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Gravity of Flow - The Flowsure clinical validation study protocol

Gravity of Flow - The Flowsure clinical validation study protocol - Gravity of Flow

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON56545
Enrollment
75
Registered
2023-10-03
Start date
2024-04-15
Completion date
Unknown
Last updated
2026-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

diuresis urination

Interventions

In part A patient will undergo double urine monitoring as they receive both the manual urine monitor and automated Flowsure monitor. In part B patients will be randomized to monitoring with the manu

Sponsors

Amsterdam UMC
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - 18 years and older - Currently hospitalized - Currently for medical treatment (unrelated to the study have an urine catheter inserted - Willing and able to provide informed consent

Exclusion criteria

Exclusion criteria: Patients who: - Do not have a urine catheter inserted - Are known to have chronically no diuresis (e.g. patients on dialysis).

Design outcomes

Primary

MeasureTime frame
The primary outcome event in Part A will be the accuracy of urine measurement over two set time interval (a nursing shift of 8 hours and a full 24 hours period) using manual monitoring and automated monitoring. The gold standard will be the total urine production measured in a measuring cup by draining the collection bag. The primary outcome in part B of the study will accuracy of measurement over a set time interval (a nursing shift of 8 hours and a full 24 hours period) using manual monitoring and automated monitoring. Additional the completeness of the hourly diuresis registration will be compared between the manual and automated measurement groups.

Countries

Netherlands

Contacts

Public ContactTF Brouwer

Amsterdam UMC

t.f.brouwer@amsterdamumc.nl0205669111

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Feb 19, 2026