Gravity in Flow: Automating Diuresis

The goal of this randomized clinical trial is to evaluate the accuracy of automated urine output monitoring using the FlowSure system compared to standard manual urine monitoring in hospitalized patients with an indwelling urinary catheter. The main questions it aims to answer are: How accurate is the automated FlowSure monitoring compared with manual urine monitoring over defined time intervals (8-hour nursing shifts and 24-hour periods)? Does the automated system improve completeness of hourly urine output registration compared with manual documentation? Researchers will compare patients monitored with the automated FlowSure device to those monitored using the manual method to determine whether automation provides more accurate and complete diuresis data. Participants will: Be adult patients admitted to the hospital with a urinary catheter inserted for routine medical reasons (not related to this study). In Part B, be randomized to either manual urine monitoring or automated FlowSure monitoring for defined time intervals. There is no direct benefit to participants. The potential societal benefit lies in improving the accuracy, efficiency, and safety of diuresis monitoring through automation. The risks are minimal and limited to use of the FlowSure device in addition to, or instead of, standard monitoring; no additional procedures are performed.

NCT Number	NCT07384325
Lead Sponsor	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Conditions	Automated Urine Monitoring, Urine Output, Fluid Balance, Urinary Catheters, Diuresis
Enrollment	75 participants
Start Date	2025-06-02
Primary Completion	2026-01-15 (estimated)
Study Completion	2026-03-10 (estimated)
Updated on ClinicalTrials.gov	2026-03-18