Hemodynamic Effects of Cold Versus Warm Fluid Bolus

NCT ID: NCT03209271

Last Updated: 2017-07-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-03
• Study Completion Date: 2017-05-27

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.

Conditions

Temperature Change, Body; Hypovolemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Body temperature fluid

500ml Ringers Acetate infused over 15 minutes warmed to 38°C

Group Type: EXPERIMENTAL

Ringer's Acetate (warm)

Intervention Type: DRUG

Body temperature fluid

Room temperature fluid

500ml Ringers Acetate infused over 15 minutes cooled to 22°C

Group Type: ACTIVE_COMPARATOR

Ringer's Acetate (cold)

Intervention Type: DRUG

Room temperature fluid

Interventions

Ringer's Acetate (warm)

Body temperature fluid

Intervention Type: DRUG

Ringer's Acetate (cold)

Room temperature fluid

Intervention Type: DRUG

Other Intervention Names

Ringer-Acetat Baxter Viaflo, ATC B05BB01; Ringer-Acetat Baxter Viaflo, ATC B05BB01

Eligibility Criteria

Inclusion Criteria

• Volunteers 18 years or older Previously healthy

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Christer Svensen

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maria Cronhjort, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

Karolinska Institutet Södersjukhuset

Stockholm, , Sweden

Countries

Sweden

References

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.

Reference Type: DERIVED

PMID: 30482135 (View on PubMed)

Other Identifiers

EPN 2016/986-31/1

Identifier Type: -

Identifier Source: org_study_id