NCT04095143

Ultrasound Markers of Organ Congestion in Severe Acute Kidney Injury

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 125 (actual)
• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM) · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Background: 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 direct mediator of complications. Point-of-care ultrasound could be a modality used to assess organ congestion and its clinical implications. Objective: To determine whether ultrasound markers of organ congestions are associated with major adverse kidney events and other adverse clinical outcomes. Study design: A cohort of critically ill patients with a new onset of severe acute kidney injury will undergo repeated ultrasound assessments to detect the presence of the following markers: * Portal flow pulsatility on pulse-wave Doppler * Discontinuous intra-renal venous flow on pulse-wave Doppler * Abnormal hepatic vein waveform on pulse wave Doppler * Presence of pulmonary B-line artifacts on 2D lung ultrasound * Presence of dilated and non-collapsible inferior vena cava on 2D ultrasound * Presence of systolic right ventricular dysfunction * Presence of systolic left ventricular dysfunction Clinical outcomes will be collected for up to 90 days after recruitment. Perspective: An approach targeting the resolution of organ congestion might improve the prognosis in patients with severe acute kidney injury. Identifying clinically relevant markers of organ congestion is a precursor to the design of future interventional trials investigating personalized fluid balance management.

Conditions

• Acute Kidney Injury
• Fluid Overload
• Ultrasonography

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Portal vein flow	Doppler assessment performed on day 0, 3 and 7.
DIAGNOSTIC_TEST	Intra-renal flow	Doppler assessment performed on day 0, 3 and 7.
DIAGNOSTIC_TEST	Hepatic vein flow	Doppler assessment performed on day 0, 3 and 7.
DIAGNOSTIC_TEST	Pulmonary B-lines	Ultrasound assessment of performed on day 0, 3 and 7.
DIAGNOSTIC_TEST	Dimensions of the inferior vena cava	Ultrasound assessment of performed on day 0, 3 and 7.
DIAGNOSTIC_TEST	Left ventricular function	Ultrasound assessment of performed on day 0, 3 and 7.
DIAGNOSTIC_TEST	Right ventricular function	Ultrasound assessment of performed on day 0, 3 and 7.

Timeline

• Start date: 2018-09-04
• Primary completion: 2022-01-01
• Completion: 2022-09-01
• First posted: 2019-09-19
• Last updated: 2022-11-14

Locations

6 sites across 2 countries: United States, Canada