Automated System for Monitoring Urine Output in Intensive Care Patients

Not yet recruiting

• Conditions: Acute Kidney Injury in the ICU
• Interventions: Drug: Automated urinary output collection system group (tight monitoring of urine output)

• Registration Number: NCT05232045
• Lead Sponsor: Meir Medical Center

Brief Summary

Acute kidney injury is common among ICU-admitted patients, and is associated with increased morbidity and mortality. Early recognition is essential to prevent complications. In this study we aim to examine whether strict monitoring of urine output may reduce the incidence of acute kidney injury, allow for less positive fluid balance and reduce the clinical symptoms of fluid overload in ICU patients. Currently we monitor urine output using a Urinometer, with manual recording. From June 2022 we will begin routine use of an automated urine monitoring system in the ICU and test its effect on the parameters listed above. We will conduct a before-after retrospective intervention. The group of patients in whom the automated system will be used, from June 2022 to January 2024, will be the study group. The patients admitted to the ICU in the period between January 2021 and June 2022 will be the control group. We will include patients aged 18-100, who were admitted to the General Intensive Care Unit in Meir Medical Center from January 2021 to January 2024, and had admission time longer than 48 hours. Patients without a urinary catheter will not be included. The study will be conducted in the format of observational data collection from hospital files and computerized systems (Metavision system and Chameleon system). We estimate that we will include about 900 patients in the study group and about 900 in the control group. All demographic and inpatient data will be statistically examined by a qualified statistician depending on the type of data.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-02-01
• Study First Submitted QC: 2022-02-01
• Study First Posted: 2022-02-09
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-13
• Last Update Posted: 2024-03-15
• Study Start: 2024-12
• Primary Completion: 2026-01
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1800

Inclusion Criteria

Patients aged 18-100, who were admitted to the General Intensive Care Unit in Meir Medical Center from January 2021 to January 2024, and had admission times longer than 48 hours.

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Exclusion Criteria

Patients without a urinary catheter, Patients with admission times less than 48 hours.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Automated urinary output collection system group (tight monitoring of urine output)	Automated urinary output collection system group (tight monitoring of urine output)	-

Primary Outcome Measures

Name	Time	Method
Prevalence of acute kidney injury	June 2023-January 2024	Primary outcome: To investigate whether the use of an automatic urinary output monitoring system in ICU patients will decrease the incidence of acute kidney injury

Trial Locations

Locations (1)

Meir Medical Center; 🇮🇱 Kfar Saba, Israel