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Completed
NCT05610254
The Cold Fluids Study
Conditions: Hemodynamic Instability
Sex: All
Ages: 18 Years – 64 Years
Healthy volunteers: 1
Phase: PHASE4
Enrollment: 18
Sponsor: Hospital of South West Jutland
Location: Denmark
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 isThe increase in MAP at 15 minutes after infusion of the fluid bolus.
Secondary outcome isTime until return of MAP to baseline value after infusion.
Eligibility Criteria
Inclusion Criteria:Age between 18-64Exclusion Criteria:Pre-existing medical problemsPregnancy (validated through a certified pregnancy test)Body mass index >35 kg/m2Medication use apart from allergy medication, contraceptives, or non-steroidal anti-inflammatory drugs.
Source: ClinicalTrials.gov (NCT05610254). StuddyBuddy aggregates publicly available trial information.