The Colder Fluids - Intravenous Infusion of 10 Degrees Celsius Fluids and Its Effects on Circulation and Hemostasis
Status:
COMPLETED
Trial end date:
2023-12-20
Target enrollment:
Participant gender:
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 (10C, 50F), or at room temperature (22C, 71,6F) 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
Phase:
PHASE1
Details
Lead Sponsor:
Esbjerg Hospital - University Hospital of Southern Denmark