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RecruitingPHASE2INTERVENTIONAL

Pulse Study: Peripheral Use of Low-dose Vasopressors for Safety and Efficacy in the Intensive Care Unit

This study, called the "Pulse Study," is looking at a new way to give medicines called vasopressors, which are used to increase blood pressure in very unwell patients in intensive care. Currently, these medicines are usually given through a large IV line placed in a major vein in the neck, arm, or groin, called a central line. While effective, central lines can sometimes lead to complications like infections or a collapsed lung. This research is exploring if it's safe and effective to give these blood pressure medicines through a smaller, standard IV line (like the ones you might get for fluids) in the arm or hand. This could allow doctors to start treatment quicker and avoid some of the risks associated with central lines. The study will first check if this new approach is practical and safe in a small group of patients, paving the way for larger studies in the future.

At a glance

Status
Recruiting
Phase
PHASE2
Sponsor
Kingston Health Sciences Centre
Enrolment target
50
Start
03 Feb 2025
Estimated completion
30 Jun 2026

What is this study about?

When people are very sick, particularly in intensive care, their blood pressure can drop dangerously low. To help with this, doctors often use special medicines called vasopressors, which work by making blood vessels narrower, thereby increasing blood pressure. Typically, these powerful medicines are given through a special tube called a central line. This tube is placed into a large vein, usually in the neck, chest, or groin, and requires a skilled doctor and often an ultrasound scanner to put it in safely. While central lines are very important, they do carry some risks, such as infection or damage to nearby organs like the lung.

There's a new idea emerging: could we give these blood pressure medicines through a regular, smaller IV line, like the ones you might have in your arm or hand? Historically, doctors have been hesitant to do this because of a concern that the medicine might leak out of the vein and damage the surrounding tissue. However, some newer evidence suggests this might be safer than previously thought, especially with lower doses.

The "Pulse Study" aims to investigate this new approach. It's a "Phase 2" study, meaning it's an early-stage trial focusing on whether this method is practical and safe for patients. The researchers want to see if giving vasopressors through a standard IV in the arm or hand is generally safe for patients in intensive care, and also if healthcare staff find it acceptable and easy to follow. The goal is to develop a clear set of guidelines for using this method. If this study shows promise, it could lead to bigger studies, and eventually, a new way to help critically ill patients potentially more quickly, and with fewer risks than current methods.

Key takeaways

  • This study explores a new way to give blood pressure medicines through a regular IV in the arm or hand.
  • The goal is to provide these vital medicines quicker and potentially avoid a central line, which has its own risks.
  • It's an early-stage study focusing on the safety and practicality of this new treatment method.
  • Critically ill patients in intensive care with low blood pressure are eligible.
  • Close monitoring will be a key part of ensuring safety throughout the study.

Who may be eligible?

To be able to take part in this study, you would need to be over 18 years old. You would also need to be in intensive care and require medicines to support your blood pressure, at certain minimum doses. Importantly, you shouldn't already have a central line (a large IV in your neck, chest, or groin) or a PICC line (another type of longer-term IV) in place.

There are also reasons why you might not be able to join. For example, if you need urgent kidney dialysis using a specific type of catheter, or if your blood pressure is so low that you already need more than two different blood pressure-raising medicines at a certain level when you first arrive in intensive care. You also cannot be pregnant or if there's a suspicion that you might be.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Am I 18 years old or older?
  2. Am I in intensive care and needing medicine to raise my blood pressure?
  3. Do I currently NOT have a central line or PICC line in place?
  4. Am I NOT pregnant or suspected to be pregnant?
  5. Do I NOT need urgent kidney dialysis requiring a special catheter?
  6. Am I NOT currently needing more than two specific blood pressure medicines when first admitted to ICU?
Answer every question to see your result.

What does participation involve?

If you are eligible and agree to take part in this study, you would receive your blood pressure-raising medicine through a standard IV line placed in a vein in your arm or hand, rather than a central line. The medical team would carefully monitor you to ensure the medicine is working effectively and that the IV site remains safe. This is a very practical study that fits into your existing care in the intensive care unit, so it wouldn't involve extra visits or entirely new procedures beyond what's already done in intensive care. The study aims to understand the safety and practicality of this specific way of giving medication during your stay. Your participation would last for the duration of your need for these medications in the intensive care unit.

Potential risks and benefits

Potential benefits of participating include potentially receiving blood pressure support more quickly and potentially avoiding the need for a central line, which carries its own set of risks like infection or a collapsed lung. The main potential risk being investigated is the possibility of the medicine leaking out of the smaller IV and causing irritation or damage to the surrounding tissue, which is why close monitoring is part of the study. You have the right to withdraw from the study at any time, for any reason, without affecting your medical care.

Locations (1)

  • Kingston Health Sciences Center
    Verified postcode
    Kingston, Canada· Recruiting

Common questions

What is a vasopressor?

A vasopressor is a medicine that helps to raise your blood pressure when it's dangerously low, often by narrowing your blood vessels.

What is the difference between a central line and a peripheral IV?

A central line is a large IV placed into a big vein, usually in your neck, chest, or groin, used for strong medicines or long-term treatment. A peripheral IV is a smaller, more common IV placed in a vein in your arm or hand.

Why is this study important?

This study could help doctors give blood pressure-raising medicines more quickly and potentially avoid the need for a central line, which can have complications, improving care for very sick patients.

Is it safe to give these medicines through a peripheral IV?

That's exactly what this study is trying to find out. While there have been concerns in the past, new information suggests it might be safer than previously thought, especially with careful monitoring.

What if I decide I don't want to be in the study anymore?

You can decide to stop participating at any time. Your decision will not affect the medical care you receive.

How to find out more

Dr. Boyd, PhD, MD

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Pulse Study: Peripheral Use of Low-dose Vasopressors for Saf…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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