NCT06889116

Brief Summary

Introduction Renal perfusion is dependent on the renal perfusion pressure across the renal capillaries. Venous congestion due to excess fluid therapy can drastically reduce the renal perfusion pressure in spite of a normal mean arterial pressure. Increasing cumulative fluid balance during the ICU stay has been found to be associated with negative outcomes including acute kidney injury (AKI) and hospital mortality. Venous excess ultrasound (VExUS) to assess the Doppler studies of renal, hepatic and portal veins along with the inferior venacava has been shown to reliably predict the incidence of AKI in certain ICU patient population more specifically in cardiorenal syndrome. The aim of this study was to correlate the incidence of AKI and VExUS scores in a mixed ICU population and hence determine the contribution of venous congestion on the causation of AKI in a general ICU. Methods: The patients included who have AKI at admission or developed AKI during their ICU stay were included. The definition of AKI used for this study was as defined by Kidney Disease: Improving Global Outcomes (KDIGO). Point of care VExUS scans were done on each patient at inclusion (day 0), then each day for a total of 4 days (day 1, 2 and 3), till initiation of renal replacement therapy, death or discharge form the ICU. Correlation between VExUS grades and creatinine clearances was explored as the primary objective.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2023

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

Study Start

First participant enrolled

May 15, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 7, 2024

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 11, 2024

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 15, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 21, 2025

Completed
Last Updated

March 21, 2025

Status Verified

March 1, 2025

Enrollment Period

8 months

First QC Date

March 15, 2025

Last Update Submit

March 20, 2025

Conditions

Keywords

VExUSAcute Kidney InjuryCumulative fluid balancePoint of Care Ultrasound

Outcome Measures

Primary Outcomes (1)

  • To determine correlation between the VExUS score with creatinine clearance.

    At the end of Day 3 or initiation of renal replacement therapy or resolution of AKI, death or discharge from the ICU. whichever came first.

Study Arms (1)

Patients with AKI

Patients who are admitted with the diagnosis of AKI or develop AKI during their ICU stay

Eligibility Criteria

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

Patients who had AKI at the time of admission or who developed AKI during their ICU stay were screened for inclusion.

You may qualify if:

  • Age ≥18 years
  • Admitted to the adult ICUs of TUTH (ICU A and ICU B)
  • Admitting diagnosis of AKI or who developed AKI during their ICU stay

You may not qualify if:

  • Pregnancy
  • Diagnosed case of chronic kidney disease
  • Diagnosed case of cirrhosis/ portal hypertension
  • Arrhythmias which would interfere with the acquisition and interpretation of the Doppler waveforms
  • Inferior venacava thrombus
  • Poor window for assessment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tribhuvan University Teaching Hospital

Mahārājgañj, Bagmati, 44600, Nepal

Location

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

March 15, 2025

First Posted

March 21, 2025

Study Start

May 15, 2023

Primary Completion

January 7, 2024

Study Completion

January 11, 2024

Last Updated

March 21, 2025

Record last verified: 2025-03

Locations