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Not yet recruitingNCT06124105Updated Mar 7, 2024

Can Urinary Partial Oxygen Pressure be an Indicator of Acute Kidney Injury in Patients With Sepsis?

An interventional study of arterial blood gases in Acute Kidney Injury and Sepsis, sponsored by Inonu University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-07.

Sponsored by Inonu University · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Primary completion was expected by Oct 2024, 1 year 11 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
68
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

Patients hospitalised in the intensive care unit with a diagnosis of sepsis will be followed up for the development of ABH. This follow-up will be performed for 5 days after hospitalisation. During this period, patients will be sampled for NGAL 5 times in total, once every day. PuO2 will be sampled daily to determine PuO2 and to observe the development of AKI, and in cases of hypotension where the mean arterial pressure falls below 65 mmHg or in cases of severe acidosis, extra will be sampled at least 5 times, once every day. PuO2 will be analysed in the blood gas device and PuO2 value will be recorded. For NGAL analysis, patient blood will be collected in ETDA tubes and stored at -80 °C until analysis. NGAL will then be measured by turbidimetric imminoassay method. The comorbidities of the patients will be questioned and recorded, the types and amounts of fluids taken, whether they received blood and blood products, and if so, which product and how much they received will be recorded. APACHI II score and SOFA scores of the patients at hospitalisation will be recorded. GCS, whether mechanical ventilation support is provided or not, if any, ventilation method, mode and ventilation parameters will be recorded. In addition to these, mean arterial pressure, pulse, temperature, SpO2, FiO2 values will be recorded clinically. Haemoglobin, haemotocrit, platelets, bun, creatinine, biluribins, liver function tests and arterial blood gas will be recorded in the laboratory. In addition, whether the patients have ARDS, whether they are receiving renal replacement therapy and if so, the prescription and ultrasonography findings will be recorded.

02

Conditions studied

  • Acute Kidney Injury
  • Sepsis

Keywords

  • acute kidney injrury, sepsis, urine parcial oxygen pressure
03

In context

Sepsis

1,899 studies on the registry are indexed under Sepsis; 458 are open to participants now.

This study's planned enrollment of 68 is below the median of 105 across 893 interventional studies indexed under Sepsis.

Browse Sepsis studies →

Lead sponsor

Inonu University is the lead sponsor of 375 studies on the registry; 86 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • patients admitted to intensive care unit with sepsis

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
68 participants (estimated)

Study arms

  • Other
    urine PO2

    Diagnostic Test: arterial blood gases

Interventions

  • Diagnostic testarterial blood gases

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

06

What researchers measure

Primary outcomes

  1. acute kidney injury

    urine partial oxygen pressure in arterial blood gases

    Time frame: first 5 days

Secondary outcomes

  1. mortality

    death rate

    Time frame: 28. days

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 31336370 ↗
  • 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. PubMed 34329393 ↗
  • 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. PubMed 33977810 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 7, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06124105
Lead sponsor
Inonu University
Responsible party
Murat Bıçakcıoğlu (Principal Investigator, Inonu University) — Principal investigator
First posted
Nov 9, 2023
Start date
Mar 6, 2024 (estimated)
Primary completion
Oct 15, 2024 (estimated)
Completion
Dec 15, 2024 (estimated)
Last update
Mar 7, 2024

Study contacts

murat bıçakcıoğlu
Contact
drmuratft@gmail.com
05327901791

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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