Rapid Infusion of Ringer's Lactate Solution at Different Temperatures and the Effects on Circulation and Perfusion in Healthy Volunteers - a Randomized Crossover Trial
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Increase in MAP at 15 minutes after infusion of the fluid bolus.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 64 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Cold-Warm
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)
Intervention: Ringer's Lactate (Drug)
Warm-Cold
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),
Intervention: Ringer's Lactate (Drug)
Outcomes
Primary Outcomes
Increase in MAP at 15 minutes after infusion of the fluid bolus.
Time Frame: 15 minutes
Secondary Outcomes
- Time until return of MAP to baseline value after infusion.(2 hours)