The Cold Fluids Study

• Status: Recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Hospital of South West Jutland
• Collaborators: Department of Clinical Biochemistry, Vejle Hospital; Odense University Hospital; Simon Fougner Hartmanns Family Foundation; University of Southern Denmark

Criteria

Inclusion Criteria:

• Age between 18-64

Exclusion Criteria:

• 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.