Back to resultsHemodynamic Effects of Cold Versus Warm Fluid Bolus
Primary Purpose
Temperature Change, Body, Hypovolemia
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Ringer's Acetate (warm)
Ringer's Acetate (cold)
Sponsored by
About this trial
This is an interventional basic science trial for Temperature Change, Body focused on measuring Fluid therapy
Eligibility Criteria
Inclusion Criteria:
- Volunteers 18 years or older Previously healthy
Exclusion Criteria:
- American Society of Anesthesiologists classification 2 or above.
- Known pregnancy
Sites / Locations
- Karolinska Institutet Södersjukhuset
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Body temperature fluid
Room temperature fluid
Arm Description
500ml Ringers Acetate infused over 15 minutes warmed to 38°C
500ml Ringers Acetate infused over 15 minutes cooled to 22°C
Outcomes
Primary Outcome Measures
Cardiac index 15 minutes
Change in cardiac index at 15 minutes from start of infusion
Secondary Outcome Measures
Cardiac index 120 minutes
Change in cardiac index during 120 minutes from start of infusion
Blood pressure 120 minutes
Change in blood pressure during 120 minutes from start of infusion
Heart rate 120 minutes
Change in heart rate during 120 minutes from start of infusion
Temperature 120 minutes
Change in body temperature during 120 minutes from start of infusion
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03209271
Brief Title
Hemodynamic Effects of Cold Versus Warm Fluid Bolus
Official Title
Hemodynamic Effects of Cold Versus Warm Fluid Bolus Infusion in Healthy Volunteers: a Randomized Cross-over Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
February 3, 2017 (Actual)
Primary Completion Date
May 27, 2017 (Actual)
Study Completion Date
May 27, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temperature Change, Body, Hypovolemia
Keywords
Fluid therapy
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Crossover study of 2 different temperatures of crystalloid fluid bolus.
Masking
None (Open Label)
Masking Description
Unblinded (unable to blind subjects)
Allocation
Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Body temperature fluid
Arm Type
Experimental
Arm Description
500ml Ringers Acetate infused over 15 minutes warmed to 38°C
Arm Title
Room temperature fluid
Arm Type
Active Comparator
Arm Description
500ml Ringers Acetate infused over 15 minutes cooled to 22°C
Intervention Type
Drug
Intervention Name(s)
Ringer's Acetate (warm)
Other Intervention Name(s)
Ringer-Acetat Baxter Viaflo, ATC B05BB01
Intervention Description
Body temperature fluid
Intervention Type
Drug
Intervention Name(s)
Ringer's Acetate (cold)
Other Intervention Name(s)
Ringer-Acetat Baxter Viaflo, ATC B05BB01
Intervention Description
Room temperature fluid
Primary Outcome Measure Information:
Title
Cardiac index 15 minutes
Description
Change in cardiac index at 15 minutes from start of infusion
Time Frame
15 minutes
Secondary Outcome Measure Information:
Title
Cardiac index 120 minutes
Description
Change in cardiac index during 120 minutes from start of infusion
Time Frame
120 minutes
Title
Blood pressure 120 minutes
Description
Change in blood pressure during 120 minutes from start of infusion
Time Frame
120 minutes
Title
Heart rate 120 minutes
Description
Change in heart rate during 120 minutes from start of infusion
Time Frame
120 minutes
Title
Temperature 120 minutes
Description
Change in body temperature during 120 minutes from start of infusion
Time Frame
120 minutes
Other Pre-specified Outcome Measures:
Title
Time to return to baseline for CI
Description
Time to return to baseline for CI
Time Frame
0-120 minutes
Title
Time to return to baseline for blood pressure
Description
Time to return to baseline for blood pressure
Time Frame
0-120 minutes
Title
Time to return to baseline for heart rate
Description
Time to return to baseline for heart rate
Time Frame
0-120 minutes
Title
Time to return to baseline for temperature
Description
Time to return to baseline for temperature
Time Frame
0-120 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
- Volunteers 18 years or older Previously healthy
Exclusion Criteria:
American Society of Anesthesiologists classification 2 or above.
Known pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Cronhjort, MD, PhD
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karolinska Institutet Södersjukhuset
City
Stockholm
ZIP/Postal Code
118 83
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30482135
Citation
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.
Results Reference
derived
Learn more about this trial
Hemodynamic Effects of Cold Versus Warm Fluid Bolus
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