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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/19/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/19/2021.

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