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Not yet recruitingPHASE3INTERVENTIONAL

Venous Excess Ultrasound for Personalized Resuscitation in Septic Shock

This study is exploring a new way to guide fluid treatment for people with septic shock, a life-threatening infection where blood pressure drops dangerously low. While fluids are vital, too much can harm the kidneys. Researchers are using a special ultrasound technique called Venous Excess Ultrasound (VEXUS) to help doctors decide how much fluid to give. The main goal is to see if this VEXUS-guided approach is practical and helpful for patients. They want to check if it can prevent organs, particularly the kidneys, from being damaged by too much fluid, reducing the need for treatments like dialysis. This initial study helps decide if a larger trial should be done.

At a glance

Status
Not yet recruiting
Phase
PHASE3
Sponsor
Western University, Canada
Enrolment target
80
Start
01 Dec 2024
Estimated completion
28 Dec 2027

What is this study about?

This study is about a very serious condition called septic shock. This happens when an infection spreads throughout the body and causes blood pressure to drop to dangerous levels, potentially damaging organs. While giving fluids is a crucial part of treating septic shock, giving too much fluid can sometimes have harmful effects, especially on the kidneys, which might then need help from a machine (dialysis) to clean the blood.

Researchers are investigating whether a special type of ultrasound, called Venous Excess Ultrasound (VEXUS), can help doctors manage fluids more precisely. The idea is that VEXUS can show if blood vessels are becoming too full, indicating that the patient might have received enough fluid or even too much. By using this information, doctors might be able to prevent fluid overload, which could protect the kidneys and other organs.

This is a pilot study, meaning it's a smaller, early-stage trial. Its main purpose is to find out if it's practical to carry out a much larger study in the future. They want to know if it's possible to easily find patients for the study, get their permission, and follow the VEXUS-guided treatment plan. They will also look at early signs of whether VEXUS guidance truly improves patients' health and well-being compared to the standard ways doctors currently manage fluids.

Key takeaways

  • The study explores a new fluid management approach for septic shock using VEXUS ultrasound.
  • Septic shock is a severe infection causing dangerously low blood pressure.
  • Managing fluids carefully is crucial to protect kidneys and other organs.
  • This is a pilot study to see if a larger clinical trial is feasible.
  • Participants will be closely monitored for 28 days.

Who may be eligible?

This study is looking for adults aged 18 or older who have recently developed septic shock and have been admitted to intensive care. To be considered, you would need to have been diagnosed with septic shock within the last 12 hours and admitted to intensive care within the last 48 hours.

However, there are several reasons why someone might not be able to join. For example, if your kidneys are already severely affected and you're receiving dialysis, or if a decision has already been made to start dialysis, you wouldn't be able to participate. Also, if you have certain other serious conditions like severe burns, severe liver disease, or if you're receiving treatments that require constant fluid infusions, you wouldn't be eligible. The study also cannot include those who have life support limitations or certain heart problems.

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. Are you an adult aged 18 or older?
  2. Have you recently been diagnosed with septic shock?
  3. Were you admitted to intensive care recently (within 48 hours)?
  4. Are your kidneys not currently receiving dialysis?
  5. Do you have no other conditions that would prevent specific study activities?
Answer every question to see your result.

What does participation involve?

If you join this study, you would be put into one of two groups by chance: one group would receive fluid management guided by the VEXUS ultrasound, and the other group would receive the usual care your doctors would normally provide. If you're in the VEXUS group, you would have a VEXUS scan, which is a bit like a regular ultrasound, every 24 hours for three days. Based on what the VEXUS scan shows about the fluid in your blood vessels, doctors might adjust your fluid levels, for example, by limiting fluids or even removing some if necessary. You might also have a heart ultrasound if the VEXUS shows signs of fluid buildup.

Regardless of which group you are in, the study team would monitor your health for 28 days. This includes regularly checking your kidney function, seeing if you need dialysis, and overseeing your general well-being and recovery. There are no special medications involved; it's about how fluids are managed.

Potential risks and benefits

Taking part in this study could potentially offer benefits by helping doctors understand a new way to manage fluids in septic shock, which might reduce kidney problems. While the VEXUS scan itself is a non-invasive ultrasound, like those used for babies, there are no guaranteed personal benefits, and the study involves monitoring and changes to your usual care, which carries standard risks associated with intensive care treatment. You can decide to leave the study at any time, for any reason, and this will not affect the care you receive.

Locations (1)

  • London Health Sciences Center
    Verified postcode
    London, Canada

Common questions

What is septic shock?

Septic shock is a very dangerous condition where a severe infection in your body causes your blood pressure to drop very low, potentially damaging organs.

What is VEXUS?

VEXUS stands for Venous Excess Ultrasound. It's a special type of ultrasound that helps doctors see how much fluid is in your blood vessels to guide treatment.

Will I get a new medicine in this study?

No, this study doesn't involve new medicines. It's about a different way of guiding how doctors manage fluids you receive.

What does a 'pilot study' mean?

A pilot study is a small, early study designed to find out if a larger study is possible and practical to do in the future.

Can I leave the study if I change my mind?

Yes, you can choose to stop participating in the study at any time, and it won't affect the care you receive.

How to find out more

John Basmaji, 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 "Venous Excess Ultrasound for Personalized Resuscitation in S…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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