The Colder Fluids - Intravenous Infusion of 10 Degrees Celsius Fluids and Its Effects on Circulation and Hemostasis
NCT ID: NCT06622499
Last Updated: 2024-10-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
25 participants
INTERVENTIONAL
2023-11-06
2023-12-20
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Cold - Room temperature
Trial day 1: Participants receive Ringer's lactate cold (10°C, 50°F), Trial day 2: Participants receive Ringer's lactate at room temperature (22°C, 71.6°F)
Ringer's Lactate
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.
Room temperature - Cold
Trial day 1: Participants receive Ringer's lactate at room temperature (22°C, 71.6°F), Trial day 2: Participants receive Ringer's lactate cold (10°C, 50°F)
Ringer's Lactate
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.
Interventions
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Ringer's Lactate
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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)
18 Years
64 Years
ALL
Yes
Sponsors
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Odense University Hospital
OTHER
Esbjerg Hospital - University Hospital of Southern Denmark
OTHER
Responsible Party
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Principal Investigators
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Mikkel Brabrand, MD
Role: PRINCIPAL_INVESTIGATOR
Odense University Hospital
Locations
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Odense University Hospital
Odense, , Denmark
Countries
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Other Identifiers
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2023-506018-35-00
Identifier Type: -
Identifier Source: org_study_id
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