Midline vs Central Venous Catheters for Reducing Complications

Not yet recruiting at 1 trial location

Overseen By Sandeep Dhillon, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Albert Einstein College of Medicine

Must be taking: Vasopressors

Disqualifiers: Cardiac arrest, Pregnancy, Bacteremia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Up to 28 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether midline catheters, used for delivering medications, can reduce complications such as infections and blood clots compared to central venous catheters. The research focuses on adult patients at Jacobi Medical Center who need a single vasopressor (a drug to raise blood pressure). Participants will be randomly assigned to receive either an ultrasound-guided midline catheter or an ultrasound-guided central venous catheter while undergoing standard vasopressor therapy. Ideal candidates have a suitable arm for the catheter and are expected to remain in the hospital for at least one day. As an unphased trial, this study allows patients to contribute to important research that could enhance future medical care.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. It focuses on the use of catheters for patients requiring a vasopressor.

What prior data suggests that these catheter techniques are safe for reducing complications?

Research has shown that using ultrasound to guide central venous catheters (CVCs) carries some risks. Problems occur in 8% to 15% of cases, including a collapsed lung, bleeding, and incorrect catheter placement. However, ultrasound guidance can enhance safety and reduce these risks.

For midline catheters, research indicates they generally present fewer problems than other types. They reduce the chance of catheter failure by 85% compared to longer peripheral catheters. Nonetheless, issues such as infections, blood clots, and leaks can still arise.

Both types of catheters have their advantages and disadvantages. These factors are important to consider when deciding to join a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it could reveal new insights into reducing complications from catheter use. Unlike traditional methods, this trial compares two specific techniques: the ultrasound-guided central venous catheter and the ultrasound-guided midline catheter. The central venous catheter is often used for long-term access but can have higher risks of complications. In contrast, the midline catheter is less invasive and may offer a safer option for patients needing extended intravenous access. By evaluating these techniques side by side, the trial aims to determine which method minimizes risks and improves patient outcomes.

What evidence suggests that midline catheters are effective for reducing complications?

This trial will compare ultrasound-guided central venous catheters (CVCs) with ultrasound-guided midline catheters to evaluate their effectiveness in reducing complications. Research has shown that using ultrasound to guide CVC placement can reduce complications like infections and accidental punctures. Typically, about 3% of CVC placements result in major complications, but ultrasound guidance can lower these risks.

Participants in this trial may receive a midline catheter, which research suggests may have fewer complications than CVCs. Midline catheters are associated with lower rates of blockages and bloodstream infections and show an 85% reduction in the risk of failure compared to longer peripheral catheters. Overall, midline catheters might offer a safer option with fewer complications. ^{3 6 7 8 9}

Who Is on the Research Team?

Sandeep Dhillon, MD

Principal Investigator

Jacobi Medical Center, Albert Einstein College of Medicine

Are You a Good Fit for This Trial?

This trial is for adult patients who need a single vasopressor and will be receiving either a midline catheter or central venous catheter. Specific eligibility criteria are not provided, but typically participants must meet certain health conditions to ensure safety.

Inclusion Criteria

Able to provide consent (patient or health care proxy)

I need a long-term IV line for my treatment.

My arm can have a midline catheter inserted.

Exclusion Criteria

Patient expected to be discharged from the hospital within 24 hours

Prisoner

Pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Treatment

Participants receive either a midline catheter or a central venous catheter as part of standard care for vasopressor therapy

Up to 28 days

Inpatient care

Follow-up

Participants are monitored for catheter-related complications such as bloodstream infections, thrombosis, and mechanical failures

30 days

Regular monitoring during hospital stay

What Are the Treatments Tested in This Trial?

Interventions

• Ultrasound Guided Central Venous Catheter
• Ultrasound Guided Midline Catheter

Trial Overview The study compares the use of ultrasound-guided midline catheters with ultrasound-guided central venous catheters in adults requiring vasopressors. It aims to see if midline catheters can lower infection rates and deep vein thrombosis compared to central lines.

How Is the Trial Designed?

Group I: central venous catheter Active Control 1 Intervention

If randomized to this group, patients will receive a triple lumen central venous catheter

Group II: Midline catheter Active Control 1 Intervention

If randomized to this group, patients will receive a single lumen midline catheter

Who Is Running the Clinical Trial?

Albert Einstein College of Medicine

Lead Sponsor

Trials

302

Recruited

11,690,000+

Jacobi Medical Center

Collaborator

Trials

24

Recruited

4,500+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11489976/

Systematic review of ultrasound-guided central venous ... These results suggested that ultrasound-guided CVC placement was beneficial in reducing inadvertent arterial puncture and catheter kinking, ...

2. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/fullarticle/2815818

Complication Rates of Central Venous Catheters This study found that approximately 3% of CVC placements were associated with major complications, with ultrasonography guidance reducing some of the specific ...

3. annalsofintensivecare.springeropen.com annalsofintensivecare.springeropen.com/articles/10.1186/s13613-023-01141-w

How to improve the efficiency and the safety of real-time ... This narrative review aims to synthesize current knowledge on evidence-based best practices for CVC that improve the use and feasibility of real-time ...

4. ccforum.biomedcentral.com ccforum.biomedcentral.com/articles/10.1186/s13054-024-05162-0

Central venous catheter-related infections: a systematic ... US-guided CVC placement significantly reduces the risk of catheter-related infections compared to the AL technique, particularly when performed by experienced ...

5. nejm.org nejm.org/doi/full/10.1056/NEJMoa1500964

Intravascular Complications of Central Venous ... The primary outcome was the incidence of major catheter-related complications from the time of catheter insertion to 48 hours after catheter ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36331108/

Safety and outcome of ultrasound-guided tunneled central ... First-attempt success rate was 74%. Surgical complications were seen in four of 61 (7%). Nonsurgical complications were seen in 33/61 (54%) ...

7. ccforum.biomedcentral.com ccforum.biomedcentral.com/articles/10.1186/s13054-017-1814-y

Ultrasound-guided central venous catheter placement The use of ultrasound (US) has been proposed to reduce the number of complications and to increase the safety and quality of central venous catheter (CVC) ...

8. nejm.org nejm.org/doi/full/10.1056/NEJMra011883

Preventing Complications of Central Venous Catheterization Arterial puncture, hematoma, and pneumothorax are the most common mechanical complications during the insertion of central venous catheters (Table 2). Overall, ...

9. bjanaesthesia.org bjanaesthesia.org/article/S0007-0912(22)00509-8/fulltext

Mechanical complications after central venous ... The primary outcome measures were the following mechanical complications: bleeding, cardiac arrhythmia, arterial puncture, arterial ...