The Cold Fluids Study

Hemodynamic Instability Clinical Trial

Official title:

Rapid Infusion of Ringer's Lactate Solution at Different Temperatures and the Effects on Circulation and Perfusion in Healthy Volunteers - a Randomized Crossover Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05610254
• Other study ID #: 2022-002137-34
• Status: Completed
• Phase: Phase 4
• Start date: October 24, 2022
• Est. completion date: December 3, 2022

Study information

• Verified date: January 2023
• Source: Hospital of South West Jutland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: December 3, 2022
• Est. primary completion date: December 3, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hemodynamic Instability

Intervention

Drug:
• Ringer'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.

Locations

Country	Name	City	State
Denmark	Odense University Hospital	Odense

Sponsors (5)

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

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increase in MAP at 15 minutes after infusion of the fluid bolus.		15 minutes
Secondary	Time until return of MAP to baseline value after infusion.		2 hours