Diagnostic Performance of Two Tools | NCT05268211

Studies
Diagnostic Performance of Two Tools

NCT05268211

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

Mar 7, 2022Actual

Enrollment

130Estimated

Phase

Not provided

Conditions

Acute Kidney Injury

Interventions

urinary oxygen partial pressure

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

Feb 2022

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 1, 2022Estimated

Primary Completion Date

Mar 1, 2024Estimated

Completion Date

Dec 1, 2024Estimated

First Submitted Date

Feb 15, 2022

First Submission Date that Met QC Criteria

Feb 24, 2022

First Posted Date

Mar 7, 2022Actual

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

Feb 24, 2022

Last Update Posted Date

Mar 7, 2022Actual

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

3 Days

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

130Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
urinary oxygen partial pressure	Diagnostic Test	measuring urinary oxygen partial pressure and measuring US Doppler renal resistive index

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of acute kidney injury	Incidence of AKI according to AKIN criteria	up to 48 hours
Urinary oxygen partial pressure	Urinary oxygen partial pressure measured in mmHg at induction, before rewarming and in the ICU	up to 48 hours
Renal resistive index	Renal resistive index measured at induction and in the ICU	up to 48 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients undergoing on-pump coronary artery bypass graft (CABG) surgery of both sexes

Exclusion Criteria:

Age less than 18 years old and more than 80 years old. Patients with (CKD), chronic liver disease, heart failure, and not on diuretics or other medications that may affect renal function.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Enrollment of patients will be done through Assiut university Heart hospital after approval from the local ethics committee of the Faculty of Medicine, Assiut University

Sampling Method

Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D058186	Acute Kidney Injury

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided