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

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ClinicalTrials.gov Identifier: NCT03933722
Recruitment Status : Recruiting
First Posted : May 1, 2019
Last Update Posted : May 1, 2019
Sponsor:
Information provided by (Responsible Party):
The Cooper Health System

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

Condition or disease Intervention/treatment
Blood Pressure Device: Caretaker

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).

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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 4, 2019
Estimated Primary Completion Date : February 4, 2020
Estimated Study Completion Date : February 4, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Group/Cohort 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.




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.



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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03933722


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

Locations
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United States, New Jersey
Cooper University Hospital Recruiting
Camden, New Jersey, United States, 08031
Contact: Irwin Gratz, MD    856-342-2000    gratz-irwin@cooperhealth.edu   
Sponsors and Collaborators
The Cooper Health System
Investigators
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Principal Investigator: Irwin Gratz, MD The Cooper Health System

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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Additional relevant MeSH terms:
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Shock, Septic
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Shock