Acute Kidney InjuryNCT06121167
To Examine Whether Urinary Partial Oxygen Pressure Measurements Are Indicative of the Postoperative Occurrence of Acute Kidney Injury (AKI) in Individuals Who Have Undergone Liver Transplantation
An observational study of Acute Kidney Injury, run by Inonu University.
Trial summary
Postoperative acute kidney injury (AKI) is a frequent occurrence among liver transplant recipients and results in considerable mortality and morbidity. The delayed increase in plasma creatinine levels and its susceptibility to external influences, which are utilized in the current diagnostic criteria for AKI… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- urinary partial oxygen pressure
- How many people
- 98 participants
- Where
- No sites listed yet
- Study dates
- 6 Mar 2024to 15 Jul 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
- No healthy volunteers
- Adult, Older adult
Study population: liver transplant recipients
Who may be able to join
- patients aged between 18 and 65 years
- elective liver transplantation
Who cannot join
- Patients who do not want to participate in the study,
- patients who will be transplanted due to fulminant hepatic failure,
- patients with hepatic encephalopathy,
- patients with hepatorenal or hepatopulmonary syndrome,
- patients with previous lung
- heart disease
Trial locations and contacts
No sites are listed yet.
About this study
Postoperative acute kidney injury (AKI) is a frequent occurrence among liver transplant recipients and results in considerable mortality and morbidity. The delayed increase in plasma creatinine levels and its susceptibility to external influences, which are utilized in the current diagnostic criteria for AKI, contribute to diagnostic delays. Therefore, numerous biomarkers, including KIM-1, NGAL, TIMP-2, and CYSTATIN C in plasma, along with urine partial oxygen pressure levels and NGAL, are currently under examination to identify acute kidney injury at its early stage. It is well-established that the renal medulla is highly susceptible to hypoxia, which may consequently lead to acute kidney injury. A range of studies have also demonstrated that urine partial oxygen pressure is capable of providing valuable insights into the oxygenation state of the renal medulla. Although urine oxygen pressure measurement is not commonly used, unlike blood gas analysis, urine partial oxygen pressure measurement dates back to 1964. Research among cardiopulmonary bypass patients suggests a correlation between urine partial oxygen pressure data and acute kidney injury. Therefore, we hypothesize that monitoring urine partial oxygen pressure levels may offer insight into the development of acute kidney injury in liver transplant recipients.
Read the detailed description
Ninety-eight participants, aged between 18 and 65 and scheduled for elective liver transplantation, will participate in this study. Participants under the age of 18, those who decline participation, those undergoing transplantation due to fulminant hepatic failure, those who develop hepatic encephalopathy, and patients with hepatorenal or hepatopulmonary syndrome or previous lung and heart disease will not be considered for inclusion. After obtaining ethical approval, the patients will undergo a preanaesthetic examination. Upon admission to the procedure room, standard monitoring for liver transplant recipients will be conducted. Thiopental at a dose of 5-8 mg/kg, fentanyl at 1-2 mcg/kg, lidocaine at 1 mg/kg, and vecuronium at 0 will be administered. Technical term abbreviations will be explained upon first use. The structure and language used in the text adhere to the principles of academic writing. Consistent citation and formatting features will be followed. Grammatical correctness, clear language, and logical progression of information will be prioritised. Biased language and ornamental language will be avoided. Anaesthesia will be administered at a dosage of 1 mg/kg. Following proper anaesthetic depth, intubation will take place. A urine sample (T0) and arterial blood gas will be obtained from the urinary catheter via syringe, with the aid of a blood gas analyser device before the surgical procedure. Partial pressure of oxygen will also be recorded. Before the patient departs the operating theatre, a urine sample and arterial blood gas (T1) will be retaken with a syringe and the partial oxygen level measured. Throughout the operation, data on haemodynamics, respiration, routine lab results, hourly urine output, as well as diuretic and vasopressor requirements (if applicable), will be captured. The total duration of the operation will be recorded at its conclusion. At the 18th hour post-op, a urine and arterial blood sample (T2) will be taken to measure partial oxygen pressure levels. Additionally, the NGAL level in plasma will be studied. At the 48th hour postoperative, partial oxygen pressure levels in urine and arterial blood (T3) will be measured, and the obtained data will be recorded. Please adhere to the standardised technical terminology when referencing these measurements. The quantity of urine output per hour, CSDGO score, requirement for vasopressors, diuretics, RRT, mechanical ventilation, and any subsequent complications will be documented in the intensive care unit postoperatively.
