Clinical trial NCT06622499: The Colder Fluids - Intravenous Infusion of 10 Degrees Celsius Fluids and Its Effects on Circulation and Hemostasis
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hemodynamic Instability
Lead sponsor: Esbjerg Hospital - University Hospital of Southern Denmark
Sponsor class: OTHER
Collaborators: name: Odense University Hospital
First posted: 2024-10-02
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: 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)

Primary outcomes:
measure: Increase in Mean Arterial Pressure (MAP) 30 minutes after started infusion
timeFrame: Trial day 1 & Trial day 2
Secondary outcomes:
measure: Time until return of Mean Arterial Pressure (MAP) to baseline value after infusion
timeFrame: Trial day 1 & Trial day 2
measure: Changes in Visual Analog Scale (VAS) of discomfort during infusion
timeFrame: Trial day 1 & Trial day 2
measure: Changes in physiological parameter temperature measured in degrees Celcius
timeFrame: Trial day 1 & Trial day 2
measure: Changes in physiological parameter blood pressure measured in millimeter of mercury (mmHg)
timeFrame: Trial day 1 & Trial day 2
measure: Changes in physiological parameter peripheral oxygen saturation measured in percent (%)
timeFrame: Trial day 1 & Trial day 2
measure: Changes in physiological parameter cardiac index measured in L/min/m2
timeFrame: Trial day 1 & Trial day 2
measure: Changes in physiological parameter cardias output measured in L/min
timeFrame: Trial day 1 & Trial day 2
measure: Changes in physiological parameter total peripheral resistance index measured in dyn·s/cm5
timeFrame: Trial day 1 & Trial day 2
measure: Changes in physiological parameter stroke volume measured in mL
timeFrame: Trial day 1 & Trial day 2
measure: Changes in physiological parameter intravascular volume status and fluid responsiveness measured in vena cava inferior maximum diameter and index via ultrasound
timeFrame: Trial day 1 & Trial day 2
measure: Changes in physiological parameter of INR blood test measured in prothrombin time at baseline, after 30 minutes and after 60 minutes
timeFrame: Trial day 1 & Trial day 2
measure: Changes in physiological parameter APTT blood test measured in seconds at baseline, after 30 minutes and after 60 minutes
timeFrame: Trial day 1 & Trial day 2
measure: Changes in physiological parameter Fibrinogen blood test measured in µmol/L at baseline, after 30 minutes and after 60 minutes
timeFrame: Trial day 1 & Trial day 2
measure: Changes in physiological parameter Platelet count blood test measured in 109/L at baseline, after 30 minutes and after 60 minutes
timeFrame: Trial day 1 & Trial day 2
measure: Changes in physiological parameter Flowcytometry blood tests (CD63, CD62p, PAC-1) measured in % at baseline, after 30 minutes and after 60 minutes
timeFrame: Trial day 1 & Trial day 2
measure: 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
timeFrame: Trial day 1 & Trial day 2
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Odense University Hospital
Study officials:
affiliation: Odense University Hospital
name: Mikkel Brabrand, MD
role: PRINCIPAL_INVESTIGATOR
References: