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CompletedNCT03636113AiDe-RNUpdated May 10, 2021

Automated urIne Flow Detection to Reduce Errors and Nursing Workload

An observational study in Acute Kidney Injury and Kidney Injury, sponsored by University of Pittsburgh. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-05-10.

Sponsored by University of Pittsburgh · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
33
Ages
18 Years and older
Sex
All
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Study summary

This study is an observational study which seeks to examine a) the accuracy of the Clarity Renal Monitoring System (Clarity RMS)® sensor kit at the bedside compared to manual urine output monitoring, b) total time/effort per patient with and without the device, c) the ease of use, clinical acceptance, and d) preliminary data on the detection of AKI using the Clarity RMS® sensor kit compared to standard care

Read the detailed description

The majority of physiological parameters of the patient in a critical care setting today are electronically monitored. Automation of these parameters not only reduces workload and human error, but also may provide alarms and warnings when these parameters fall below a pre-set range. Currently, urine output may be the most relevant physiological parameter that still involves manual recordings in the critical care setting.

In 2004, The Acute Dialysis Quality Initiative (ADQI), a group of experts in kidney dysfunction, proposed the RIFLE criteria for acute kidney injury (AKI). They describe Risk, Injury and Failure severity classes and Loss and End stage Kidney Disease outcome classes. The severity grades are based on serum creatinine, urinary output or both. More recently the Acute Kidney Injury Network (AKIN) stages for kidney injury added smaller relative increases in serum creatinine levels to classify patients at risk. Since the classification has been proposed, tens of thousands of patients have been involved in studies validating the RIFLE and AKIN criteria as a classification system for AKI. The 2012 Kidney Disease Improving Global Outcomes (KDIGO) AKI clinical practice guideline published in 2012 adopted modified RIFLE/AKIN criteria for classification of AKI. Studies using these criteria report kidney injury in Intensive Care Units at incidences of 50-70%.

Serum creatinine is considered a gold standard for measurement of kidney function; however, increases in its levels are seen only after there is approximately 50% loss of renal function, hindering early and sensitive detection of kidney injury and thus appropriate treatment. Many individual factors of the hospitalized patient can also interfere with the accuracy of changes in levels of serum creatinine, making this a less than ideal marker for kidney injury.

While urine output is an easily available biomarker of kidney function, only a small percentage of current studies that incorporate RIFLE and AKIN criteria utilize urinary output as a diagnostic criterion for AKI. Fluid overload has been shown to be a factor of increased mortality and further AKI. Sodium and water overload are common complications of fluid resuscitation, an initial treatment in many cases of AKI. Studies have shown that oliguria for three or more days, and a higher percentage of days with fluid overload after an initial AKI diagnosis is made, are two proven independent predictors for the development of sepsis post-AKI. In a recent study of periods of oliguria as a predictor of higher mortality in critically ill patients the authors note "treating urine flow as a continuous physiological variable instead of an interval parameter that is currently a challenge to measure accurately would provide more time points for the detection of AKI... in clinical practice, the hourly urine flow provides more precision for risk assessment and establishes early time for interventions." Current practice for measuring urine output in most hospitals worldwide involves manual recording on an hourly basis at best, and often one or two times per shift. It is essential to develop updated easy-to use- tools and systems for monitoring and managing patient fluid balance, for prevention and treatment of acute kidney injury and for patient survival. RenalSense has developed such a technology to enable online continuous monitoring of urine output and kidney function.

The current standard of care for urine output monitoring is the "manual" urometer. This approach is labor intensive, and prone to measurement error. An automated system would likely improve accuracy and reduce work load.

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Conditions studied

  • Acute Kidney Injury
  • Kidney Injury
03

In context

Acute Kidney Injury

1,595 studies on the registry are indexed under Acute Kidney Injury; 371 are open to participants now.

This study's enrollment of 33 is below the median of 150 across 773 observational studies indexed under Acute Kidney Injury.

Browse Acute Kidney Injury studies →

Lead sponsor

University of Pittsburgh is the lead sponsor of 1,385 studies on the registry; 167 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 4 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

ICU Nurses

Inclusion criteria

  • Male and Female ICU nurses
  • Caring for 1 or more patients in ICU with a Foley catheter in situ

Exclusion criteria

Exclusion Criteria:

  • Nurse managing a patient who will be in ICU less than 4 hours
  • Nurse managing a patient who is not producing urine
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
33 participants (actual)
Patient registry
No

Groups and cohorts

  • ICU nurses -manual

    Standard method of Urine Output monitoring

  • ICU nurses -automated

    Device- Clarity RMS Electronic sensor

    Device: Clarity RMS Electronic Sensor

Interventions

  • DeviceClarity RMS Electronic Sensor

    The urinary foley catheter with electronic sensor will be placed within the Operating Room prior to surgery. Upon arrival to the ICU, the device will be connected to an electronic console by study coordinator. The study coordinator will weigh the urine drainage bag and record the weight every hour for 4-6 hours. The device will record urine flow on a 15 minute interval up to 6 hours

06

What researchers measure

Primary outcomes

  1. Accuracy of the Clarity RMS® electronic sensor

    6-hour observation data, hourly urine output obtained from the EMR, and urine output monitoring captured by the Clarity RMS® electronic sensor

    Time frame: 6 hours after ICU admission

07

Study locations

1 site
  • UPMC Presbyterian Hosptial
    Pittsburgh, Pennsylvania 15213, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 10, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03636113
Lead sponsor
University of Pittsburgh
Collaborators
RenalSense Ltd
Responsible party
John Kellum (Professor & Vice Chair for Research, University of Pittsburgh) — Principal investigator
First posted
Aug 17, 2018
Start date
Jul 11, 2018
Primary completion
Dec 28, 2018
Completion
Jan 31, 2021
Last update
May 10, 2021

Study contacts

John Kellum, MD
principal investigator · University of Pittsburgh

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.

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