The Cold Fluids Study

Esbjerg Hospital - University Hospital of Southern Denmark

Status and phase: Completed; Phase 4

Conditions: Hemodynamic Instability

Treatments: Drug: Ringer's Lactate

Study type: Interventional

Funder types: Other

Identifiers

NCT05610254

2022-002137-34

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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18 participants in 2 patient groups

Cold-Warm

Active Comparator group

Description:

Trial day 1: Participants receive Ringer's lactate cold (15°C, 59°F), Trial day 2: Participants receive Ringer's lactate at body temperature (37°C, 98.6°F)

Treatment:

Drug: Ringer's Lactate

Warm-Cold

Active Comparator group

Description:

Trial day 1: Participants receive Ringer's lactate at body temperature (37°C, 98.6°F) Trial day 2: Participants receive Ringer's lactate cold (15°C, 59°F),

Treatment:

Drug: Ringer's Lactate