CVCs Versus Midline Catheters
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAlbert Einstein College of Medicine
About this trial
The goal of this clinical trial is to learn if midline catheters can reduce adverse patient outcomes in adult patients requiring a single vasopressor. The main questions the study aims to answer are:
* Do midline catheters reduce the rates of catheter-related bloodstream infections as compared to central venous catheters? * Do midline catheters reduce the rates of deep venous thrombosis as compared to central venous catheters? Researchers will compare midline catheters to central venous catheters to see if there is a reduction in these events.
Participants will be randomized to the midline catheter group or the central venous catheter group. The catheters will be part of standard of care for vasopressor therapy. The participants will be followed for 30 days.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients over 18 years of age being treated in the Emergency Department at Jacobi Medical Center
Have an upper extremity (left or right arm) that can accept a midline catheter
Able to provide consent (patient or health care proxy)
Clinical team believes the patient will require inpatient admission at the time of needing intravenous access
Disqualifiers
Patients in cardiac arrest (prior to achieving ROSC)
Patients with infection or burns at both upper extremities
Patient expected to be discharged from the hospital within 24 hours
Prisoner
Trial design
Design model
Parallel
Treatments tested in this trial
Ultrasound Guided Central Venous Catheter
DevicePatients randomized to this arm will receive an ultrasound guided central venous catheter. The catheter is 20cm in length.
Ultrasound Guided Midline Catheter
DevicePatients randomized to this arm will receive an ultrasound guided midline catheter. The catheter is 8-10cm in length.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: central venous catheterActive comparator 1 intervention
Group B: Midline catheterActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Number of catheter related bloodstream infections (CRBSI) within 28 days of placement
The number of CRBSIs will be determined by clinical signs of infection (i.e., fever, chills, leukocytosis or hypotension) and at least one positive blood culture within 28 days of placement of catheter. The total number of CRBSIs will be recorded per study arm.
Time frame
Up to 28 days from placement of catheterSecondary outcomes
1
Number of catheter failures
Any mechanical failures (accidental withdrawal or dislodgement, breakage, occlusion) will be documented. The total number of mechanical failures will be recorded, 1 or more per patient, by study arm. The type of mechanical failures will not be itemized.
Time frame
Up to 28 days from catheter placement2
Total number of replacement catheters
The total number of replacement IV catheters required will be documented. This will be assessed based on each study arm (midline and central line).
Time frame
Up to 28 days3
Total number of upper extremity deep venous thrombosis events
This is defined as symptomatic or asymptomatic DVT, verified by ultrasound or computed tomography. The total number of upper extremity DVT events will be recorded by study arm.
Time frame
From catheter insertion up to hospital discharge, up to 28 days from catheter insertion.4
Number of catheter leakage events
Catheter leakage events is defined as leakage of blood or fluids from the puncture site. The total number of catheter leakage events will be recorded by study arm.
Time frame
Up to 28 days from catheter placementSponsors and contacts
Click on the lead sponsor to view all of their trials.
Albert Einstein College of Medicine
Lead sponsor
Jacobi Medical Center
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: