The Cold Fluids Study

Phase 4

Completed

• Conditions: Hemodynamic Instability
• Interventions: Drug: Ringer's Lactate

• Registration Number: NCT05610254
• Lead Sponsor: Esbjerg Hospital - University Hospital of Southern Denmark

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-24
• Study First Submitted: 2022-11-02
• Study First Submitted QC: 2022-11-02
• Study First Posted: 2022-11-09
• Primary Completion: 2022-12-03
• Study Completion: 2022-12-03
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-27
• Last Update Posted: 2023-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Cold-Warm	Ringer's Lactate	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)
Warm-Cold	Ringer's Lactate	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),

Primary Outcome Measures

Name	Time	Method
Increase in MAP at 15 minutes after infusion of the fluid bolus.	15 minutes

Secondary Outcome Measures

Name	Time	Method
Time until return of MAP to baseline value after infusion.	2 hours

Trial Locations

Locations (1)

Odense University Hospital; 🇩🇰 Odense, Denmark