- Conditions
- Acute Kidney Injury
- Being tested
- urinary partial oxygen pressure
- Keywords
- acute kidney injrury, liver transplantation, urine partial oxygen pressure
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
urinary partial oxygen pressureDiagnostic test
arterial blood gas
| Study group | Role | What they receive |
|---|---|---|
| study group | patients with acute kidney injury Receives: Diagnostic Test: urinary partial oxygen pressure | |
| control group | patients who do not develop acute kidney injury Receives: Diagnostic Test: urinary partial oxygen pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
acute kidney injury
whether urinary oxygen partial pressure can predict acute kidney injury
Measured: first 7 days
Secondary outcomes (1)
mortality
death rate
Measured: 28. days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start6 Mar 2024 (estimated)
- Primary completion10 May 2024 (estimated)
- Study completion15 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Inonu 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Murat Bıçakcıoğlu, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06121167
- Sponsor's protocol ID
- MB1
- Status last verified
- Mar 2024
- First submitted
- 2 Nov 2023
- Last updated
- 7 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Tosun M, Ulugol H, Aksu U, Toraman F. Can Partial Oxygen Pressure of Urine be an Indicator for Tissue Perfusion? Turk J Anaesthesiol Reanim. 2019 Jun;47(3):187-191. doi: 10.5152/TJAR.2019.89083. Epub 2019 Jan 29.
PubMed 31183464Silverton NA, Lofgren LR, Hall IE, Stoddard GJ, Melendez NP, Van Tienderen M, Shumway S, Stringer BJ, Kang WS, Lybbert C, Kuck K. Noninvasive Urine Oxygen Monitoring and the Risk of Acute Kidney Injury in Cardiac Surgery. Anesthesiology. 2021 Sep 1;135(3):406-418. doi: 10.1097/ALN.0000000000003663.
PubMed 34329393Stafford-Smith M. Could Trended Oxygen Partial Pressure in the Urine Be the "ST Segment" Kidney Monitor We've Been Looking For? Anesthesiology. 2021 Sep 1;135(3):380-381. doi: 10.1097/ALN.0000000000003869. No abstract available.
PubMed 34329391
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Examine Whether Urinary Partial Oxygen Pressure Measurements Are Indicative of the Postoperative Occurrence of Acute Kidney Injury (AKI) in Individuals Who Have Undergone Liver Transplantation
- ClinicalTrials.gov ID
- NCT06121167
- Acronym / sponsor ID
- MB1
- Conditions
- Acute Kidney Injury
- Keywords
- acute kidney injrury, liver transplantation, urine partial oxygen pressure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 6 Mar 2024 (estimated)
- Primary completion
- 10 May 2024 (estimated)
- Study completion
- 15 Jul 2024 (estimated)
- First posted
- 7 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.
Postoperative acute kidney injury (AKI) is a frequent occurrence among liver transplant recipients and results in considerable mortality and morbidity. The delayed increase in plasma creatinine levels and its susceptibility to external influences, which are utilized in the current diagnostic criteria for AKI, contribute to diagnostic delays. Therefore, numerous biomarkers, including KIM-1, NGAL, TIMP-2, and CYSTATIN C in plasma, along with urine partial oxygen pressure levels and NGAL, are currently under examination to identify acute kidney injury at its early stage. It is well-established that the renal medulla is highly susceptible to hypoxia, which may consequently lead to acute kidney injury. A range of studies have also demonstrated that urine partial oxygen pressure is capable of providing valuable insights into the oxygenation state of the renal medulla. Although urine oxygen pressure measurement is not commonly used, unlike blood gas analysis, urine partial oxygen pressure measurement dates back to 1964. Research among cardiopulmonary bypass patients suggests a correlation between urine partial oxygen pressure data and acute kidney injury. Therefore, we hypothesize that monitoring urine partial oxygen pressure levels may offer insight into the development of acute kidney injury in liver transplant recipients.
