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

NCT06622499 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2024-10-08

No results posted yet for this study

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

Conditions

  • Hemodynamic Instability

Interventions

DRUG

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.

Sponsors & Collaborators

  • Odense University Hospital

    collaborator OTHER

  • Esbjerg Hospital - University Hospital of Southern Denmark

    lead OTHER

Principal Investigators

  • Mikkel Brabrand, MD · Odense University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-11-06
Primary Completion
2023-12-20
Completion
2023-12-20

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06622499 on ClinicalTrials.gov