The Cold Fluids Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-24

Study Completion Date

2022-12-03

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.

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Detailed Description

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Conditions

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Hemodynamic Instability

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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)

Group Type ACTIVE_COMPARATOR

Ringer's Lactate

Intervention Type 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.

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),

Group Type ACTIVE_COMPARATOR

Ringer's Lactate

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes