Acute Kidney InjuryNCT05666232
Renal and Cardiac Risk Factors of AKI After Liver Transplantation
An observational study of Acute Kidney Injury and Acute Renal Injury, run by Mansoura University.
Trial summary
Background: Liver transplantation (LT) is an extensive operation with various factors contributing to the development of acute kidney injury in the perioperative period. Early diagnosis of AKI can improve clinical outcomes in LT recipients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Kidney Injury, Acute Renal Injury, Liver Transplant; Complications
- What is being tested?
- renal resistive index and myocardial performance index
- How many people
- 105 participants
- Where
- No sites listed yet
- Study dates
- Jan 2023to Apr 2024
- 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 65 years
- All sexes
- Adult, Older adult
Study population: Adult patients undergoing living donor liver transplantation at gastrointestinal surgery center at Mansoura University - Mansoura, Egypt.
Who may be able to join
- patients undergoing right-lobe living-donor liver transplantation
Who cannot join
- preoperative renal impairment (GFR < 60 ml/min/1.73 m2)
- known renal artery stenosis
- patient who underwent previous nephrectomy
- ischemic heart disease (patient who takes anti-ischemic measures as prescribed by a consultant cardiologist)
- Patient with arrthymia or who develop persistent intraoperative arrythmia
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Renal Resistive Index and Myocardial Performance Index for Early Prediction of Acute Kidney Injury After Living Donor Liver Transplantation
Background: Liver transplantation (LT) is an extensive operation with various factors contributing to the development of acute kidney injury in the perioperative period. Early diagnosis of AKI can improve clinical outcomes in LT recipients. Renal resistive index is measured in renal arteries and high resistive values are associated with more adverse cardiovascular events and renal failure progression. Myocardial performance index reflects overall cardiac function rather than systolic or diastolic function alone.
Aim of the study: to investigate whether combined doppler renal resistive index and myocardial performance index could predict early postoperative acute kidney injury in living donor liver transplant recipients.
Read more
Study design: a prospective observational study that will be conducted at Liver Transplantation Unit at Mansoura University on 105 consecutive living donor liver transplant recipients.
Methods: Renal resistive index (assessed by transabdominal ultrasound) and myocardial performance index (assessed by transthoracic echocardiography) will be measured just before operation, on termination of operation and then daily in the intensive care unit for 7 days. Patients will be observed for development of acute kidney injury.
Read the detailed description
This study aims to investigate whether combined doppler renal resistive index (RRI) assessed by transabdominal sonography and myocardial performance index (MPI) assessed by transthoracic echocardiography could predict early postoperative acute kidney injury in living donor liver transplant recipients.
The primary outcome is the predictive value of renal resistive index and myocardial performance index for the onset of early post living donor liver transplant acute kidney injury.
This prospective observational study will be conducted at Liver Transplantation Unit at Mansoura University from November 2022 till fulfillment of sample size after obtaining approval from Institutional Review Board (IRB). One hundred and five consecutive LDLT recipients will participate in this study after obtaining informed consents. They will be observed for the development of early postoperative acute kidney injury.
- Being tested
- renal resistive index and myocardial performance index
- Keywords
- 2-D Echocardiography, Two-Dimensional Echocardiography, renal resistive index, myocardial performance index, diagnostie test accuracy, sensitivity and specificity
- Medical subject headings
- Acute Kidney Injury, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
renal resistive index and myocardial performance indexDiagnostic test
Also called echocardiography, ultrasonography
Transthoracic echocardiography and transabdominal ultrasonography will be performed before induction of anesthesia, after termination of operation and before transmission to ICU and then daily for the early seven postoperative days.
RRI = (peak systolic velocity - end diastolic velocity) ∕ peak systolic velocity: Then, we will obtain the mean RRI from the above three measurements.
We will consider RRI ≥0.7 as abnormal and define it as subclinical AKI.
Myocardial performance index (using tissue doppler) =
(isovolumetric contraction time + isovolumetric relaxation time) / ejection time. We will consider MPI ≥0.4 as abnormal and define it as subclinical LV dysfunction.
What is being measured
The primary outcome is the main question the study is designed to answer.
early acute kidney injury (AKI)
international Club of Ascites' revised classification of AKI in cirrhotic patients as a 0.3 mg/kg increase in serum creatinine
Measured: in the early 48 postoperative hours
Secondary outcomes (6)
stage of AKI
Stage (1): serum creatinine increase 1.5- 1.9 times base line; or serum creatinine increase more than 0.3mg/dl. Stage (2): serum creat. Increase 2-2.9 times baseline. Stage (3): serum creat. Increase 3 times baseline ; or s.creat increase to 4mg/dl; or initiation of renal replacement therapy.
