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

NCT06585722 | Recruiting

• 1 other identifier: 2020.01111
• Study Type: observational
• Target: 136
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fluid Overload; Kidney Injury; Make-30

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Lung ultrasound score

  maximum of 3 times during the first 7 days of admission

• Cardiac function as assed by ultrasound

  maximum of 3 times during the first 7 days of admission

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Amsterdam UMC

Amsterdam, North Holland, 1081HV, Netherlands

RECRUITING

MeSH Terms

Conditions

Edema

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Pieter R Tuinman, PhD

CONTACT

0204444444; p.tuinman@amsterdamumc.nl

P Klompmaker, MSc

CONTACT

0204444444; p.klompmaker@amsterdamumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. P.R. Tuinman, Principal Investigator

Study Record Dates

• First Submitted: March 13, 2024
• First Posted: September 5, 2024
• Study Start: February 1, 2023
• Primary Completion: September 5, 2024
• Study Completion: September 5, 2024
• Last Updated: September 5, 2024

Record last verified: 2024-09

Locations

NL (1)