Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05232045 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Automated System for Monitoring Urine Output in Intensive Care Patients

StatusNot Yet Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 years 11 months later Jan 2026 → Jan 1, 2029
See other at-risk trials from Meir Medical Center

Record History

See every version on ClinicalTrials.gov ↗

  1. Notable Primary completion pushed from Jan 2026 to Jan 1, 2029
    • Start date: Dec 2025 to Dec 1, 2027
    • Study completion pushed from Jun 2026 to Jun 1, 2029
    • Eligibility criteria revised
  2. Notable Start date: Dec 2024 to Dec 2025v5
  3. Notable Primary completion date: Jan 2024 to Jan 2026
    • Start date: Dec 2023 to Dec 2024
    • Study completion date: Jun 2024 to Jun 2026
    v4
  4. Notable Start date: Jun 2023 to Dec 2023v3
  5. Notable Start date: Jun 2022 to Jun 2023v2
  6. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05232045
Lead Sponsor Meir Medical Center
Conditions
(from sponsor)
Acute Kidney Injury in the ICU
Enrollment 1,800 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov