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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03209271
Enrollment
21
Registered
2017-07-06
Start date
2017-02-03
Completion date
2017-05-27
Last updated
2017-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypovolemia, Temperature Change, Body

Keywords

Fluid therapy

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.

Interventions

DRUGRinger's Acetate (warm)

Body temperature fluid

DRUGRinger's Acetate (cold)

Room temperature fluid

Sponsors

Karolinska Institutet
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE

Masking description

Unblinded (unable to blind subjects)

Intervention model description

Crossover study of 2 different temperatures of crystalloid fluid bolus.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

\- Volunteers 18 years or older Previously healthy

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Cardiac index 15 minutes15 minutesChange in cardiac index at 15 minutes from start of infusion

Secondary

MeasureTime frameDescription
Cardiac index 120 minutes120 minutesChange in cardiac index during 120 minutes from start of infusion
Blood pressure 120 minutes120 minutesChange in blood pressure during 120 minutes from start of infusion
Heart rate 120 minutes120 minutesChange in heart rate during 120 minutes from start of infusion
Temperature 120 minutes120 minutesChange in body temperature during 120 minutes from start of infusion

Other

MeasureTime frameDescription
Time to return to baseline for blood pressure0-120 minutesTime to return to baseline for blood pressure
Time to return to baseline for heart rate0-120 minutesTime to return to baseline for heart rate
Time to return to baseline for temperature0-120 minutesTime to return to baseline for temperature
Time to return to baseline for CI0-120 minutesTime to return to baseline for CI

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 22, 2026