Hemodynamic InstabilityPhase 1NCT06622499
The Colder Fluids - Intravenous Infusion of 10 Degrees Celsius Fluids and Its Effects on Circulation and Hemostasis
A Phase 1 study testing Ringer's Lactate in people with Hemodynamic Instability, run by Esbjerg Hospital - University Hospital of Southern Denmark at 1 site in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Hemodynamic Instability
- What is being tested?
- Ringer's Lactate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteDenmark
- Study dates
- 6 Nov 2023to 20 Dec 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 18-64
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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
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:
Read more
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
- Being tested
- Ringer's Lactate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ringer's LactateDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Cold - Room temperature | Active comparator | 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) Receives: Drug: Ringer's Lactate |
| Room temperature - Cold | Active comparator | 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) Receives: Drug: Ringer's Lactate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase in Mean Arterial Pressure (MAP) 30 minutes after started infusion
Measured: Trial day 1 & Trial day 2
Secondary outcomes (16)
Time until return of Mean Arterial Pressure (MAP) to baseline value after infusion
Measured: Trial day 1 & Trial day 2
Changes in Visual Analog Scale (VAS) of discomfort during infusion
Visual analoge scale of discomfort to assess participants discomfort during the trial. A scale labelled from 0=no discomfort to 10=maximum discomfort imaginable.
Measured: Trial day 1 & Trial day 2
Changes in physiological parameter temperature measured in degrees Celcius
Measured: Trial day 1 & Trial day 2
Changes in physiological parameter blood pressure measured in millimeter of mercury (mmHg)
Measured: Trial day 1 & Trial day 2
Changes in physiological parameter peripheral oxygen saturation measured in percent (%)
Measured: Trial day 1 & Trial day 2
Changes in physiological parameter cardiac index measured in L/min/m2
Measured: Trial day 1 & Trial day 2
Changes in physiological parameter cardias output measured in L/min
Measured: Trial day 1 & Trial day 2
Changes in physiological parameter total peripheral resistance index measured in dyn·s/cm5
Measured: Trial day 1 & Trial day 2
Changes in physiological parameter stroke volume measured in mL
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Trial day 1 & Trial day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2024
- Study start6 Nov 2023
- Primary completion20 Dec 2023
- Study completion20 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodynamic InstabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Esbjerg Hospital - University Hospital of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Odense University Hospital
- Responsible party
- Sponsor
- Investigators
- Mikkel Brabrand, MD, Principal investigator, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06622499
- Sponsor's protocol ID
- 2023-506018-35-00
- Other IDs
- 2023
- Status last verified
- Oct 2024
- First submitted
- 17 Jun 2024
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06622499
- Acronym / sponsor ID
- 2023-506018-35-00
- Conditions
- Hemodynamic Instability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Esbjerg Hospital - University Hospital of Southern DenmarkUniversity, hospital or other
- Collaborators
- Odense University Hospital
- Study start
- 6 Nov 2023 (actual)
- Primary completion
- 20 Dec 2023 (actual)
- Study completion
- 20 Dec 2023 (actual)
- First posted
- 2 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cold - Room temperature | Active comparator | Drug: Ringer's LactateTrial 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) |
| Room temperature - Cold | Active comparator | Drug: Ringer's LactateTrial 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) |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Age between 18-64
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ringer's LactateOn 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. | Drug | Cold - Room temperature, Room temperature - Cold |
Primary outcome
Increase in Mean Arterial Pressure (MAP) 30 minutes after started infusion
Time frame: Trial day 1 & Trial day 2
16 secondary outcomes
Time until return of Mean Arterial Pressure (MAP) to baseline value after infusion
Time frame: Trial day 1 & Trial day 2
Changes in Visual Analog Scale (VAS) of discomfort during infusion
Time frame: Trial day 1 & Trial day 2
Changes in physiological parameter temperature measured in degrees Celcius
Time frame: 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
Changes in physiological parameter peripheral oxygen saturation measured in percent (%)
Time frame: 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
Changes in physiological parameter cardias output measured in L/min
Time frame: 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
Changes in physiological parameter stroke volume measured in mL
Time frame: 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
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mikkel Brabrand, MD principal investigator
Odense University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ringer's Lactate in people with Hemodynamic Instability, run by Esbjerg Hospital - University Hospital of Southern Denmark at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increase in Mean Arterial Pressure (MAP) 30 minutes after started infusion (time frame: Trial day 1 & Trial day 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2024.