 736749Pozenel H. [The influence of mexiletin on ventricular arrhythmias during ergometric exercise (author's transl)]. Wien Klin Wochenschr. 1977 Dec 9;89(23):783-8. German.
PubMed 595602Blom E. A decapitated sperm defect in two sterile Hereford bulls. Nord Vet Med. 1977 Mar;29(3):119-23.
PubMed 870880
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Term Renal Outcomes Among Post Liver Transplantation Patients at Assiut University
- ClinicalTrials.gov ID
- NCT06123260
- Acronym / sponsor ID
- renal outcomes post OLT
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 8 Nov 2023 (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.
To evaluate Renal outcomes among patients, post liver transplantation at Assiut university.
Detailed description
It is estimated that 1 in 4 liver transplantation (LT) recipients has an estimated glomerular filtration rate (eGFR) of <60mL/minute/1.73 m2 at the time of LT Renal dysfunction, both before or after LT, is an important comorbidity associated with an increased risk of death, morbidity, and cost. Serum creatinine, a major component of the Model for End-Stage Liver Disease (MELD) score, has driven the increased incidence of renal dysfunction among patients undergoing LT End-stage liver disease (ESLD) is commonly complicated by kidney dysfunction, which in turn leads to a worse prognosis. The kidney dysfunction can be functional or structural, ranging from prerenal azotemia and hepatorenal syndrome causing acute kidney injury to immunoglobulin A (IgA) nephropathy (IgAN) and membranoproliferative glomerulonephritis causing chronic kidney disease Each condition carries a different presentation, treatment, prognosis, and risk of recurrence. Therefore, when ESLD patients undergo evaluation for liver transplant, it is critical to assess their kidney function and understand the cause of any underlying kidney dysfunction LT recipients will continue to worsen due to calcineurin inhibitor toxicity and lack of recovery from hepatorenal syndrome (HRS), necessitating renal replacement therapy Patients who are not expected to recover their kidney function after liver transplant usually benefit from combined liver and kidney transplant (CLKT). Others may need modified immunosuppressive regimens that minimize or avoid use of calcineurin inhibitors to preserve the remaining kidney function.
For assessment of kidney function, Equations that estimate GFR are most commonly used in daily practice. They have the advantage of being inexpensive and results are immediately available. Their disadvantage is that they rely on endogenous biomarkers, which are confounded by non-GFR determinants such as age, sex, muscle mass, drugs, certain chronic conditions, diet and presumably many more Creatinine, the most commonly used biomarker, depends heavily on muscle mass. Pre and intraoperative factors and postoperative complications were evaluated for their impact on development of AKI The preoperative factors MELD, SCr, Bilirubin and INR were highly associated with an increased risk for developing AKI requiring RRT for the post OLT complications, length of ICU stay was associated with the development of AKI Patients with a longer ventilation time and a higher amount of RPC transfusion were more likely to have AKI requiring RRT, whereas these parameters were not associated with milder forms of AKI.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- retrospective cohort study will be done to patients post liver transplantation at El Raghy university hospital
Key inclusion criteria (1 listed)
- Data of all Patients underwent liver transplants with their reports available at El Raghy university hospital
Key exclusion criteria (2 listed)
- Inadequate data
- Patients on dialysis more than 8 weeks pre liver transplant.
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 |
|---|---|---|
| renal function testsBUN, eGFR , CBC , Electrolytes , Liver function tests | Diagnostic test | – |
Primary outcome
calculation the incidence of AKI in Liver transplantation patients
Time frame: Baseline
Determination of the most common risk factor for AKI in liver transplantation patients.
1 secondary outcome
mortality rate
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2023.
- Background: PubMed 101682Feffer SE, Parray HR, Westring DW. Seizure after infusion of aminocaproic acid. JAMA. 1978 Nov 24;240(22):2468. No abstract available.
- Background: PubMed 498506Rautela GS, Snee RD, Miller WK. Response-surface co-optimization of reaction conditions in clinical chemical methods. Clin Chem. 1979 Nov;25(11):1954-64.
- Background: PubMed 16531664Ramakrishnan R, Mittal S, Ambatkar S, Kader MA. Retinal nerve fibre layer thickness measurements in normal Indian population by optical coherence tomography. Indian J Ophthalmol. 2006 Mar;54(1):11-5. doi: 10.4103/0301-4738.21608.
- Background: PubMed 574584Braun OH, Kreipe U. [Rare forms of chronic osteomyelitis in children (author's transl)]. Klin Padiatr. 1979 Sep;191(5):511-21. German.
- Background: PubMed 736749Pannuti F. Surgical adjuvant hormone therapy in breast cancer. Arch Geschwulstforsch. 1978;48(7):680-2. No abstract available.
- Background: PubMed 595602Pozenel H. [The influence of mexiletin on ventricular arrhythmias during ergometric exercise (author's transl)]. Wien Klin Wochenschr. 1977 Dec 9;89(23):783-8. German.
- Background: PubMed 870880Blom E. A decapitated sperm defect in two sterile Hereford bulls. Nord Vet Med. 1977 Mar;29(3):119-23.
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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.
Bahaa Osman Taha, Master study director
Bahaa_osman99@aun.edu.eg
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Transplant; Complications and Renal Complication of Procedure, run by Assiut University.
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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 8 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ebram Magdy Eskander, M.B.B.Ch (01116094001, ebrammagdy93@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
calculation the incidence of AKI in Liver transplantation patients (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06123260, which also lists 7 linked publications.
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 8 Nov 2023.