Hemodynamic Effects of Cold Versus Warm Fluid Bolus

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

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.

Study Overview

• Status: Completed
• Conditions: Temperature Change, Body; Hypovolemia
• Intervention / Treatment: Drug: Ringer's Acetate (warm); Drug: Ringer's Acetate (cold)

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.

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden, 118 83
    • Karolinska institutet södersjukhuset

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

- Volunteers 18 years or older Previously healthy

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to return to baseline for CI	Time to return to baseline for CI	0-120 minutes
Time to return to baseline for blood pressure	Time to return to baseline for blood pressure	0-120 minutes
Time to return to baseline for heart rate	Time to return to baseline for heart rate	0-120 minutes
Time to return to baseline for temperature	Time to return to baseline for temperature	0-120 minutes

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Investigators: Principal Investigator: Maria Cronhjort, MD, PhD, Karolinska Institutet

Publications and helpful links

General Publications

• Wall O, Ehrenberg L, Joelsson-Alm E, Martensson J, Bellomo R, Svensen C, Cronhjort M. Haemodynamic effects of cold versus warm fluid bolus in healthy volunteers: a randomised crossover trial. Crit Care Resusc. 2018 Dec;20(4):277-284.

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2017
• Primary Completion (Actual): May 27, 2017
• Study Completion (Actual): May 27, 2017

Study Registration Dates

• First Submitted: June 26, 2017
• First Submitted That Met QC Criteria: July 3, 2017
• First Posted (Actual): July 6, 2017

Study Record Updates

• Last Update Posted (Actual): July 6, 2017
• Last Update Submitted That Met QC Criteria: July 3, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Fluid therapy
• Additional Relevant MeSH Terms: Pathologic Processes; Hypovolemia; Body Temperature Changes
• Other Study ID Numbers: EPN 2016/986-31/1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No