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Completed

NCT Number: NCT05610254

The Cold Fluids Study

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.

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Key information

Conditions

Hemodynamic Instability

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Odense University Hospital

Odense, 5000, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ringer's Lactate

Drug

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.

Primary outcomes

  1. Increase in MAP at 15 minutes after infusion of the fluid bolus.

    Time frame: 15 minutes

Secondary outcomes

  1. Time until return of MAP to baseline value after infusion.

    Time frame: 2 hours

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Esbjerg Hospital - University Hospital of Southern Denmark

Other

Collaborators

  • Department of Clinical Biochemistry, Vejle Hospital
  • Odense University Hospital
  • Simon Fougner Hartmanns Family Foundation
  • University of Southern Denmark

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Nov 9, 2022
Registry last updated
Sep 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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