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Novel Strategy to Encourage Early Removal of Central Venous Catheters

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04136561
Recruitment Status : Withdrawn (No participants enrolled. Unable to enroll)
First Posted : October 23, 2019
Last Update Posted : September 9, 2020
Sponsor:
Information provided by (Responsible Party):
Amit Bahl, William Beaumont Hospitals

Brief Summary:
The goal of this study is to determine if early placement of a midline catheter in patients with a central venous catheter (CVC) will decrease the number of days the CVC is in place. Patients who are in the medical intensive care unit (MICU) and have a CVC may be approached to join the study. Those who meet study eligibility and provide written consent will be enrolled. The longer the CVC remains in place,the greater the chance of developing an infection or blood clot. Any IV line that is placed (CVC, midline, peripheral line) comes with the risk of infection or blood clots, although that risk is generally less with the midline and peripheral IV lines than a CVC. The treating team will make the decision when to remove the CVC. The timeline of removal will be compared to previous data collected on patients similar to the ones in this study. During their hospital stay, study patients will be monitored for how well the midline catheter is functioning as well as if they develop a catheter related blood clot or infection.

Condition or disease Intervention/treatment Phase
Vascular Access Complication Central Line Complication Central Line-Associated Infection Superficial Vein Thrombosis Deep Vein Thrombosis Device: Midline catheter Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Prospective with historical case matched controls, Non-randomized, Single site
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Novel Strategy to Encourage Early Removal of Central Venous Catheters
Estimated Study Start Date : September 2020
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : December 2021

Arm Intervention/treatment
Experimental: CVC and Midline Catheter
Existing standard of care CVC. Midline catheter placed within 24 hours of CVC placement.
Device: Midline catheter
Midline catheter placed in patients with existing standard of care CVC

No Intervention: CVC
Standard of care CVC: case-matched controls using baseline data.



Primary Outcome Measures :
  1. CVC hours [ Time Frame: at CVC removal, at any time up to 30 days ]
    Number of hours from CVC insertion to CVC removal


Secondary Outcome Measures :
  1. CLABSI [ Time Frame: 30 days ]
    Number of participants with catheter-related lab-confirmed blood stream infection per Center of Disease Control (CDC) guidelines

  2. Upper extremity venous thrombosis [ Time Frame: 30 days ]
    Number of participants with proven sonographic diagnosis of upper extremity deep vein thrombosis or superficial vein thrombosis

  3. Midline IV catheter survival [ Time Frame: 30 days ]
    Number of participants with midline catheter survival, defined as ability to withdraw 3-5 mls blood or flush without resistance with 5 ml saline daily, until completion of therapy

  4. Midline Catheter Associated Phlebitis [ Time Frame: 30 days ]
    Number of participants with each grade of phlebitis as assessed 0-5 Visual Phlebitis scale, where 0 indicates no phlebitis and 5 indicates advanced stages of thrombophlebitis



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients 18 years of age or older admitted to the MICU at Beaumont Hospital- Royal Oak who require a CVC Midline placement by the vascular access team within 24 hours of CVC placement

Exclusion Criteria:

  • Patients not admitted to MICU
  • Patients < 18 years of age
  • Patients identified to require a PICC for extended duration of therapy
  • Patients with midline catheters, pre-existing ports, dialysis catheters (Quinton), or other vascular access already inserted within the first 24 hours of CVC insertion (peripheral IV catheters are allowed)

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): NCT04136561


Locations
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United States, Michigan
Beaumont Hospital - Royal Oak
Royal Oak, Michigan, United States, 48073
Sponsors and Collaborators
William Beaumont Hospitals
Investigators
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Principal Investigator: Amit Bahl, MD William Beaumont Hospitals
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Responsible Party: Amit Bahl, Director Emergency Medicine Ultrasound, William Beaumont Hospitals
ClinicalTrials.gov Identifier: NCT04136561    
Other Study ID Numbers: 2019-235
First Posted: October 23, 2019    Key Record Dates
Last Update Posted: September 9, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Amit Bahl, William Beaumont Hospitals:
intravenous access
vascular access
IV survival
IV catheter complication
Central venous access
Central Line-associated Bloodstream Infection (CLABSI)
Additional relevant MeSH terms:
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Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases