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NCT Number: NCT05232045

Automated System for Monitoring Urine Output in Intensive Care Patients

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.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Meir Medical Center

Kfar Saba, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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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Treatment and study plan

Automated urinary output collection system group (tight monitoring of urine output)

Drug

Automated urinary output collection system group (tight monitoring of urine output)

Primary outcomes

  1. Prevalence of acute kidney injury

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Sara Dichtwald, Dr

CONTACT

[email protected]

972-9-7472133 ext. 1

Sponsors and collaborators

Lead sponsor

Meir Medical Center

Other

Registry information

Official study title

Automated System for Monitoring Urine Output in Intensive Care Patients: What Are the Advantages? Before-after Intervention Study

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 9, 2022
Registry last updated
May 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.