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The Cold Fluids Study

NCT05610254 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2024-09-05

No results posted yet for this study

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.

Conditions

  • Hemodynamic Instability

Interventions

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.

Sponsors & Collaborators

  • Odense University Hospital

    collaborator OTHER

  • University of Southern Denmark

    collaborator OTHER

  • Simon Fougner Hartmanns Family Foundation

    collaborator UNKNOWN

  • Department of Clinical Biochemistry, Vejle Hospital

    collaborator UNKNOWN

  • Esbjerg Hospital - University Hospital of Southern Denmark

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-10-24
Primary Completion
2022-12-03
Completion
2022-12-03

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05610254 on ClinicalTrials.gov