Hemodynamic Effects of Cold Versus Warm Fluid Bolus

Not Applicable

Completed

• Conditions: Temperature Change, Body; Hypovolemia
• Interventions: Drug: Ringer's Acetate (warm); Drug: Ringer's Acetate (cold)

• Registration Number: NCT03209271
• Lead Sponsor: Karolinska Institutet

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-02-03
• Primary Completion: 2017-05-27
• Study Completion: 2017-05-27
• Study First Submitted: 2017-06-26
• Status Verified: 2017-07
• Study First Submitted QC: 2017-07-03
• Last Update Submitted: 2017-07-03
• Study First Posted: 2017-07-06
• Last Update Posted: 2017-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

• Volunteers 18 years or older Previously healthy

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Exclusion Criteria

• American Society of Anesthesiologists classification 2 or above.
• Known pregnancy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Body temperature fluid	Ringer's Acetate (warm)	500ml Ringers Acetate infused over 15 minutes warmed to 38°C
Room temperature fluid	Ringer's Acetate (cold)	500ml Ringers Acetate infused over 15 minutes cooled to 22°C

Primary Outcome Measures

Name	Time	Method
Cardiac index 15 minutes	15 minutes	Change in cardiac index at 15 minutes from start of infusion

Secondary Outcome Measures

Name	Time	Method
Cardiac index 120 minutes	120 minutes	Change in cardiac index during 120 minutes from start of infusion
Blood pressure 120 minutes	120 minutes	Change in blood pressure during 120 minutes from start of infusion
Heart rate 120 minutes	120 minutes	Change in heart rate during 120 minutes from start of infusion
Temperature 120 minutes	120 minutes	Change in body temperature during 120 minutes from start of infusion

Trial Locations

Locations (1)

Karolinska Institutet Södersjukhuset; 🇸🇪 Stockholm, Sweden