NCT05610254

The Cold Fluids Study

Rapid Infusion of Ringer's Lactate Solution At Different Temperatures and the Effects on Circulation and Perfusion in Healthy Volunteers - a Randomized Crossover Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Esbjerg Hospital - University Hospital of Southern Denmark · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

Summary

In this single center crossover study the aim is to investigate the effect of Ringer's lactate solution at high and low temperatures on physiological response in healthy adults.18 healthy volunteers will be included. Inclusion criteria is; Age between 18-64. Exclusion criteria is; Pre-existing medical problems, Pregnancy (validated through a certified pregnancy test), Body mass index \>35 kg/m2, Medication use apart from allergy medication, contraceptives, or non-steroidal anti-inflammatory drugs. Participants will be randomized to receive 30 ml/kg of Ringer's lactate either cold (15°C, 59°F), or at body temperature (37°C, 98.6°F) during a 30-minute interval. 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. Primary outcome is * The increase in MAP at 15 minutes after infusion of the fluid bolus. Secondary outcome is * Time until return of MAP to baseline value after infusion.

Conditions

• Hemodynamic Instability

Interventions

Type	Name	Description
DRUG	Ringer's Lactate	On the first trial day healthy volunteers are randomized to receive 30 ml/kg of Ringer's lactate either cold (15°C, 59°F), or at body temperature (37°C, 98.6°F) during a 30-minute interval. After a minimum "washout period" of 24 hours, subjects are switched to receive infusion at the other aforementioned temperatures.

Timeline

• Start date: 2022-10-24
• Primary completion: 2022-12-03
• Completion: 2022-12-03
• First posted: 2022-11-09
• Last updated: 2024-09-05

Locations

1 site across 1 country: Denmark