Novel Strategy to Encourage Early Removal of Central Venous Catheters

NCT04136561 | Withdrawn FDA Device

• 1 other identifier: 2019-235
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Vascular Access Complication; Central Line Complication; Central Line-Associated Infection; Superficial Vein Thrombosis; Deep Vein Thrombosis

Keywords

intravenous access; vascular access; IV survival; IV catheter complication; Central venous access; Central Line-associated Bloodstream Infection (CLABSI)

Outcome Measures

Primary Outcomes (1)

• CVC hours

  Number of hours from CVC insertion to CVC removal

  at CVC removal, at any time up to 30 days

Secondary Outcomes (4)

• CLABSI

  30 days

• Upper extremity venous thrombosis

  30 days

• Midline IV catheter survival

  30 days

• Midline Catheter Associated Phlebitis

  30 days

Study Arms (2)

CVC and Midline Catheter

EXPERIMENTAL

Existing standard of care CVC. Midline catheter placed within 24 hours of CVC placement.

Device: Midline catheter

CVC

NO INTERVENTION

Standard of care CVC: case-matched controls using baseline data.

Interventions

Midline catheter DEVICE

Midline catheter placed in patients with existing standard of care CVC

CVC and Midline Catheter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Corewell Health East: lead

Study Sites (1)

Beaumont Hospital - Royal Oak

Royal Oak, Michigan, 48073, United States

Location

MeSH Terms

Conditions

Venous Thrombosis

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Amit Bahl, MD

  Corewell Health East

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Emergency Medicine Ultrasound

Model Details: Prospective with historical case matched controls, Non-randomized, Single site

Study Record Dates

• First Submitted: October 16, 2019
• First Posted: October 23, 2019
• Study Start: September 1, 2020
• Primary Completion: June 1, 2021
• Study Completion: December 1, 2021
• Last Updated: September 9, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)