Hemodynamic Effects of Cold Versus Warm Fluid Bolus

Study Overview
=================
Brief Summary
-----------------
Fluid boluses are often administered with the aim of improving tissue perfusion in critically ill patients. It is unclear whether the temperature of the fluid has an impact on the hemodynamic response. The aim of this study is to describe the hemodynamic effects of a fluid bolus with two different temperatures.

Detailed Description
-----------------
A randomized, controlled, cross-over study in 21 healthy volunteers. The participants will receive a fluid bolus of 500 ml Ringer's Acetate at either 22°C or 38°C over 15 minutes in a randomized order. Non-invasive measures will be made of cardiac index, mean arterial pressure, systolic blood pressure, diastolic blood pressure, heart and pulse rate, saturation and temperature. Hemodynamic measure will be made using the Clearsight® system. Measurements will be made during 120 minutes. The second session will take place at least one day later, and the participant will then receive the other fluid temperature.

Official Title
-----------------
Hemodynamic Effects of Cold Versus Warm Fluid Bolus Infusion in Healthy Volunteers: a Randomized Cross-over Trial

Conditions
-----------------
Temperature Change, Body, Hypovolemia

Intervention / Treatment
-----------------
* Drug: Ringer's Acetate (warm)
* Drug: Ringer's Acetate (cold)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Volunteers 18 years or older Previously healthy Exclusion Criteria: American Society of Anesthesiologists classification 2 or above. Known pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Crossover study of 2 different temperatures of crystalloid fluid bolus.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Body temperature fluid<br>500ml Ringers Acetate infused over 15 minutes warmed to 38°C | Drug: Ringer's Acetate (warm)<br>* Body temperature fluid<br>* Other names: Ringer-Acetat Baxter Viaflo, ATC B05BB01;|
| Active Comparator: Room temperature fluid<br>500ml Ringers Acetate infused over 15 minutes cooled to 22°C | Drug: Ringer's Acetate (cold)<br>* Room temperature fluid<br>* Other names: Ringer-Acetat Baxter Viaflo, ATC B05BB01;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac index 15 minutes | Change in cardiac index at 15 minutes from start of infusion | 15 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac index 120 minutes | Change in cardiac index during 120 minutes from start of infusion | 120 minutes | 
| Blood pressure 120 minutes | Change in blood pressure during 120 minutes from start of infusion | 120 minutes | 
| Heart rate 120 minutes | Change in heart rate during 120 minutes from start of infusion | 120 minutes | 
| Temperature 120 minutes | Change in body temperature during 120 minutes from start of infusion | 120 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fluid therapy