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NCT Number: NCT06585722

Association Between Venous Excess Ultrasound Grading System and Acute Kidney Injury in the ICU 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.

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Key information

Conditions

Fluid Overload Edema Kidney Injury Make-30 Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Amsterdam UMC

Amsterdam, North Holland, 1081HV, Netherlands

Location status: Recruiting

Location contact

P R tuinman, PhD

CONTACT

[email protected]

020 444 4444

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Rate of acute kidney injury

    Time frame: within 30 days of admission to the ICU

    Clinically relevant acute kidney injury in the ICU: a 200% rise in creatinine or the use of renal replacement therapy

  2. Mortality

    Time frame: within 30 days of admission to the ICU

    death of all causes

  3. Rate of MAKE-30

    Time frame: within 30 days of admission to the ICU

    a composite endpoint of mortality and acute kidney injury ( including renal replacement therapy)

Other outcomes

  1. Lung ultrasound score

    Time frame: maximum of 3 times during the first 7 days of admission

    a score for lung aeration as assessed by ultrasound ranging from 0 to 36 where 0 is the normal physiological state

  2. Cardiac function as assed by ultrasound

    Time frame: maximum of 3 times during the first 7 days of admission

    determined by eyeballing and measurement of the tricuspid annular plane systolic excursion (>16 is normal)

Study contacts

Contact information is provided by the study sponsor or research team.

P Klompmaker, MSc

CONTACT

[email protected]

0204444444

Pieter R Tuinman, PhD

CONTACT

[email protected]

0204444444

Sponsors and collaborators

Lead sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Other

Registry information

Official study title

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

Acronym: VExUS ICU

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 5, 2024
Registry last updated
Sep 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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