Sonographic Venous Doppler Imaging in Acute Kidney Injury | NCT04948710

Studies
Sonographic Venous Doppler Imaging in Acute Kidney Injury

NCT04948710

Sponsor

Gazi University

Status

Completed

Last Update Posted

Jan 31, 2023Actual

Enrollment

150Actual

Phase

Not provided

Conditions

Acute Kidney Injury

Interventions

Sonography

Countries

Turkey (Türkiye)

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

Jan 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 25, 2021Actual

Primary Completion Date

Oct 25, 2022Actual

Completion Date

Oct 25, 2022Actual

First Submitted Date

Jun 28, 2021

First Submission Date that Met QC Criteria

Jun 28, 2021

First Posted Date

Jul 2, 2021Actual

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

Jan 29, 2023

Last Update Posted Date

Jan 31, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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 first presentations of patients with acute kidney injury (AKI) are usually to the emergency departments. While the mortality rate is 5-10% in uncomplicated AKI, it is between 40-90% in patients hospitalized in the intensive care unit. Therefore early diagnosis and treatment of AKI in the emergency department is important in terms of morbidity and mortality.

Sonographic evaluation of the venous system (hepatic, portal and renal vein) may be useful for diagnosis. Studies conducted so far have generally been based on predicting cardiorenal AKI and renal poor outcomes and have been designed in general ICU conditions.

In this study, the investigators aimed to determine the diagnostic value of sonographic venous Doppler imaging in terms of distinguishing subgroups of AKI in patients presented to the emergency department with AKI.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

150Actual

Name	Type	Description	Arm Group Labels	Other Names
Sonography	Diagnostic Test	Sonographic Venous Doppler Imaging

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The diagnostic accuracy of sonographic venous Doppler imaging in the patients with AKI		1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

AKI diagnosis

Exclusion Criteria:

Patients

with end-stage renal failure (stage 4),
who received 500 mL IV fluid or 40 mg diuretics,
who are pregnant,
with renal transplantation,
with cirrhosis and liver malignancy,
with postrenal AKI,
who were referred from another center after starting treatment,
who do not give consent for the study.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

110 Years

Standard Ages

AdultOlder Adult

Study Population

Emergency department patients with acute kidney injury

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Gazi University Facaulty of Medicine		Ankara			Turkey (Türkiye)

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
38355289	Derived	Aslaner MA, Helvaci O, Haycock K, Kilicaslan I, Yasar E, Cerit MN, Sendur HN, Guz G, Demircan A. Diagnostic accuracy of venous system ultrasound for subtypes of acute kidney injury. Emerg Med J. 2024 Apr 22;41(5):304-310. doi: 10.1136/emermed-2023-213241.

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

ID	Term
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis