In short
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.
Key points
- SODIUM LACTATE (AS 50% SOLUTION) is being studied in a small Phase 1 trial in healthy adults. The study compares cold fluid with room-temperature fluid to see how temperature changes the body’s circulation response. The main outcome is mean arterial pressure 30 minutes after infusion begins. This trial is completed and included 25 participants. It focuses on hemodynamic parameters, which means measures of blood flow and blood pressure.
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. The study compared cold fluid at 10 degrees Celsius with fluid at room temperature at 22 degrees Celsius.
This study focused on hemodynamic parameters, which are measures of blood flow and blood pressure. The brief summary says it was a randomized controlled crossover study in healthy adults.
Study design and participants
The study was interventional, which means the researchers gave a fluid and observed what happened. 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.
The target population was healthy adults. The trial data do not list a disease condition or a special patient group beyond this healthy volunteer population.
What was measured in the trial
The primary outcome was the increase in mean arterial pressure (MAP) 30 minutes after the fluid bolus started. MAP is the average pressure in the arteries during a heartbeat cycle and is used to track circulation.
The pressure was measured with a standard non-invasive blood pressure cuff. This means the study used a cuff around the arm instead of a needle or invasive monitor.
Trial phase and status
This study was in Phase 1, which is an early stage of clinical research. Phase 1 studies often focus on how people respond to an intervention and on basic safety or body effects.
The trial status is Completed, and the enrollment was 25 participants.
Patient-focused terms
A fluid bolus is a larger amount of fluid given over a short time. In this study, the fluid was given by intravenous infusion, which means directly into a vein.
A crossover study helps compare two conditions in the same people, so each participant can serve as their own comparison. This can help reduce differences between participants when looking at the study result.