The Colder Fluids Study

Phase 1

Completed

• Conditions: Hemodynamic parameters is to be investigated -- comparing cold fluids 10 degrees celsius to room temperature 22 degrees celsius

• Registration Number: 2023-506018-35-00
• Lead Sponsor: Sydvestjysk Sygehus

Brief Summary

This randomized controlled crossover study investigates the effect of Ringer's lactate solution at high and low temperatures on physiological response in healthy adults.

Detailed Description

Not available

Study Timeline

• Study First Posted: 2023-09-08
• Last Update Posted: 2024-01-25

Recruitment & Eligibility

• Status: Ended
• Sex: Not specified
• Target Recruitment: 25

Inclusion Criteria

Age between 18-64

Exclusion Criteria

Pre-existing medical problems that are contraindicated for cold crystalloid infusions

Pregnancy (validated through a certified urine pregnancy test)

Body mass index >35 kg/m2

Medication use, including over-the-counter anti-pyretics within 48 hours, with exception of allergy medication and contraceptives.

Any family history or predisposition of coagulopathies

Any intake of inhibitors of 11β-Hydroxysteroid dehydrogenase the past 48 hours (products containing liquorice)

Study & Design

• Study Type: Not specified
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome of the study is the increase in mean arterial pressure (MAP) 30 minutes after started infusion of the fluid bolus measured via standard non-invasive blood pressure cuff.		The primary outcome of the study is the increase in mean arterial pressure (MAP) 30 minutes after started infusion of the fluid bolus measured via standard non-invasive blood pressure cuff.

Secondary Outcome Measures

Name	Time	Method
Time until return of MAP to baseline value after infusion.		Time until return of MAP to baseline value after infusion.
Changes in VAS during infusion		Changes in VAS 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 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 fluid responsiveness		Changes in the intravascular volume status and fluid responsiveness
Changes in biochemical parameters at baseline, 30 and 60 minutes		Changes in biochemical parameters at baseline, 30 and 60 minutes
Changes in ROTEM analysis at baseline, 30 and 60 minutes		Changes in ROTEM analysis at baseline, 30 and 60 minutes

Trial Locations

Locations (1)

Odense University Hospital; 🇩🇰 Odense C, Denmark

Odense University Hospital

🇩🇰Odense C, Denmark

Mikkel Brabrand

Site contact

+4540736373

mikkel.brabrand@rsyd.dk