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Completed

NCT Number: NCT06622499

The Colder Fluids - Intravenous Infusion of 10 Degrees Celsius Fluids and Its Effects on Circulation and Hemostasis

The aim of this study is to investigate the effect of respectively 10 and 22 degrees Celsius Ringer's lactate solution on the physiological response in healthy adults. In a single center crossover study the investigators will include and randomize 25 healthy volunteers to receive 1 liter of Ringer's lactate either cold (10°C, 50°F), or at room temperature (22°C, 71,6°F) with 100 ml/min. Fluids will be administered through a peripheral vein. After a minimum "washout period" of 24 hours, subjects are switched to receive infusion at the other aforementioned temperatures.

The main outcomes of this study are:

Primary:

• The increase in Mean Arterial Pressure (MAP) 30 minutes after started infusion

Secondary:

* Time until return of MAP to baseline value after infusion. * Changes in Visual Analog Scale (VAS) of discomfort during infusion * Changes in temperature, blood pressure, heart rate, peripheral oxygen saturation cardiac index, cardiac output, total peripheral resistance index and stroke volume * Changes in the intravascular volume status and the fluid responsiveness * Changes in biochemical parameters at baseline, 30 and 60 minutes. * Changes in Rotational thromboelastometry (ROTEM) analysis at baseline, 30 and 60 minutes

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Key information

Conditions

Hemodynamic Instability

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Odense University Hospital

Odense, 5000, Denmark

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age between 18-64

Exclusion criteria

  • Pre-existing medical problems that are contraindicated for cold crystalloid infusions.
  • Pregnancy (validated through a certified urine pregnancy test)
  • Body mass index >35 kg/m2
  • Medication use, including over-the-counter anti-pyretics within 48 hours, with exception of allergy medication and contraceptives.
  • Any family history or predisposition of coagulopathies.
  • Any intake of inhibitors of 11β-Hydroxysteroid dehydrogenase the past 48 hours (products containing liquorice)

Treatment and study plan

Ringer's Lactate

Drug

On the first trial day healthy volunteers are randomized to receive 1 liter of Ringer's lactate either cold (10°C, 50°F), or at room temperature (22°C, 71.6°F) with 100 ml/min. After a minimum "washout period" of 24 hours, subjects are switched to receive infusion at the other aforementioned temperatures.

Primary outcomes

  1. Increase in Mean Arterial Pressure (MAP) 30 minutes after started infusion

    Time frame: Trial day 1 & Trial day 2

Secondary outcomes

  1. Time until return of Mean Arterial Pressure (MAP) to baseline value after infusion

    Time frame: Trial day 1 & Trial day 2

  2. Changes in Visual Analog Scale (VAS) of discomfort during infusion

    Time frame: Trial day 1 & Trial day 2

    Visual analoge scale of discomfort to assess participants discomfort during the trial. A scale labelled from 0=no discomfort to 10=maximum discomfort imaginable.

  3. Changes in physiological parameter temperature measured in degrees Celcius

    Time frame: Trial day 1 & Trial day 2

  4. Changes in physiological parameter blood pressure measured in millimeter of mercury (mmHg)

    Time frame: Trial day 1 & Trial day 2

  5. Changes in physiological parameter peripheral oxygen saturation measured in percent (%)

    Time frame: Trial day 1 & Trial day 2

  6. Changes in physiological parameter cardiac index measured in L/min/m2

    Time frame: Trial day 1 & Trial day 2

  7. Changes in physiological parameter cardias output measured in L/min

    Time frame: Trial day 1 & Trial day 2

  8. Changes in physiological parameter total peripheral resistance index measured in dyn·s/cm5

    Time frame: Trial day 1 & Trial day 2

  9. Changes in physiological parameter stroke volume measured in mL

    Time frame: Trial day 1 & Trial day 2

  10. Changes in physiological parameter intravascular volume status and fluid responsiveness measured in vena cava inferior maximum diameter and index via ultrasound

    Time frame: Trial day 1 & Trial day 2

  11. Changes in physiological parameter of INR blood test measured in prothrombin time at baseline, after 30 minutes and after 60 minutes

    Time frame: Trial day 1 & Trial day 2

  12. Changes in physiological parameter APTT blood test measured in seconds at baseline, after 30 minutes and after 60 minutes

    Time frame: Trial day 1 & Trial day 2

  13. Changes in physiological parameter Fibrinogen blood test measured in µmol/L at baseline, after 30 minutes and after 60 minutes

    Time frame: Trial day 1 & Trial day 2

  14. Changes in physiological parameter Platelet count blood test measured in 109/L at baseline, after 30 minutes and after 60 minutes

    Time frame: Trial day 1 & Trial day 2

  15. Changes in physiological parameter Flowcytometry blood tests (CD63, CD62p, PAC-1) measured in % at baseline, after 30 minutes and after 60 minutes

    Time frame: Trial day 1 & Trial day 2

  16. Changes in physiological parameter Rotational thromboelastometry (EXTEM, INTEM, FIBTEM analysis of Clotting time and maximum clot formation) measured in seconds and millimeters, respectively, at baseline, after 30 minutes and after 60 minutes

    Time frame: Trial day 1 & Trial day 2

Sponsors and collaborators

Lead sponsor

Esbjerg Hospital - University Hospital of Southern Denmark

Other

Collaborators

  • Odense University Hospital

Registry information

Official study title

Rapid Intravenous Infusion of 10 and 22 Degrees Celsius Ringer's Lactate in Healthy Volunteers and Its Effects on Circulation and Hemostasis - a Randomized Crossover Trial

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Oct 2, 2024
Registry last updated
Oct 8, 2024

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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