Acute Kidney Injury in the ICUNCT05232045
Automated System for Monitoring Urine Output in Intensive Care Patients
An observational study of Acute Kidney Injury in the ICU, run by Meir Medical Center at 1 site in Israel.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Acute Kidney Injury in the ICU
- What is being tested?
- Automated urinary output collection system group (tight monitoring of urine output)
- How many people
- 1,800 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Dec 2027to 1 Jun 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged 18-100, who were admitted to the General Intensive Care Unit in Meir Medical Center from January 2021 to January 2024
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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Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Automated System for Monitoring Urine Output in Intensive Care Patients: What Are the Advantages? Before-after Intervention Study
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.
- Conditions
- Acute Kidney Injury in the ICU
- Being tested
- Automated urinary output collection system group (tight monitoring of urine output)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automated urinary output collection system group (tight monitoring of urine output)Drug
Automated urinary output collection system group (tight monitoring of urine output)
| Study group | Role | What they receive |
|---|---|---|
| Automated urinary output collection system group (tight monitoring of urine output) | Not described Receives: Drug: Automated urinary output collection system group (tight monitoring of urine output) | |
| Manual urinary output collection system group (routine monitoring of urine output) | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of acute kidney injury
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
Measured: June 2023-January 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2022
- Study start1 Dec 2027 (estimated)
- Primary completion1 Jan 2029 (estimated)
- Study completion1 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney Injury in the ICUStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 1,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, sara dichtwald, Meir Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05232045
- Sponsor's protocol ID
- 0033-22-MMC
- Status last verified
- Oct 2026
- First submitted
- 1 Feb 2022
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automated System for Monitoring Urine Output in Intensive Care Patients: What Are the Advantages? Before-after Intervention Study
- ClinicalTrials.gov ID
- NCT05232045
- Acronym / sponsor ID
- 0033-22-MMC
- Conditions
- Acute Kidney Injury in the ICU
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,800 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- 1 Dec 2027 (estimated)
- Primary completion
- 1 Jan 2029 (estimated)
- Study completion
- 1 Jun 2029 (estimated)
- First posted
- 9 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Automated urinary output collection system group (tight monitoring of urine output) | – | Drug: Automated urinary output collection system group (tight monitoring of urine output) |
| Manual urinary output collection system group (routine monitoring of urine output) | – | – |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 18-100, who were admitted to the General Intensive Care Unit in Meir Medical Center from January 2021 to January 2024
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Automated urinary output collection system group (tight monitoring of urine output)Automated urinary output collection system group (tight monitoring of urine output) | Drug | Automated urinary output collection system group (tight monitoring of urine output) |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury in the ICU, run by Meir Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sara Dichtwald, Dr (972-9-7472133 ext. 1, sara.dichtwald@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of acute kidney injury (time frame: June 2023-January 2024). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.