Can Urinary Partial Oxygen Pressure be an Indicator of Ac... | NCT06124105

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

NCT06124105

Sponsor

Inonu University

Status

Unknown status

Last Update Posted

Mar 7, 2024Actual

Enrollment

68Estimated

Phase

Not Applicable

Conditions

Acute Kidney Injury
Sepsis

Interventions

arterial blood gases

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 6, 2024Estimated

Primary Completion Date

Oct 15, 2024Estimated

Completion Date

Dec 15, 2024Estimated

First Submitted Date

Nov 6, 2023

First Submission Date that Met QC Criteria

Nov 6, 2023

First Posted Date

Nov 9, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 6, 2024

Last Update Posted Date

Mar 7, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Murat Bıçakcıoğlu, Principal Investigator, Inonu UniversityPrincipal Investigator

Lead Sponsor

Inonu UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

68Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
urine PO2	Other		Diagnostic Test: arterial blood gases

Interventions

Name	Type	Description	Arm Group Labels	Other Names
arterial blood gases	Diagnostic Test	measurement of partial oxygen pressure in urine by arterial blood gas device	urine PO2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
acute kidney injury	urine partial oxygen pressure in arterial blood gases	first 5 days

Secondary Outcomes

Measure	Description	Time Frame
mortality	death rate	28. days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients admitted to intensive care unit with sepsis

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
murat bıçakcıoğlu	Contact	05327901791		drmuratft@gmail.com

Overall Officials

Not provided

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
31336370	Background	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.
34329393	Background	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.

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

ID	Term
D001774	Blood Chemical Analysis
D019963	Clinical Chemistry Tests
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures