HOspitalized Patients and Clinical flUid Status, Assessment Using Point Of Care UltraSound

NCT06379347 | Recruiting

• 1 other identifier: FZ 23/41
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Point of care ultrasound (POCUS) of the inferior vena cava (IVC) is a tool for assessing volume status through ultrasonography. Using a point of care ultrasound device, the physician can perform an ultrasound of the vena cava at the bedside. Previous research has demonstrated a correlation between right atrial pressure and the vena cava's diameter. Nonetheless, the majority of research has been conducted in critically ill populations to predict fluid responsiveness in patients with more complex hemodynamics. There is limited data available on the value of IVC ultrasound in the sub-acute setting on the regular ward for clinical decision-making regarding whether a patient is hypovolemic or hypervolemic. This study's objective is to assess the diagnostic utility of point-of-care ultrasonography of the IVC, by using a standardized methodology, performed by qualified ward physicians in a conventional nursing ward.

Conditions

Volume Status

Outcome Measures

Primary Outcomes (1)

• Volume status

  Depleted, overloaded, or normal volume status at baseline, determined 48 hours after performing the ultrasound.

  48 hours

Interventions

POCUS performed on clinical indication DIAGNOSTIC_TEST

POCUS performed on clinical indication

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

Adult patients admitted to the general ward with a clinical indication for performing VCI ultrasound.

You may qualify if:

• Patient is over 18 years old.
• Patient has a clinical indication for making a IVC ultrasound.
• Patient is admitted until at least 24 hours after the first ultrasound.

You may not qualify if:

• Patients who are using vasopressors at the time of the ultrasound.
• Patients who require invasive or non-invasive (optiflow, CPAP, BPAP) ventilation.

Sponsors & Collaborators

• Flevoziekenhuis: lead

Study Sites (1)

Flevoziekenhuis

Almere Stad, Netherlands

RECRUITING

Related Publications (1)

• Kircher BJ, Himelman RB, Schiller NB. Noninvasive estimation of right atrial pressure from the inspiratory collapse of the inferior vena cava. Am J Cardiol. 1990 Aug 15;66(4):493-6. doi: 10.1016/0002-9149(90)90711-9.

  PMID: 2386120 BACKGROUND

Study Officials

• Koen de Heer, MD PhD

  Flevoziekenhuis

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Koen de Heer, MD PhD

CONTACT

+31 36 8688888; psp@flevoziekenhuis.nl

Didier Collard, MD PhD

CONTACT

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2024
• First Posted: April 23, 2024
• Study Start: February 28, 2024
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: October 23, 2024

Record last verified: 2024-10

Locations

NL (1)