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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05610254

Enrollment

Registered

2022-11-09

Start date

2022-10-24

Completion date

2022-12-03

Last updated

2024-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemodynamic Instability

Brief 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.

Interventions

DRUGRinger'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.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 64 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Increase in MAP at 15 minutes after infusion of the fluid bolus.	15 minutes

Secondary

Measure	Time frame
Time until return of MAP to baseline value after infusion.	2 hours

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026