Hemodynamic Effects of Cold Versus Warm Fluid Bolus

Hypovolemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03209271
• Other study ID #: EPN 2016/986-31/1
• Status: Completed
• Phase: N/A
• First received: June 26, 2017
• Last updated: July 3, 2017
• Start date: February 3, 2017
• Est. completion date: May 27, 2017

Study information

• Verified date: July 2017
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: May 27, 2017
• Est. primary completion date: May 27, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Volunteers 18 years or older Previously healthy

Exclusion Criteria:

• American Society of Anesthesiologists classification 2 or above.

• Known pregnancy

Related Conditions & MeSH terms

• Body Temperature Changes
• Hypovolemia
• Temperature Change, Body

Intervention

Drug:
• Ringer's Acetate (warm)
Body temperature fluid
• Ringer's Acetate (cold)
Room temperature fluid

Locations

Country	Name	City	State
Sweden	Karolinska Institutet Södersjukhuset	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Time to return to baseline for CI	Time to return to baseline for CI	0-120 minutes
Other	Time to return to baseline for blood pressure	Time to return to baseline for blood pressure	0-120 minutes
Other	Time to return to baseline for heart rate	Time to return to baseline for heart rate	0-120 minutes
Other	Time to return to baseline for temperature	Time to return to baseline for temperature	0-120 minutes
Primary	Cardiac index 15 minutes	Change in cardiac index at 15 minutes from start of infusion	15 minutes
Secondary	Cardiac index 120 minutes	Change in cardiac index during 120 minutes from start of infusion	120 minutes
Secondary	Blood pressure 120 minutes	Change in blood pressure during 120 minutes from start of infusion	120 minutes
Secondary	Heart rate 120 minutes	Change in heart rate during 120 minutes from start of infusion	120 minutes
Secondary	Temperature 120 minutes	Change in body temperature during 120 minutes from start of infusion	120 minutes