Brief Summary

Fluid overload is associated with adverse outcomes in patients with severe acute kidney injury. It remains unclear if fluid overload is merely a marker of disease severity or if organ congestion is a mediator of complications. Point-of-care ultrasound could be a modality used to assess organ congestion and its clinical implications. The objective of this study is to determine whether ultrasound markers of organ congestion are associated with major adverse kidney events in critically ill patients with severe acute kidney injury.

Trial Health

On Track

Trial Health Score

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

Enrollment

125

participants targeted

Target at P50-P75 for all trials

Timeline

Completed

Started Sep 2018

Longer than P75 for all trials

Geographic Reach

2 countries

6 active sites

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

4 years study duration

Study Start

First participant enrolled

September 4, 2018

Completed

1 year until next milestone

First Submitted

Initial submission to the registry

September 17, 2019

Completed

2 days until next milestone

First Posted

Study publicly available on registry

September 19, 2019

Completed

2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed

8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed

Last Updated

November 14, 2022

Status Verified

November 1, 2022

Enrollment Period

3.3 years

First QC Date

September 17, 2019

Last Update Submit

November 11, 2022

Conditions

Acute Kidney Injury Fluid Overload Ultrasonography

Keywords

Point-Of-Care ultrasoundDopplerMajor adverse kidney eventsPortal flow pulsatilityIVC ultrasoundCardiac ultrasoundRight ventricular failureIntensive care

Outcome Measures

Primary Outcomes (1)

Number of participants with major adverse kidney events at 30 days
Either death, receipt of renal replacement therapy or sustained loss of kidney function (new onset of estimated glomerular filtration rate (eGFR) \< 60 or, if pre-existing eGFR \< 60, 25% or greater decline in eGFR)
30 days

Secondary Outcomes (9)

Rate of in-hospital death
30 days
Number of participants with renal replacement therapy dependence at 30 days
30 days
Number of participants with sustained loss of kidney function at 30 days
30 days
Ventilation-free days through day 30
30 days
Intensive care unit (ICU)-free days through day 30
30 days
+4 more secondary outcomes

Other Outcomes (1)

Hemodynamic instability during renal replacement therapy
7 days

Study Arms (1)

New onset of stage ≥2 acute kidney injury

Either: 1. A ≥ 2-fold increase in serum creatinine OR 2. A serum creatinine ≥ 354 μmol/L with evidence of a minimum increase of 27 μmol/L OR 3. Urine output \< 6.0 mL/kg over the preceding 12 hours OR 4. Initiation of RRT for severe acute kidney injury less than 72 hours before recruitment

Diagnostic Test: Portal vein flowDiagnostic Test: Intra-renal flowDiagnostic Test: Hepatic vein flowDiagnostic Test: Pulmonary B-linesDiagnostic Test: Dimensions of the inferior vena cavaDiagnostic Test: Left ventricular functionDiagnostic Test: Right ventricular function