Association Between Venous Excess Ultrasound Grading System and Acute Kidney Injury in the ICU Population (VExUS ICU)

The Association Between Venous Excess Ultrasound, the Lung Ultrasound Score and Acute Kidney Injury and Death in the Intensive Care Unit Population

Fluid resuscitation is one of the cornerstones of treatment in ICU patients. Nonetheless, excessive fluid administration can lead to fluid overload which has been associated with worse outcomes in the ICU. To prevent this, assessments of fluid responsiveness are commonly employed. However, fluid responsiveness does not take fluid tolerance into account. Fluid tolerance is the idea that a patient might still be fluid responsive but might already be at risk of the detrimental effects of fluid therapy. Recent developments in point of care ultrasound e.g. the Venous excess ultrasound might help identify patients at risk of fluid overload. However its association with patient relevant outcomes in the ICU remains unclear.

Study Overview

• Status: Recruiting
• Conditions: Kidney Injury; Fluid Overload; Make-30

Detailed Description

This study will investigate the association between the venous excess ultrasound grading system (VExUS) and patient relevant outcomes such as acute kidney injury, mortality and length of stay.

A secondary analysis is planned where the association between VExUS and the lung ultrasound score will be investigated

• Study Type: Observational
• Enrollment (Estimated): 136

Contacts and Locations

• Study Contact: Name: Pieter R Tuinman, PhD; Phone Number: 0204444444; Email: p.tuinman@amsterdamumc.nl
• Study Contact Backup: Name: P Klompmaker, MSc; Phone Number: 0204444444; Email: p.klompmaker@amsterdamumc.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All cricitally ill patients who are expected to be admitted to the ICU for more than 24 hours and who do not meet the exclusion criteria

Description

Inclusion Criteria:

• all patients admitted to the ICU 18 years or older expected to stay in the ICU for more than 24 hours

Exclusion Criteria:

• any obstruction between the righ atrium and structures assessed by VExUS
• a medical history of: Major cardiac shunts (e.g. atrial septum defect), Tricuspid regurgitation, dialysis, portal hypertension, pulmonary hypertension, interstitial lung disease, recipients of a kidney of liver transplant.
• patients in whom an ultrasound assesment is unfeasible e.g. a BMI over 40

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of acute kidney injury	Clinically relevant acute kidney injury in the ICU: a 200% rise in creatinine or the use of renal replacement therapy	within 30 days of admission to the ICU
Mortality	death of all causes	within 30 days of admission to the ICU
Rate of MAKE-30	a composite endpoint of mortality and acute kidney injury ( including renal replacement therapy)	within 30 days of admission to the ICU

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lung ultrasound score	a score for lung aeration as assessed by ultrasound ranging from 0 to 36 where 0 is the normal physiological state	maximum of 3 times during the first 7 days of admission
Cardiac function as assed by ultrasound	determined by eyeballing and measurement of the tricuspid annular plane systolic excursion (>16 is normal)	maximum of 3 times during the first 7 days of admission

Collaborators and Investigators

• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Estimated): September 5, 2024
• Study Completion (Estimated): September 5, 2024

Study Registration Dates

• First Submitted: March 13, 2024
• First Submitted That Met QC Criteria: September 4, 2024
• First Posted (Estimated): September 5, 2024

Study Record Updates

• Last Update Posted (Estimated): September 5, 2024
• Last Update Submitted That Met QC Criteria: September 4, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Wounds and Injuries; Acute Kidney Injury
• Other Study ID Numbers: 2020.01111

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No