Automated System for Monitoring Urine Output in Intensive Care Patients

Sponsor
Meir Medical Center (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05232045
Collaborator
(none)
1,800
1
24
74.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Automated urinary output collection system group (tight monitoring of urine output)

Study Design

Study Type:
Observational
Anticipated Enrollment :
1800 participants
Observational Model:
Case-Control
Time Perspective:
Retrospective
Official Title:
Automated System for Monitoring Urine Output in Intensive Care Patients: What Are the Advantages? Before-after Intervention Study
Anticipated Study Start Date :
Jun 1, 2022
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Jun 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Automated urinary output collection system group (tight monitoring of urine output)

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

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

Outcome Measures

Primary Outcome Measures

  1. Prevalence of acute kidney injury [June 2022-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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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.

-

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

-

Contacts and Locations

Locations

Site City State Country Postal Code
1 Meir Medical Center Kfar Saba Israel

Sponsors and Collaborators

  • Meir Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
sara dichtwald, Dr, Meir Medical Center
ClinicalTrials.gov Identifier:
NCT05232045
Other Study ID Numbers:
  • 0033-22-MMC
First Posted:
Feb 9, 2022
Last Update Posted:
Feb 9, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 9, 2022