Central Venous Catheter, Complication of Catheter, Midline Catheter
Conditions
Keywords
midline catheter, central venous catheter, central line related bloodstream infection
Brief summary
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.
Detailed description
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.
Interventions
DEVICEUltrasound Guided Central Venous Catheter
Patients randomized to this arm will receive an ultrasound guided central venous catheter. The catheter is 20cm in length.
DEVICEUltrasound Guided Midline Catheter
Patients randomized to this arm will receive an ultrasound guided midline catheter. The catheter is 8-10cm in length.
Sponsors
Albert Einstein College of Medicine
Jacobi Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
randomized to one of two therapies, central venous access or midline
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 * Requires a central line or midline catheter as an expected requirement of care * Patients requiring a single vasopressor due to hypotension
Exclusion criteria
* 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 * Pregnancy * Children less than 18 years of age * The patient is known or is suspected to be allergic to materials contained in the device * Patients known to have bacteremia * Patients with existing central venous catheter * Patients without the ability to consent (or no health care proxy to consent)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of catheter related bloodstream infections (CRBSI) within 28 days of placement | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of catheter failures | 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. |
| Total number of replacement catheters | 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). |
| Total number of upper extremity deep venous thrombosis events | 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. |
| Number of catheter leakage events | 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. |
| Number of catheter infiltration events | 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 |
Contacts
PRINCIPAL_INVESTIGATORSandeep Dhillon, MD
Jacobi Medical Center, Albert Einstein College of Medicine
Outcome results
None listed