The Cold Fluids Study

Study Overview
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Brief Summary
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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.

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

Conditions
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Hemodynamic Instability

Intervention / Treatment
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* Drug: Ringer's Lactate


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cold-Warm<br>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) | Drug: Ringer's Lactate<br>* 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.<br>|
| Active Comparator: Warm-Cold<br>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), | Drug: Ringer's Lactate<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increase in MAP at 15 minutes after infusion of the fluid bolus. |  | 15 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time until return of MAP to baseline value after infusion. |  | 2 hours |