NCT04948710

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2021

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

June 25, 2021

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

June 28, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 2, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 25, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 25, 2022

Completed
Last Updated

January 31, 2023

Status Verified

January 1, 2023

Enrollment Period

1.3 years

First QC Date

June 28, 2021

Last Update Submit

January 29, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • The diagnostic accuracy of sonographic venous Doppler imaging in the patients with AKI

    1 year

Interventions

SonographyDIAGNOSTIC_TEST

Sonographic Venous Doppler Imaging

Eligibility Criteria

Age18 Years - 110 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Emergency department patients with acute kidney injury

You may qualify if:

  • AKI diagnosis

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazi University Facaulty of Medicine

Ankara, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

June 28, 2021

First Posted

July 2, 2021

Study Start

June 25, 2021

Primary Completion

October 25, 2022

Study Completion

October 25, 2022

Last Updated

January 31, 2023

Record last verified: 2023-01

Locations