drugset / Trial / NCT06622499

The Colder Fluids - Intravenous Infusion of 10 Degrees Celsius Fluids and Its Effects on Circulation and Hemostasis

NCT06622499

RandomizedCrossoverOpen-labelTreatment

Summary

The aim of this study is to investigate the effect of respectively 10 and 22 degrees Celsius Ringer's lactate solution on the physiological response in healthy adults. In a single center crossover study the investigators will include and randomize 25 healthy volunteers to receive 1 liter of Ringer's lactate either cold (10°C, 50°F), or at room temperature (22°C, 71,6°F) with 100 ml/min. Fluids will be administered through a peripheral vein. After a minimum "washout period" of 24 hours, subjects are switched to receive infusion at the other aforementioned temperatures. The main outcomes of this study are: Primary: • The increase in Mean Arterial Pressure (MAP) 30 minutes after started infusion Secondary: * Time until return of MAP to baseline value after infusion. * Changes in Visual Analog Scale (VAS) of discomfort during infusion * Changes in temperature, blood pressure, heart rate, peripheral oxygen saturation cardiac index, cardiac output, total peripheral resistance index and stroke volume * Changes in the intravascular volume status and the fluid responsiveness * Changes in biochemical parameters at baseline, 30 and 60 minutes. * Changes in Rotational thromboelastometry (ROTEM) analysis at baseline, 30 and 60 minutes

Timeline

Start
2023-11-06
Primary completion
2023-12-20
Completion
2023-12-20

Drugs

EvaluationDrugModalityDoseRoute
Comparator Ringer's Lactate Other / unclassified 1000 ml Intravenous

Indications

No indication recorded.