Detailed description
Ninety-eight participants, aged between 18 and 65 and scheduled for elective liver transplantation, will participate in this study. Participants under the age of 18, those who decline participation, those undergoing transplantation due to fulminant hepatic failure, those who develop hepatic encephalopathy, and patients with hepatorenal or hepatopulmonary syndrome or previous lung and heart disease will not be considered for inclusion. After obtaining ethical approval, the patients will undergo a preanaesthetic examination. Upon admission to the procedure room, standard monitoring for liver transplant recipients will be conducted. Thiopental at a dose of 5-8 mg/kg, fentanyl at 1-2 mcg/kg, lidocaine at 1 mg/kg, and vecuronium at 0 will be administered. Technical term abbreviations will be explained upon first use. The structure and language used in the text adhere to the principles of academic writing. Consistent citation and formatting features will be followed. Grammatical correctness, clear language, and logical progression of information will be prioritised. Biased language and ornamental language will be avoided. Anaesthesia will be administered at a dosage of 1 mg/kg. Following proper anaesthetic depth, intubation will take place. A urine sample (T0) and arterial blood gas will be obtained from the urinary catheter via syringe, with the aid of a blood gas analyser device before the surgical procedure. Partial pressure of oxygen will also be recorded. Before the patient departs the operating theatre, a urine sample and arterial blood gas (T1) will be retaken with a syringe and the partial oxygen level measured. Throughout the operation, data on haemodynamics, respiration, routine lab results, hourly urine output, as well as diuretic and vasopressor requirements (if applicable), will be captured. The total duration of the operation will be recorded at its conclusion. At the 18th hour post-op, a urine and arterial blood sample (T2) will be taken to measure partial oxygen pressure levels. Additionally, the NGAL level in plasma will be studied. At the 48th hour postoperative, partial oxygen pressure levels in urine and arterial blood (T3) will be measured, and the obtained data will be recorded. Please adhere to the standardised technical terminology when referencing these measurements. The quantity of urine output per hour, CSDGO score, requirement for vasopressors, diuretics, RRT, mechanical ventilation, and any subsequent complications will be documented in the intensive care unit postoperatively.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | – | Diagnostic Test: urinary partial oxygen pressurepatients with acute kidney injury |
| control group | – | Diagnostic Test: urinary partial oxygen pressurepatients who do not develop acute kidney injury |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- liver transplant recipients
Key inclusion criteria (2 listed)
- patients aged between 18 and 65 years
- elective liver transplantation
Key exclusion criteria (6 listed)
- Patients who do not want to participate in the study,
- patients who will be transplanted due to fulminant hepatic failure,
- patients with hepatic encephalopathy,
- patients with hepatorenal or hepatopulmonary syndrome,
- patients with previous lung
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 |
|---|---|---|
| urinary partial oxygen pressurearterial blood gas | Diagnostic test | control group, study group |
Primary outcome
acute kidney injury
Time frame: first 7 days
whether urinary oxygen partial pressure can predict acute kidney injury
1 secondary outcome
mortality
Time frame: 28. days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2024.
- Background: PubMed 31183464Tosun M, Ulugol H, Aksu U, Toraman F. Can Partial Oxygen Pressure of Urine be an Indicator for Tissue Perfusion? Turk J Anaesthesiol Reanim. 2019 Jun;47(3):187-191. doi: 10.5152/TJAR.2019.89083. Epub 2019 Jan 29.
- Background: PubMed 34329393Silverton NA, Lofgren LR, Hall IE, Stoddard GJ, Melendez NP, Van Tienderen M, Shumway S, Stringer BJ, Kang WS, Lybbert C, Kuck K. Noninvasive Urine Oxygen Monitoring and the Risk of Acute Kidney Injury in Cardiac Surgery. Anesthesiology. 2021 Sep 1;135(3):406-418. doi: 10.1097/ALN.0000000000003663.
- Results publication: PubMed 34329391Stafford-Smith M. Could Trended Oxygen Partial Pressure in the Urine Be the "ST Segment" Kidney Monitor We've Been Looking For? Anesthesiology. 2021 Sep 1;135(3):380-381. doi: 10.1097/ALN.0000000000003869. No abstract available.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury, run by Inonu 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 2 inclusion and 6 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 7 Mar 2024. 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 murat bıçakcıoğlu (05327901791, drmuratft@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
acute kidney injury (time frame: first 7 days). 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 NCT06121167, which also lists 3 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 7 Mar 2024; AzTrials last refreshed its copy on 1 Nov 2026.