NCT06622499

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

Rapid Intravenous Infusion of 10 and 22 Degrees Celsius Ringer's Lactate in Healthy Volunteers and Its Effects on Circulation and Hemostasis - a Randomized Crossover Trial

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Esbjerg Hospital - University Hospital of Southern Denmark · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

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

Conditions

• Hemodynamic Instability

Interventions

Type	Name	Description
DRUG	Ringer's Lactate	On the first trial day healthy volunteers are randomized 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. After a minimum "washout period" of 24 hours, subjects are switched to receive infusion at the other aforementioned temperatures.

Timeline

• Start date: 2023-11-06
• Primary completion: 2023-12-20
• Completion: 2023-12-20
• First posted: 2024-10-02
• Last updated: 2024-10-08

Locations

1 site across 1 country: Denmark