Hemodynamic Effects of Cold Versus Warm Fluid Bolus

NCT03209271 | Completed DMC

• 1 other identifier: EPN 2016/986-31/1
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Temperature Change, Body; Hypovolemia

Keywords

Fluid therapy

Outcome Measures

Primary Outcomes (1)

• Cardiac index 15 minutes

  Change in cardiac index at 15 minutes from start of infusion

  15 minutes

Secondary Outcomes (4)

• Cardiac index 120 minutes

  120 minutes

• Blood pressure 120 minutes

  120 minutes

• Heart rate 120 minutes

  120 minutes

• Temperature 120 minutes

  120 minutes

Other Outcomes (4)

• Time to return to baseline for CI

  0-120 minutes

• Time to return to baseline for blood pressure

  0-120 minutes

• Time to return to baseline for heart rate

  0-120 minutes

Study Arms (2)

Body temperature fluid

EXPERIMENTAL

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

Drug: Ringer's Acetate (warm)

Room temperature fluid

ACTIVE COMPARATOR

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

Drug: Ringer's Acetate (cold)

Interventions

Ringer's Acetate (warm) DRUG

Body temperature fluid

Also known as: Ringer-Acetat Baxter Viaflo, ATC B05BB01

Body temperature fluid

Ringer's Acetate (cold) DRUG

Room temperature fluid

Also known as: Ringer-Acetat Baxter Viaflo, ATC B05BB01

Room temperature fluid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Volunteers 18 years or older Previously healthy

You may not qualify if:

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

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Karolinska Institutet Södersjukhuset

Stockholm, 118 83, Sweden

Location

Related Publications (1)

• 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.

  PMID: 30482135 DERIVED

MeSH Terms

Conditions

Body Temperature Changes; Hypovolemia

Interventions

Ringer's acetate; Cold Temperature

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Intervention Hierarchy (Ancestors)

Temperature; Thermodynamics; Physical Phenomena; Weather; Atmosphere; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Meteorological Concepts; Environment and Public Health

Study Officials

• Maria Cronhjort, MD, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Unblinded (unable to blind subjects)
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Crossover study of 2 different temperatures of crystalloid fluid bolus.

Study Record Dates

• First Submitted: June 26, 2017
• First Posted: July 6, 2017
• Study Start: February 3, 2017
• Primary Completion: May 27, 2017
• Study Completion: May 27, 2017
• Last Updated: July 6, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)