Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

Rapid intravenous infusion of 10 and 22 degrees Celcius Ringer's lactate in healthy volunteers and its effects on circulation and hemostasis - a randomized crossover trial

This study is investigating how giving fluids intravenously (by a drip) affects healthy people. Specifically, researchers want to compare two different temperatures of a commonly used fluid called Ringer's lactate: a cool 10°C and a room temperature 22°C. The main thing they're looking at is if there's a difference in blood pressure 30 minutes after the fluid starts to be given. They will also check other things like heart rate, body temperature, and how blood clots. This is an early phase study, meaning it's a first look at how these fluid temperatures might affect the body.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Sydvestjysk Sygehus

Enrolment target

Start

08 Sep 2023

Hemodynamic parameters is to be investigated -- comparing cold fluids 10 degrees celsius to room temperature 22 degrees celsius

What is this study about?

This study is all about understanding how our bodies react when we receive fluids through a drip, which is a common medical procedure. The researchers are particularly interested in the temperature of the fluid. They want to see if there's a difference in how our circulation (like blood pressure and heart rate) and our blood's ability to clot (hemostasis) respond when we receive cool fluid (around 10 degrees Celsius, like a cold drink) compared to fluid at room temperature (around 22 degrees Celsius).

The fluid being used is called Ringer's lactate, which is a very standard fluid given in hospitals to many patients. Because this is an early-stage study, it's being done on healthy volunteers. This helps the researchers understand the basic effects of the fluid temperatures without other health conditions getting in the way.

The main goal is to check what happens to your blood pressure 30 minutes after the fluid starts. They will also measure other important signs like your heart rate, body temperature, and how quickly your blood clots. Understanding these effects is important for doctors to know the best way to give fluids to patients in different situations.

Key takeaways

This study compares how cool versus room temperature fluid via drip affects healthy people.
It's looking for changes in blood pressure, heart rate, and other body functions.
The fluid used is Ringer's lactate, a common solution in hospitals.
It's an early-stage study (Phase I) on healthy adults.
Your participation could help improve future medical care.

Who may be eligible?

To take part in this study, you need to be an adult, 18 years old or older. The study is open to both men and women.

Since this is an early-stage study and looks at how healthy bodies react, people with certain health conditions might not be able to join. The research team will speak with you to make sure it's safe for you to participate.

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.

Are you 18 years old or older?
Are you generally healthy?
Are you willing to receive fluids through a drip?
Are you comfortable with blood pressure and blood sample measurements?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive the Ringer's lactate fluid through a drip. During this time, researchers would take measurements of your blood pressure frequently using a standard cuff. They would also monitor your heart rate, body temperature, and take some blood samples to check for changes.

You would experience receiving the fluid at both 10°C and 22°C, but not at the same time. This is called a 'crossover' study, meaning you act as your own comparison. The total duration of your participation, including any follow-up, would be fully explained by the study team.

Potential risks and benefits

Taking part in any study has potential benefits and risks. You might not directly benefit from this study, but your participation will help doctors better understand how fluid temperature affects the body, which could improve patient care in the future. Potential risks could include discomfort from the drip insertion, temporary changes in blood pressure, or feeling cold or warm during the infusion. All known risks will be thoroughly explained to you, and you have the right to withdraw from the study at any time without giving a reason, and it won't affect your future medical care.

Locations (1)

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

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Unverified
Denmark

Common questions

What is Ringer's lactate?

Ringer's lactate is a common salt-water solution given through a drip to rehydrate patients or as a fluid replacement.

Why are you looking at fluid temperature?

Researchers want to understand if the temperature of the fluid given through a drip affects how your body, especially your blood pressure and circulation, responds.

Will I feel cold during the infusion?

You might feel a temporary sensation of coldness when receiving the 10°C fluid. The research team will monitor your comfort closely.

What does 'crossover trial' mean?

It means you will experience both fluid temperatures (10°C and 22°C) at different times during the study, allowing researchers to compare the effects on you individually.

How long will I be involved in the study?

The study team will explain the exact time commitment, including how long the infusions and monitoring periods will be. It will likely involve a few visits.