NCT06124105

Brief Summary

The ability of bladder urinary partial pressure, measured as a reflection of renal medullary oxygen tension, which is an indicator of the development of acute kidney injury (AKI), to predict the development of AKI at an early stage.

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
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 6, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 9, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

March 6, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2024

Completed
Last Updated

March 7, 2024

Status Verified

March 1, 2024

Enrollment Period

7 months

First QC Date

November 6, 2023

Last Update Submit

March 6, 2024

Conditions

Keywords

acute kidney injrury, sepsis, urine parcial oxygen pressure

Outcome Measures

Primary Outcomes (1)

  • acute kidney injury

    urine partial oxygen pressure in arterial blood gases

    first 5 days

Secondary Outcomes (1)

  • mortality

    28. days

Study Arms (1)

urine PO2

OTHER
Diagnostic Test: arterial blood gases

Interventions

arterial blood gasesDIAGNOSTIC_TEST

measurement of partial oxygen pressure in urine by arterial blood gas device

urine PO2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients admitted to intensive care unit with sepsis

You may not qualify if:

  • Causing an infection other than sepsis at the time of admission
  • Acute renal failure at the time of admission
  • Having a creatinine value above 1.5 mg/dL at the time of admission
  • Previously known chronic renal failure or being on a routine dialysis programme (receiving renal replacement therapy)
  • Having one kidney
  • Having another known kidney disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Osawa EA, Cutuli SL, Bitker L, Canet E, Cioccari L, Iguchi N, Lankadeva YR, Eastwood GM, Evans RG, May CN, Bellomo R. Effect of Furosemide on Urinary Oxygenation in Patients with Septic Shock. Blood Purif. 2019;48(4):336-345. doi: 10.1159/000501512. Epub 2019 Jul 23.

    PMID: 31336370BACKGROUND
  • 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
  • Evans RG, Cochrane AD, Hood SG, Iguchi N, Marino B, Bellomo R, McCall PR, Okazaki N, Smith JA, Zhu MZ, Ngo JP, Noe KM, Martin A, Thrift AG, Lankadeva YR, May CN. Dynamic responses of renal oxygenation at the onset of cardiopulmonary bypass in sheep and man. Perfusion. 2022 Sep;37(6):624-632. doi: 10.1177/02676591211013640. Epub 2021 May 12.

    PMID: 33977810BACKGROUND

MeSH Terms

Conditions

Acute Kidney InjurySepsis

Interventions

Blood Gas Analysis

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Blood Chemical AnalysisClinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisRespiratory Function TestsDiagnostic Techniques, Respiratory SystemInvestigative Techniques

Central Study Contacts

murat bıçakcıoğlu

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: study group: patients who develop aki in sepsis
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 6, 2023

First Posted

November 9, 2023

Study Start

March 6, 2024

Primary Completion

October 15, 2024

Study Completion

December 15, 2024

Last Updated

March 7, 2024

Record last verified: 2024-03