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

October 4, 2024 updated by: Esbjerg Hospital - University Hospital of Southern Denmark

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
25

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Odense, Denmark, 5000
        • Odense University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: 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)
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.
Active Comparator: 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)
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Increase in Mean Arterial Pressure (MAP) 30 minutes after started infusion
Time Frame: Trial day 1 & Trial day 2
Trial day 1 & Trial day 2

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time until return of Mean Arterial Pressure (MAP) to baseline value after infusion
Time Frame: Trial day 1 & Trial day 2
Trial day 1 & Trial day 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.
Trial day 1 & Trial day 2
Changes in physiological parameter temperature measured in degrees Celcius
Time Frame: Trial day 1 & Trial day 2
Trial day 1 & Trial day 2
Changes in physiological parameter blood pressure measured in millimeter of mercury (mmHg)
Time Frame: Trial day 1 & Trial day 2
Trial day 1 & Trial day 2
Changes in physiological parameter peripheral oxygen saturation measured in percent (%)
Time Frame: Trial day 1 & Trial day 2
Trial day 1 & Trial day 2
Changes in physiological parameter cardiac index measured in L/min/m2
Time Frame: Trial day 1 & Trial day 2
Trial day 1 & Trial day 2
Changes in physiological parameter cardias output measured in L/min
Time Frame: Trial day 1 & Trial day 2
Trial day 1 & Trial day 2
Changes in physiological parameter total peripheral resistance index measured in dyn·s/cm5
Time Frame: Trial day 1 & Trial day 2
Trial day 1 & Trial day 2
Changes in physiological parameter stroke volume measured in mL
Time Frame: Trial day 1 & Trial day 2
Trial day 1 & Trial day 2
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
Trial day 1 & Trial day 2
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
Trial day 1 & Trial day 2
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
Trial day 1 & Trial day 2
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
Trial day 1 & Trial day 2
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
Trial day 1 & Trial day 2
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
Trial day 1 & Trial day 2
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
Trial day 1 & Trial day 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Esbjerg Hospital - University Hospital of Southern Denmark

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Odense University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mikkel Brabrand, MD, Odense University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 6, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 20, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 20, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 17, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 30, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 2, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 8, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 4, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2023-506018-35-00

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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