Jacobi Medical Center
The Bronx, New York, 10461, United States
Location contact
Ariella Gartenberg, MD
CONTACT
Sandeep Dhillon, MD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT06884176
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
The Bronx, New York, 10461, United States
Ariella Gartenberg, MD
CONTACT
Sandeep Dhillon, MD
PRINCIPAL_INVESTIGATOR
Within the United States, around 5 million central venous catheters (CVCs) and 150 million peripheral catheters are inserted annually. A 2015 surveillance survey across 10 U.S. states revealed that 4% of hospitalized patients had 1 or more healthcare-associated infections, with 25.6% reported as device-associated infections. Device-associated infections included catheter-related bloodstream infection (CRBSI), catheter-associated urinary tract infections, and ventilator-associated pneumonia. In addition to increased rates of CRBSI, CVCs are associated with upper extremity deep venous thrombosis (DVT). Peripherally inserted central catheters (PICCs) have previously been proposed as an alternative to CVCs to avoid these complications. However, due to the increasing lumen diameter of PICCs, increased rates of catheter-related thrombosis as compared to CVCs have been reported. In contrast to PICCs where the catheter tip ends at the cavo-atrial junction near the right atrium, midline catheters are peripheral vascular devices inserted into the upper extremity veins that terminate at or below the axillary vein. As midlines terminate prior to the large vasculature of the chest, studies have demonstrated lower rates of CRBSI or DVTs as compared to the reported incidence of such complications with PICCs or CVCs. To date, there have been no large-scale randomized control trials comparing CVC and midline complication rates, including thrombosis, CRBSI, central-line associated readmission, and overall patient mortality.
The authors plan to conduct a parallel, 2-group, open-label randomized control trial at a single urban academic center. A convenience sample of adult patients will be obtained over the course of 1 year. Patients with single vasopressor requirements will be subject to enrollment. Patients will be enrolled in the study by clinicians participating in their care who are involved in the placement of the catheter (midline or CVC). Informed consent will take place in the emergency department (ED) prior to the catheter placement. Clinicians will ask patients who are being treated whether they are interested in the study. Study team members will then approach interested patients to obtain consent for the research.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients randomized to this arm will receive an ultrasound guided central venous catheter. The catheter is 20cm in length.
Patients randomized to this arm will receive an ultrasound guided midline catheter. The catheter is 8-10cm in length.
Time frame: Up to 28 days from placement of catheter
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 catheter placement
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
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: From catheter insertion up to hospital discharge, up to 28 days from catheter insertion.
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: Up to 28 days from catheter placement
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 insertion
Catheter infiltration events is defined as infiltration/swelling or pain around the insertion site with medication or fluid administration. The total number of catheter infiltration events will be recorded by study arm
Contact information is provided by the study sponsor or research team.
Ariella S Gartenberg, MD
CONTACT
Sandeep Dhillon, MD
CONTACT
Albert Einstein College of Medicine
Other
Complication Rates Associated With Central Venous Catheters Versus Midline Catheters: A Randomized Control Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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