NCT04470661

Brief Summary

It is aimed to determine prerenal, renal and postrenal diagnoses of patients with acute kidney injury with POCUS performed in the emergency department. Patients who presented to the emergency department and who have acute kidney injury (AKI) according to the KDIGO criteria will be evaluated and patients diagnosed with AKI will be included in the study. The diagnostic accuracy of POCUS with the AKI etiologies of the patients will be evaluated.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
130

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2020

Shorter than P25 for all trials

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 9, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 14, 2020

Completed
18 days until next milestone

Study Start

First participant enrolled

August 1, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2021

Completed
Last Updated

March 16, 2022

Status Verified

March 1, 2022

Enrollment Period

12 months

First QC Date

July 9, 2020

Last Update Submit

March 15, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • The diagnostic accuracy of POCUS in the patients with AKI

    One year

Interventions

UltrasonographyDIAGNOSTIC_TEST

Point-of-care ultrasound: 1. Kidney length and echogenity, 2. Bladder scanning 3. VCI measures 4. Lung B lines and effusion 5. Cardiac measurements; EF, TAPSE, TR Vmax, Diameters, LV filling pressures

Eligibility Criteria

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

Patients with acute kidney injury diagnosed in the ED.

You may qualify if:

  • AKI diagnosis according to KDIGO criteria

You may not qualify if:

  • Patients with end stage renal failure,
  • Failure to perform POCUS in the first two hours of presentation of patient,
  • Those with renal malignancy,
  • Pregnant women,
  • Renal transplantation patients,
  • Patients with a single kidney,
  • Those with polycystic kidney disease,
  • Patients with nephrostomy,
  • Patients who are referred from another center,
  • Unable to perform adequate imaging,
  • Patients who do not give consent for the study will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazi University Facaulty of Medicine

Ankara, Turkey (Türkiye)

Location

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 Officials

  • Mehmet Aslaner, MD

    Gazi University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assoc. Prof.

Study Record Dates

First Submitted

July 9, 2020

First Posted

July 14, 2020

Study Start

August 1, 2020

Primary Completion

July 30, 2021

Study Completion

July 30, 2021

Last Updated

March 16, 2022

Record last verified: 2022-03

Locations