Measured: in the early 48 postoperative hours
late AKI
International Club of Ascites' revised classification of AKI in cirrhotic patients as a 0.3 mg/kg increase in serum creatinine or >= 50% increase in the basal serum creatinine
Measured: within 7 days
length of ICU stay
duration of ICU stay (days) in survived patients
Measured: 3 months after transplant
length of hospital stay
duration of ICU stay (days) in survived patients
Measured: 3 months after transplant
three-month mortality
all-cause mortality
Measured: 3 months after transplantation
delayed renal function
serum creatinine
Measured: 3 months after transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2022
- Study startJan 2023 (estimated)
- Primary completionJan 2024 (estimated)
- Study completionApr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amr Yassen, MD, Study chair, Mansoura University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05666232
- Sponsor's protocol ID
- MD.22.09.699
- Status last verified
- Dec 2022
- First submitted
- 18 Dec 2022
- Last updated
- 27 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The anonymized patient data will be available on reasonable request after approval of the local IRB.
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renal Resistive Index and Myocardial Performance Index for Early Prediction of Acute Kidney Injury After Living Donor Liver Transplantation
- ClinicalTrials.gov ID
- NCT05666232
- Acronym / sponsor ID
- MD.22.09.699
- Keywords
- 2-D Echocardiography, Two-Dimensional Echocardiography, renal resistive index, myocardial performance index, diagnostie test accuracy, sensitivity and specificity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Jan 2023 (estimated)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 27 Dec 2022 (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.
Background: Liver transplantation (LT) is an extensive operation with various factors contributing to the development of acute kidney injury in the perioperative period. Early diagnosis of AKI can improve clinical outcomes in LT recipients. Renal resistive index is measured in renal arteries and high resistive values are associated with more adverse cardiovascular events and renal failure progression. Myocardial performance index reflects overall cardiac function rather than systolic or diastolic function alone.
Aim of the study: to investigate whether combined doppler renal resistive index and myocardial performance index could predict early postoperative acute kidney injury in living donor liver transplant recipients.
Study design: a prospective observational study that will be conducted at Liver Transplantation Unit at Mansoura University on 105 consecutive living donor liver transplant recipients.
Methods: Renal resistive index (assessed by transabdominal ultrasound) and myocardial performance index (assessed by transthoracic echocardiography) will be measured just before operation, on termination of operation and then daily in the intensive care unit for 7 days. Patients will be observed for development of acute kidney injury.
Detailed description
This study aims to investigate whether combined doppler renal resistive index (RRI) assessed by transabdominal sonography and myocardial performance index (MPI) assessed by transthoracic echocardiography could predict early postoperative acute kidney injury in living donor liver transplant recipients.
The primary outcome is the predictive value of renal resistive index and myocardial performance index for the onset of early post living donor liver transplant acute kidney injury.
This prospective observational study will be conducted at Liver Transplantation Unit at Mansoura University from November 2022 till fulfillment of sample size after obtaining approval from Institutional Review Board (IRB). One hundred and five consecutive LDLT recipients will participate in this study after obtaining informed consents. They will be observed for the development of early postoperative acute kidney injury.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing living donor liver transplantation at gastrointestinal surgery center at Mansoura University - Mansoura, Egypt.
Key inclusion criteria (1 listed)
- patients undergoing right-lobe living-donor liver transplantation
Key exclusion criteria (5 listed)
- preoperative renal impairment (GFR < 60 ml/min/1.73 m2)
- known renal artery stenosis
- patient who underwent previous nephrectomy
- ischemic heart disease (patient who takes anti-ischemic measures as prescribed by a consultant cardiologist)
- Patient with arrthymia or who develop persistent intraoperative arrythmia
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 resistive index and myocardial performance indexAlso: echocardiography, ultrasonographyTransthoracic echocardiography and transabdominal ultrasonography will be performed before induction of anesthesia, after termination of operation and before transmission to ICU and then daily for the early seven postoperative days. RRI = (peak systolic velocity - end diastolic velocity) ∕ peak systolic velocity: Then, we will obtain the mean RRI from the above three measurements. We will consider RRI ≥0.7 as abnormal and define it as subclinical AKI. Myocardial performance index (using tissue doppler) = (isovolumetric contraction time + isovolumetric relaxation time) / ejection time. We will consider MPI ≥0.4 as abnormal and define it as subclinical LV dysfunction. | Diagnostic test | – |
Primary outcome
early acute kidney injury (AKI)
Time frame: in the early 48 postoperative hours
international Club of Ascites' revised classification of AKI in cirrhotic patients as a 0.3 mg/kg increase in serum creatinine
6 secondary outcomes
stage of AKI
Time frame: in the early 48 postoperative hours
late AKI
Time frame: within 7 days
length of ICU stay
Time frame: 3 months after transplant
length of hospital stay
Time frame: 3 months after transplant
three-month mortality
Time frame: 3 months after transplantation
delayed renal function
Time frame: 3 months after transplantation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2022.
- Individual participant dataSharing planned: Yes. The anonymized patient data will be available on reasonable request after approval of the local IRB.
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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.
Amr Yassen, MD study chair
Mansoura University Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury and Acute Renal Injury, run by Mansoura 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 5 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 27 Dec 2022. 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 Ahmed Ali El-din, MSc (1288045390 ext. +20, ahmedalieldin2000@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
early acute kidney injury (AKI) (time frame: in the early 48 postoperative hours). 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 27 Dec 2022.