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Ongoing, recruitingTherapeutic use (Phase IV)Interventional

A randomized study to investigate central and cerebral hemodynamic effects and volume kinetics of Ringer´s Acetate compared with no intravenous fluids, during experimental hypovolemia compared with euvolemia, in healthy human volunteers.

Doctors are studying a common intravenous fluid called Ringer's Acetate. They want to see how it affects blood flow from the heart and the amount of fluid in your blood vessels in healthy volunteers. This includes looking at how quickly these things return to normal if someone has temporarily lost a little bit of fluid (like during dehydration). They'll compare this to people who haven't lost any fluid. The study will help us understand the best ways to use fluids in medical situations to help people recover. It's safe for healthy adults and is about understanding how the body reacts to these treatments.

At a glance

Status
Ongoing, recruiting
Phase
Therapeutic use (Phase IV)
Sponsor
Oslo University Hospital HF
Enrolment target
12
Start
26 Jun 2023

What is this study about?

Imagine you're really thirsty or have lost a bit of fluid, maybe after being very active. Your body needs fluids to work properly. Sometimes, in hospitals, doctors give fluids directly into your veins (intravenous fluids) to help your body recover. This study is looking at one very common type of fluid called Ringer's Acetate.

The main goal is to understand how this fluid affects two important things: how much blood your heart pumps with each beat (called 'cardiac stroke volume') and the total amount of fluid circulating in your blood vessels. They want to see how these measures change and how quickly they return to normal levels in healthy people. This is especially important for situations where someone might have temporarily lost some fluid from their body, a condition called 'hypovolemia'.

By comparing what happens when people receive Ringer's Acetate to when they don't get any fluids, the researchers can learn more about how our bodies deal with fluid changes. This kind of research is really important because it helps doctors make better decisions about how and when to give fluids to patients, ensuring they receive the best possible care.

Key takeaways

  • This study looks at how a common fluid drip affects blood movement and volume.
  • It helps us understand how our bodies react to fluid treatment.
  • Healthy adult volunteers (18+) are needed.
  • Both men and women can participate.
  • Your involvement helps improve future patient care.

Who may be eligible?

To join this study, you need to be a healthy adult.

You must be at least 18 years old. There isn't an upper age limit, but you'll need to be in good general health.

Both men and women are welcome to take part in this study.

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 18 years old or older?
  2. Are you generally in good health?
  3. Are you comfortable with receiving fluids through a drip?
  4. Are you able to attend clinic visits as required?
Answer every question to see your result.

What does participation involve?

The study involves a few visits to the research clinic. During your visits, researchers will assess your health and monitor your body's responses. You may have some blood samples taken and measurements of your heart activity. For some parts of the study, you might receive the Ringer's Acetate fluid through a drip in your arm, while at other times, you might not receive any intravenous fluids, so researchers can compare the effects. You will be closely monitored throughout these procedures. The exact number of visits and the total time you'll spend in the study will be explained in detail by the research team.

Potential risks and benefits

Participating in research always involves some level of risk, similar to routine medical procedures, such as discomfort from blood draws. However, this study involves healthy volunteers and a commonly used fluid, so serious risks are expected to be very low. There will be no direct personal benefit from taking part, but your contribution will help doctors better understand how to treat patients in the future. You are free to withdraw from the study at any time without giving a reason, and your medical care will not be affected.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Unverified
    Norway

Common questions

What is Ringer's Acetate?

It's a common type of fluid that's given intravenously (through a drip) in hospitals to help people stay hydrated or replace lost body fluids.

What does 'hypovolemia' mean?

It simply means you've temporarily lost a small amount of fluid from your body, which can happen if you're dehydrated or after certain medical events.

Will I feel unwell during the study?

You will be closely monitored by medical staff throughout the study. Any procedures will be explained, and your comfort and safety are a priority.

Why is this study important?

It helps doctors understand how the body reacts to fluid treatments, which can improve how patients are cared for in hospitals.

Do I have to take part?

No, taking part is completely voluntary. You can decide not to join, or you can leave the study at any time if you change your mind.

How to find out more

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

Discussion

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