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Caretaker vs. Blood Pressure Monitoring With Invasive Arterial Pressure Monitoring in Patients With Septic Shock

  • Clinicaltrials.gov identifier

    NCT03933722

  • Recruitment Status

    Recruiting

  • First Posted

    May 1, 2019

  • Last update posted

    May 1, 2019

Study Description

Brief summary:

Caretaker vs. Blood Pressure Monitoring With Invasive Arterial Pressure Monitoring in Patients With Septic Shock

  • Condition or Disease:Blood Pressure
  • Intervention/Treatment: Device: Caretaker
  • Phase: N/A

Detailed Description

The aim of this study is to compare blood pressure obtained using routine blood pressure sphygmomanometer, in patients with invasive arterial pressure monitoring that have septic shock, to a non-invasive device that continuously monitors central blood pressure (CareTaker).

Study Design

  • Study Type: Observational
  • Estimated Enrollment: 40 participants
  • Observational Model: Case-Only
  • Time Perspective: Prospective
  • Official Title: Comparison of Noninvasive Blood Pressure Monitoring With Invasive Arterial Pressure Monitoring in Patients With Septic Shock
  • Actual Study Start Date: February 2019
  • Estimated Primary Completion Date: February 2020
  • Estimated Study Completion Date: February 2021

Groups and Cohorts

Groups/Cohorts Intervention/treatment
: Caretaker
Comparing blood pressure obtained using routine blood pressure sphygmomanometer to a non-invasive device that continuously monitors central blood pressure (CareTaker).
Device: Caretaker
Application of Caretaker device to subjects that have septic shock and that have an invasive arterial pressure monitor placed.

Outcome Measures

  • Primary Outcome Measures: 1. Comparing blood pressure measurements by the Caretaker device to blood pressure measurements made with an intra-arterial pressure catheter. [ Time Frame: 20 minutes ]
    The primary outcome measure will be the average difference in systolic and diastolic blood pressure measurements between the investigational device (Caretaker) and the reference (intra-arterial catheter pressure) in subjects that have septic shock. In line with blood pressure validation guidelines, we will obtain multiple investigational-reference measurement pairs in each subject (20 minutes total) and will average the difference over all pairs from all subjects.
  • Secondary Outcome Measures: 1. Comparing blood pressure measurements by the Caretaker device to blood pressure measurements made with an upper arm cuff. [ Time Frame: 20 minutes ]
    Secondary outcome measure will be the average difference in systolic and diastolic blood pressure measurements between the investigational device (Caretaker) and a brachial cuff in subjects that have septic shock. In line with blood pressure validation guidelines, we will obtain multiple investigational-reference measurement pairs in each subject (4 pairs over 20 minutes) and will average the difference over all pairs from all subjects.

Eligibility Criteria

  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
  • Sampling Method: Non-Probability Sample
  • Study Population: Adults ages > 18 who have septic shock and have an arterial line monitor in place.

Criteria

Inclusion Criteria:

- Admitted with septic shock, with or without vasopressor support needed.

- Greater than or equal to 18 years of age.

- Have an arterial catheter already in place.

Exclusion Criteria:

- No arterial catheter in place.

- Contraindication to the application of the Caretaker device due to pre-existing finger
injury.

- Patients in whom use of a BP cuff is contraindicated.

Contacts and Locations

Contacts

Contact: Irwin Gratz, MD 856-342-2000 gratz-irwin@cooperhealth.edu

Locations

United States, New Jersey
Cooper University Hospital
Camden

Sponsors and Collaborators

The Cooper Health System

Investigators

Principal Investigator: Irwin Gratz, MD The Cooper Health System

More Information

  • Responsible Party: The Cooper Health System
  • ClinicalTrials.gov Identifier: NCT03933722 History of Changes
  • Other Study ID Numbers: 18-180EX
  • First Posted: May 1, 2019 Key Record Dates
  • Last Update Posted: May 1, 2019
  • Last Verified: April 2019
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: Yes
  • Additional relevant MeSH terms: Shock, Septic