Automatic Urine Output Measuring Device Performance Validation and Efficacy.

NCT03952689 | Unknown

• 1 other identifier: SHEBA-19-5839-ER-CTIL
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the efficacy of Serenno Medical Automatic Urine Output measuring device in patients with indwelling urinary catheter hospitalized in the cardiac surgery intensive care unit.

Conditions

Urine Output Decreased

Outcome Measures

Primary Outcomes (1)

• Urine volume measurement.

  Automatic device urine output measurement in compare with Urinometer

  24 hours

Secondary Outcomes (1)

• Acute renal failure detection by urine output measurement and creatinine level in the blood.

  24 hours

Study Arms (1)

Post cardiac surgery patients

EXPERIMENTAL

For all patients, readings of the urine output from both the Serenno system and the collection bag (urinometer) (by camera) will be recorder every 10 minutes, for the duration of 24 hours.

Device: Serenno Medical Automatic Urine Output measuring device

Interventions

Serenno Medical Automatic Urine Output measuring device DEVICE

Device that measures ongoing urine output will be connecter to the patients catheter. The urine count of the device will be compared to the "gold standard" measurement technique (nurse count).

Post cardiac surgery patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects, aged \>18 years
• Patients hospitalized in the intensive care unit requiring an indwelling urinary catheter for urine output monitoring for at least 24 hours.

You may not qualify if:

• Known urological pathology including but not limited to nephrolithiasis, polycystic kidney disease, congenital abnormalities of the kidneys and or urinary tract, history of obstructive uropathy, advanced chronic kidney disease (stage 4) of any cause.
• Known pregnancy or lactating women.
• Cognitive and/or psychiatric impairment which may not allow cognitive signing on the informed consent unless patient has a legal representative that was appointed prior to patient enrollment.

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Sheba medical center

Ramat Gan, 00000, Israel

Location

MeSH Terms

Conditions

Oliguria

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Eilon Ram, Dr

  Sheba Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Prospective Observational, single arm test, self-controlled.

Study Record Dates

• First Submitted: May 15, 2019
• First Posted: May 16, 2019
• Study Start: May 14, 2019
• Primary Completion: October 14, 2021
• Study Completion: October 14, 2021
• Last Updated: October 22, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)