Comparison of a Non-Invasive Central Venous Pressure Device and Physical Examination in Patients With Chronic Kidney Disease

NCT01243515 | Withdrawn

• 1 other identifier: MLS STP-9000006
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to determine whether a correlation exists between the Mespere Non-Invasive Central Venous Pressure (NICVP) device for measuring central venous pressure (CVP), and assessment of CVP via physical examination.

Conditions

Central Venous Pressure

Keywords

Central Venous Pressure; Kidney Diseases; Chronic Kidney Disease; Healthy Subjects; Non-Invasive Monitor

Outcome Measures

Primary Outcomes (1)

• Central Venous Pressure (CVP)

  To determine if the CVP from the non-invasive monitor correlates with the CVP from physical examination

  0-3 hours

Study Arms (2)

Chronic Kidney Disease

minimum 7 subjects (male and female)

Device: Non-Invasive Central Venous Pressure monitor; Procedure: Physical examination of jugular vein

Healthy subjects

minimum 3 subjects (male and female)

Device: Non-Invasive Central Venous Pressure monitor; Procedure: Physical examination of jugular vein

Interventions

Non-Invasive Central Venous Pressure monitor DEVICE

An adhesive patch (connected to the Mespere NICVP monitor) is placed on the neck of the subject, to determine if the CVP values displayed by the device correlates with CVP values obtained by physical examination (standard clinical practice)

Also known as: NICVP monitor

Chronic Kidney Disease; Healthy subjects

Physical examination of jugular vein PROCEDURE

Physicians assess CVP using the jugular vein of the subject

Chronic Kidney Disease; Healthy subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with Chronic Kidney Disease (CKD)

You may qualify if:

• Age 18 years or older at the time of enrolment
• Chronic Kidney Disease patients and healthy volunteers
• Participants should be able to provide written informed consent
• Subject is termed eligible as determined by Pre-Screening Phase (as defined in protocol)

You may not qualify if:

• Unable to identify external jugular vein (EJV)
• Unable to identify internal jugular vein (IJV)
• Unable to access right side of subject's neck
• Allergic to adhesive tape
• History of central vein stenosis
• Undergoing photodynamic therapy (PDT)
• Presence of an arteriovenous fistula

Sponsors & Collaborators

• Mespere Lifesciences Inc.: lead
• St. Joseph's Healthcare Hamilton: collaborator

Study Sites (1)

St. Joseph's Hamilton Healthcare

Hamilton, Ontario, L8N 4A6, Canada

Location

MeSH Terms

Conditions

Kidney Diseases; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Renal Insufficiency; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Azim S Gangji, MD

  St. Joseph's Healthcare Hamilton

  PRINCIPAL INVESTIGATOR

• Melissa T Perri, MESc

  Mespere Lifesciences Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2010
• First Posted: November 18, 2010
• Last Updated: February 8, 2013

Record last verified: 2013-02

Locations

CA (1)