NCT06121167

Brief 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, 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
98

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2024

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 7, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

March 6, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2024

Completed
Last Updated

March 7, 2024

Status Verified

March 1, 2024

Enrollment Period

2 months

First QC Date

November 2, 2023

Last Update Submit

March 6, 2024

Conditions

Keywords

acute kidney injruryliver transplantationurine partial oxygen pressure

Outcome Measures

Primary Outcomes (1)

  • acute kidney injury

    whether urinary oxygen partial pressure can predict acute kidney injury

    first 7 days

Secondary Outcomes (1)

  • mortality

    28. days

Study Arms (2)

study group

patients with acute kidney injury

Diagnostic Test: urinary partial oxygen pressure

control group

patients who do not develop acute kidney injury

Diagnostic Test: urinary partial oxygen pressure

Interventions

arterial blood gas

control groupstudy group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

liver transplant recipients

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 31183464BACKGROUND
  • Silverton 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.

    PMID: 34329393BACKGROUND
  • Stafford-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.

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Central Study Contacts

murat bıçakcıoğlu

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asistant prof

Study Record Dates

First Submitted

November 2, 2023

First Posted

November 7, 2023

Study Start

March 6, 2024

Primary Completion

May 10, 2024

Study Completion

July 15, 2024

Last Updated

March 7, 2024

Record last verified: 2024-03