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SODIUM LACTATE (AS 50% SOLUTION)

Clinical trials investigating SODIUM LACTATE (AS 50% SOLUTION) are studying how fluid temperature affects the body’s response during infusion. The included study looks at healthy adults and measures safety-related physiological changes, especially blood pressure. The goal is to understand hemodynamic effects, such as mean arterial pressure.

Table of Contents

Trial overview

The available trial for SODIUM LACTATE (AS 50% SOLUTION) is called The Colder Fluids Study and it looked at how fluid temperature affects the body’s response during infusion.[1] The study compared cold fluid at 10 degrees Celsius with fluid at room temperature at 22 degrees Celsius.[1]

This study focused on hemodynamic parameters, which are measures of blood flow and blood pressure.[1] The brief summary says it was a randomized controlled crossover study in healthy adults.[1]

Study design and participants

The study was interventional, which means the researchers gave a fluid and observed what happened.[1] It used a randomized controlled crossover design, meaning the treatment order was chosen by chance and participants received the compared conditions in a crossover format.[1]

The target population was healthy adults.[1] The trial data do not list a disease condition or a special patient group beyond this healthy volunteer population.[1]

What was measured in the trial

The primary outcome was the increase in mean arterial pressure (MAP) 30 minutes after the fluid bolus started.[1] MAP is the average pressure in the arteries during a heartbeat cycle and is used to track circulation.[1]

The pressure was measured with a standard non-invasive blood pressure cuff.[1] This means the study used a cuff around the arm instead of a needle or invasive monitor.[1]

Trial phase and status

This study was in Phase 1, which is an early stage of clinical research.[1] Phase 1 studies often focus on how people respond to an intervention and on basic safety or body effects.[1]

The trial status is Completed, and the enrollment was 25 participants.[1]

Patient-focused terms

A fluid bolus is a larger amount of fluid given over a short time.[1] In this study, the fluid was given by intravenous infusion, which means directly into a vein.[1]

A crossover study helps compare two conditions in the same people, so each participant can serve as their own comparison.[1] This can help reduce differences between participants when looking at the study result.[1]

Trial ID Phase Condition studied Status Enrollment
2023-506018-35-00 Phase 1 Hemodynamic parameters; comparison of cold fluids at 10 degrees Celsius vs room temperature at 22 degrees Celsius Completed 25

FAQ

  • What clinical trial is studying SODIUM LACTATE (AS 50% SOLUTION)? The trial is a randomized crossover study called The Colder Fluids Study. It compares fluid given at 10 degrees Celsius with fluid at room temperature in healthy adults.
  • Who can take part in the study? The study population is healthy adults. The trial data do not list other specific patient groups.
  • What is the main goal of the trial? The main goal is to see how fluid temperature changes hemodynamic response, which means how the blood circulation system responds. The main measurement is mean arterial pressure after the infusion starts.
  • What phase is this trial? This is a Phase 1 trial. Phase 1 studies are usually early studies that look closely at how people respond to an intervention.
  • What outcome is being measured? The primary outcome is the increase in mean arterial pressure 30 minutes after the fluid bolus starts. It is measured with a standard non-invasive blood pressure cuff.

Ongoing Clinical Trials on SODIUM LACTATE (AS 50% SOLUTION)

  • Study on the Effects of Cold and Room Temperature Ringer’s Lactate Solution on Blood Flow and Clotting in Healthy Adults

    Not recruiting

    1 1 1 1
    Investigated drugs:
    Denmark

Glossary

  • Randomized controlled crossover study: A study design where participants receive more than one treatment in a set order, and the order is chosen by chance. This helps compare the effects more fairly.
  • Healthy adults: People without the condition being studied. In this trial, they are used to see how the body responds under normal conditions.
  • Hemodynamic response: Changes in blood flow and blood pressure in the body.
  • Mean arterial pressure (MAP): The average pressure in the arteries during one heartbeat cycle. It helps show how well blood is moving through the body.
  • Fluid bolus: A larger amount of fluid given over a short time.
  • Intravenous infusion: Fluid given directly into a vein.
  • Non-invasive blood pressure cuff: A cuff placed around the arm to measure blood pressure without needles or surgery.
  • Phase 1: An early stage of clinical research that usually looks at how people respond to a study treatment and checks basic safety and body effects.

References