Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Hemodynamic Effects of Cold Versus Warm Fluid Bolus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03209271
Recruitment Status : Completed
First Posted : July 6, 2017
Last Update Posted : July 6, 2017
Sponsor:
Information provided by (Responsible Party):
Christer Svensen, Karolinska Institutet

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.

Condition or disease Intervention/treatment Phase
Temperature Change, Body Hypovolemia Drug: Ringer's Acetate (warm) Drug: Ringer's Acetate (cold) Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Crossover study of 2 different temperatures of crystalloid fluid bolus.
Masking: None (Open Label)
Masking Description: Unblinded (unable to blind subjects)
Primary Purpose: Basic Science
Official Title: Hemodynamic Effects of Cold Versus Warm Fluid Bolus Infusion in Healthy Volunteers: a Randomized Cross-over Trial
Actual Study Start Date : February 3, 2017
Actual Primary Completion Date : May 27, 2017
Actual Study Completion Date : May 27, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Body temperature fluid
500ml Ringers Acetate infused over 15 minutes warmed to 38°C
Drug: Ringer's Acetate (warm)
Body temperature fluid
Other Name: Ringer-Acetat Baxter Viaflo, ATC B05BB01

Active Comparator: Room temperature fluid
500ml Ringers Acetate infused over 15 minutes cooled to 22°C
Drug: Ringer's Acetate (cold)
Room temperature fluid
Other Name: Ringer-Acetat Baxter Viaflo, ATC B05BB01




Primary Outcome Measures :
  1. Cardiac index 15 minutes [ Time Frame: 15 minutes ]
    Change in cardiac index at 15 minutes from start of infusion


Secondary Outcome Measures :
  1. Cardiac index 120 minutes [ Time Frame: 120 minutes ]
    Change in cardiac index during 120 minutes from start of infusion

  2. Blood pressure 120 minutes [ Time Frame: 120 minutes ]
    Change in blood pressure during 120 minutes from start of infusion

  3. Heart rate 120 minutes [ Time Frame: 120 minutes ]
    Change in heart rate during 120 minutes from start of infusion

  4. Temperature 120 minutes [ Time Frame: 120 minutes ]
    Change in body temperature during 120 minutes from start of infusion


Other Outcome Measures:
  1. Time to return to baseline for CI [ Time Frame: 0-120 minutes ]
    Time to return to baseline for CI

  2. Time to return to baseline for blood pressure [ Time Frame: 0-120 minutes ]
    Time to return to baseline for blood pressure

  3. Time to return to baseline for heart rate [ Time Frame: 0-120 minutes ]
    Time to return to baseline for heart rate

  4. Time to return to baseline for temperature [ Time Frame: 0-120 minutes ]
    Time to return to baseline for temperature



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

- Volunteers 18 years or older Previously healthy

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03209271


Locations
Layout table for location information
Sweden
Karolinska Institutet Södersjukhuset
Stockholm, Sweden, 118 83
Sponsors and Collaborators
Karolinska Institutet
Investigators
Layout table for investigator information
Principal Investigator: Maria Cronhjort, MD, PhD Karolinska Institutet
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Christer Svensen, Professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT03209271    
Other Study ID Numbers: EPN 2016/986-31/1
First Posted: July 6, 2017    Key Record Dates
Last Update Posted: July 6, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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
Keywords provided by Christer Svensen, Karolinska Institutet:
Fluid therapy
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypovolemia
Body Temperature Changes
Pathologic Processes