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OpenTrials
Completed

NCT Number: NCT03209271

Hemodynamic Effects of Cold Versus Warm Fluid Bolus

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.

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Key information

Conditions

Temperature Change, Body Body Temperature Changes Hypovolemia Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karolinska Institutet Södersjukhuset

Stockholm, 118 83, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Volunteers 18 years or older Previously healthy

Exclusion criteria

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

Treatment and study plan

Ringer's Acetate (warm)

Drug

Body temperature fluid

Other names: Ringer-Acetat Baxter Viaflo, ATC B05BB01

Ringer's Acetate (cold)

Drug

Room temperature fluid

Other names: Ringer-Acetat Baxter Viaflo, ATC B05BB01

Primary outcomes

  1. Cardiac index 15 minutes

    Time frame: 15 minutes

    Change in cardiac index at 15 minutes from start of infusion

Secondary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

Hemodynamic Effects of Cold Versus Warm Fluid Bolus Infusion in Healthy Volunteers: a Randomized Cross-over Trial

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jul 6, 2017
Registry last updated
Jul 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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