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

March 6, 2024 updated by: Murat Bıçakcıoğlu, Inonu University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

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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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
98

Contacts and Locations

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Study Contact

Study Contact

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Participation Criteria

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Eligibility Criteria

Eligibility Criteria

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Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

liver transplant recipients

Description

Inclusion Criteria:

  • patients aged between 18 and 65 years
  • elective liver transplantation

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
study group
patients with acute kidney injury
Diagnostic test: urinary partial oxygen pressure
arterial blood gas
control group
patients who do not develop acute kidney injury
Diagnostic test: urinary partial oxygen pressure
arterial blood gas

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
acute kidney injury
Time Frame: first 7 days
whether urinary oxygen partial pressure can predict acute kidney injury
first 7 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
mortality
Time Frame: 28. days
death rate
28. days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Inonu University

Publications and helpful links

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General Publications

Study record dates

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Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 6, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 10, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 15, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 2, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 2, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 7, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 7, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 6, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MB1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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