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Automated System for Monitoring Urine Output in Intensive Care Patients

NCT ID: NCT05232045

Last Updated: 2025-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

1800 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-12-31

Study Completion Date

2026-06-30

Brief Summary

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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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Detailed Description

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Conditions

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Acute Kidney Injury in the ICU

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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

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

Intervention Type DRUG

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

Manual urinary output collection system group (routine monitoring of urine output)

No interventions assigned to this group

Interventions

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

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

\-

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Meir Medical Center

OTHER

Sponsor Role lead

Responsible Party

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sara dichtwald

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Meir Medical Center

Kfar Saba, , Israel

Site Status

Countries

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Israel

Central Contacts

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Sara Dichtwald, Dr

Role: CONTACT

[email protected]
972-9-7472133 ext. 1

Other Identifiers

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0033-22-MMC

Identifier Type: -

Identifier Source: org_study_id

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