Peripheral Vasopressors for Intensive Care Unit Patients
(PULSE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new method of administering vasopressors to ICU patients with low blood pressure. Typically, these medications are delivered through a large tube in a major vein. This study will evaluate the safety and effectiveness of using a smaller tube, called a Peripheral Venous Catheter, in an arm or hand vein. The trial will compare the two methods to determine if the smaller tube can reduce risks such as lung collapse or bleeding. Adults in shock who require specific doses of blood pressure medication and do not already have certain tubes in place may qualify for this study. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to significant medical advancements.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that administering vasopressors (medications to raise blood pressure) through a small tube in the arm or hand can be safe. One study found this method effective for patients with certain heart conditions. Although there is a risk of medication leaking into nearby tissue, recent findings suggest this can be managed. Another study demonstrated that using these medications in early sepsis care is effective, with a focus on safety and patient outcomes. These studies provide promising evidence that using vasopressors in this manner might be a safe alternative, particularly to avoid complications from using a larger tube in a major vein.12345
Why are researchers excited about this trial?
Researchers are excited about using peripheral venous catheters for administering vasopressors in ICU patients because this approach could offer a less invasive alternative to the standard central venous catheter. Central venous catheters, while effective, come with higher risks of complications like infections and require more expertise to place. Using peripheral venous catheters might minimize these risks and make the treatment more accessible and faster to administer, especially in urgent situations. This shift could improve patient safety and streamline care in the intensive care setting.
What evidence suggests that this trial's treatments could be effective for increasing blood pressure in ICU patients?
Research has shown that using small tubes called peripheral venous catheters (PVCs) to administer medications that raise blood pressure is often safe and effective. These medications help patients in shock. In this trial, one group of patients will receive vasopressors through PVCs, which can avoid problems linked to central venous catheters (CVCs), such as serious infections or lung issues. Evidence suggests that patients using PVCs experience similar outcomes to those using CVCs but with fewer risks. This method can also speed up treatment because PVCs are easier to insert. Overall, early data supports PVCs as a good option for administering these medications.25678
Who Is on the Research Team?
Gord Dr., PhD, MD
Principal Investigator
Queen's University, Kingston Health Sciences Center
Are You a Good Fit for This Trial?
This trial is for ICU patients who need blood pressure support due to shock and are undergoing procedures like central line insertion. It's not suitable for those with conditions that prevent safe participation or where peripheral vasopressor use is contraindicated.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Feasibility Study
Implementation of a peripheral vasopressor protocol and assessment of recruitment feasibility, data capture rate, and acceptability rate by healthcare providers
Safety Assessment
Assessment of safety of peripheral vasopressor administration, capturing adverse events such as extravasation, pneumothorax, and deep vein thrombosis
Follow-up
Participants are monitored for clinically relevant outcomes such as alive and central line-free days, infection rates, and mortality
What Are the Treatments Tested in This Trial?
Interventions
- Peripheral Venous Catheter
Find a Clinic Near You
Who Is Running the Clinical Trial?
Kingston Health Sciences Centre
Lead Sponsor
Kingston Health Sciences Centre
Lead Sponsor