Odense University Hospital
Odense, Denmark
Not recruiting
Study on the Effects of Cold and Room Temperature Ringer's Lactate Solution on Blood Flow and Clotting in Healthy Adults
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What is this trial about?
A plain-language summary of the goals, design and what participants do
The study focuses on understanding how different temperatures of a fluid called Ringer's lactate affect the body. Ringer's lactate is a solution used in medical settings to provide essential minerals and fluids to the body. It contains substances like potassium chloride, sodium chloride, calcium chloride dihydrate, and sodium lactate. The study will compare the effects of this solution when it is cooled to 10 degrees Celsius versus when it is at room temperature, which is 22 degrees Celsius.
The purpose of the study is to see how these different temperatures of Ringer's lactate affect healthy adults, particularly looking at how it influences blood circulation and the body's ability to stop bleeding, known as hemostasis. Participants will receive the solution through an intravenous infusion, which means it will be delivered directly into the bloodstream through a vein. The study will observe changes in blood pressure, heart rate, and other related factors to understand the body's response to the fluid at different temperatures.
This research is designed as a randomized crossover trial, meaning participants will receive both temperature variations of the solution at different times. The main focus is to measure changes in mean arterial pressure, which is a type of blood pressure, 30 minutes after the infusion starts. Other observations will include how long it takes for blood pressure to return to normal, changes in body temperature, and other physiological responses. The study aims to provide insights into how temperature variations in medical fluids can impact the body's functions.
The research process
The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
3 criteria
- Age between 18 and 64 years old.
- Both male and female participants are eligible.
- Participants should be healthy adults, meaning they do not have any significant health issues.
Who cannot join the trial?
3 criteria
- Individuals who are not considered healthy adults cannot participate. This means you should not have any ongoing health issues.
- Participants must be within a specific age range. If you are too young or too old, you may not be eligible.
- People who are part of a vulnerable population are not allowed to join. This includes groups who might need special protection or care.
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Investigated drugs
Ringer's Lactate Solution is a type of fluid that is often used in medical settings to help maintain the body's fluid balance. It contains a mix of water and important salts, similar to the natural fluids in your body. In this trial, the solution is being tested at two different temperatures, 10 degrees Celsius and 22 degrees Celsius, to see how these temperatures affect blood circulation and the body's ability to stop bleeding in healthy adults. The goal is to understand how the temperature of the solution might change its effects on the body when given through a vein. This information could help improve how fluids are used in medical treatments.
What is already known about the treatment
Ringer's lactate solution – This medication is administered intravenously, meaning it is given directly into a vein through an IV. It is currently being studied in clinical trials to understand its effects on blood flow and clotting when infused at different temperatures, specifically 10 degrees Celsius and 22 degrees Celsius. The main therapeutic use of Ringer's lactate is to restore fluids and electrolytes in the body, often used in situations like dehydration or surgery. At the molecular level, it works by providing essential ions and maintaining the body's acid-base balance. It is classified pharmacologically as a crystalloid solution, which is a type of fluid used to replace lost body fluids.
Investigated diseases
Hemodynamic Parameters – Hemodynamic parameters refer to the various measurements that assess the blood flow and pressure within the cardiovascular system. These parameters include mean arterial pressure, heart rate, cardiac output, and peripheral oxygen saturation, among others. Changes in these parameters can indicate how well the heart is pumping blood and how effectively the blood vessels are functioning. The progression of hemodynamic changes can be influenced by factors such as fluid volume, temperature, and the body's physiological response to different conditions. Monitoring these parameters helps in understanding the body's circulatory status and can guide medical interventions.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2023-506018-35-00Protocol codeSVS.FAM.02Estimated enrolment25 patientsSponsorEsbjerg Og Grindsted Sygehus
sourced from the EU Clinical Trials Register and site verification
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