Hemodynamic InstabilityPhase 4NCT05610254
The Cold Fluids Study
A Phase 4 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
In this single center crossover study the aim is to investigate the effect of Ringer's lactate solution at high and low temperatures on physiological response in healthy adults.18 healthy volunteers will be included. Inclusion criteria is; Age between 18-64. 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
- 18 participants
- Where
- 1 siteDenmark
- Study dates
- 24 Oct 2022to 3 Dec 2022
- Phase
- Phase 4
- 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
- Pregnancy (validated through a certified pregnancy test)
- Body mass index >35 kg/m2
- Medication use apart from allergy medication, contraceptives, or non-steroidal anti-inflammatory drugs.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Rapid Infusion of Ringer's Lactate Solution At Different Temperatures and the Effects on Circulation and Perfusion in Healthy Volunteers - a Randomized Crossover Trial
In this single center crossover study the aim is to investigate the effect of Ringer's lactate solution at high and low temperatures on physiological response in healthy adults.18 healthy volunteers will be included. Inclusion criteria is; Age between 18-64. Exclusion criteria is; Pre-existing medical problems, Pregnancy (validated through a certified pregnancy test), Body mass index >35 kg/m2, Medication use apart from allergy medication, contraceptives, or non-steroidal anti-inflammatory drugs.
Participants will be randomized to receive 30 ml/kg of Ringer's lactate either cold (15°C, 59°F), or at body temperature (37°C, 98.6°F) during a 30-minute interval. 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.
Read more
Primary outcome is
- The increase in MAP at 15 minutes after infusion of the fluid bolus. Secondary outcome is
- Time until return of MAP to baseline value after infusion.
- 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 30 ml/kg of Ringer's lactate either cold (15°C, 59°F), or at body temperature (37°C, 98.6°F) during a 30-minute interval. 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-Warm | Active comparator | Trial day 1: Participants receive Ringer's lactate cold (15°C, 59°F), Trial day 2: Participants receive Ringer's lactate at body temperature (37°C, 98.6°F) Receives: Drug: Ringer's Lactate |
| Warm-Cold | Active comparator | Trial day 1: Participants receive Ringer's lactate at body temperature (37°C, 98.6°F) Trial day 2: Participants receive Ringer's lactate cold (15°C, 59°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 MAP at 15 minutes after infusion of the fluid bolus.
Measured: 15 minutes
Secondary outcomes (1)
Time until return of MAP to baseline value after infusion.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2022
- Study start24 Oct 2022
- Primary completion3 Dec 2022
- Study completion3 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Esbjerg Hospital - University Hospital of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Odense University Hospital, University of Southern Denmark, Simon Fougner Hartmanns Family Foundation, Department of Clinical Biochemistry, Vejle Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05610254
- Sponsor's protocol ID
- 2022-002137-34
- Status last verified
- Sep 2024
- First submitted
- 2 Nov 2022
- Last updated
- 5 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Biesenbach P, Molmer MB, Svendsen EL, Teichmann D, Wuthe S, Momeni M, Kristensen MR, Laugesen LE, Berg-Beckhoff G, Bentsen LP, Bergmann ML, Brabrand M. Ringer's lactate administered at 15 degrees C leads to a greater and more prolonged increase in blood pressure compared to 37 degrees C. Sci Rep. 2024 Oct 26;14(1):25592. doi: 10.1038/s41598-024-76858-0.
PubMed 39462030
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapid Infusion of Ringer's Lactate Solution At Different Temperatures and the Effects on Circulation and Perfusion in Healthy Volunteers - a Randomized Crossover Trial
- ClinicalTrials.gov ID
- NCT05610254
- Acronym / sponsor ID
- 2022-002137-34
- Conditions
- Hemodynamic Instability
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Esbjerg Hospital - University Hospital of Southern DenmarkUniversity, hospital or other
- Collaborators
- Odense University Hospital, University of Southern Denmark, Simon Fougner Hartmanns Family Foundation, Department of Clinical Biochemistry, Vejle Hospital
- Study start
- 24 Oct 2022 (actual)
- Primary completion
- 3 Dec 2022 (actual)
- Study completion
- 3 Dec 2022 (actual)
- First posted
- 9 Nov 2022 (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.
In this single center crossover study the aim is to investigate the effect of Ringer's lactate solution at high and low temperatures on physiological response in healthy adults.18 healthy volunteers will be included. Inclusion criteria is; Age between 18-64. Exclusion criteria is; Pre-existing medical problems, Pregnancy (validated through a certified pregnancy test), Body mass index >35 kg/m2, Medication use apart from allergy medication, contraceptives, or non-steroidal anti-inflammatory drugs.
Participants will be randomized to receive 30 ml/kg of Ringer's lactate either cold (15°C, 59°F), or at body temperature (37°C, 98.6°F) during a 30-minute interval. 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.
Primary outcome is
- The increase in MAP at 15 minutes after infusion of the fluid bolus. Secondary outcome is
- Time until return of MAP to baseline value after infusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cold-Warm | Active comparator | Drug: Ringer's LactateTrial day 1: Participants receive Ringer's lactate cold (15°C, 59°F), Trial day 2: Participants receive Ringer's lactate at body temperature (37°C, 98.6°F) |
| Warm-Cold | Active comparator | Drug: Ringer's LactateTrial day 1: Participants receive Ringer's lactate at body temperature (37°C, 98.6°F) Trial day 2: Participants receive Ringer's lactate cold (15°C, 59°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 (4 listed)
- Pre-existing medical problems
- Pregnancy (validated through a certified pregnancy test)
- Body mass index >35 kg/m2
- Medication use apart from allergy medication, contraceptives, or non-steroidal anti-inflammatory drugs.
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 30 ml/kg of Ringer's lactate either cold (15°C, 59°F), or at body temperature (37°C, 98.6°F) during a 30-minute interval. After a minimum "washout period" of 24 hours, subjects are switched to receive infusion at the other aforementioned temperatures. | Drug | Cold-Warm, Warm-Cold |
Primary outcome
Increase in MAP at 15 minutes after infusion of the fluid bolus.
Time frame: 15 minutes
1 secondary outcome
Time until return of MAP to baseline value after infusion.
Time frame: 2 hours
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 5 Sep 2024.
- Derived from this study: PubMed 39462030Biesenbach P, Molmer MB, Svendsen EL, Teichmann D, Wuthe S, Momeni M, Kristensen MR, Laugesen LE, Berg-Beckhoff G, Bentsen LP, Bergmann ML, Brabrand M. Ringer's lactate administered at 15 degrees C leads to a greater and more prolonged increase in blood pressure compared to 37 degrees C. Sci Rep. 2024 Oct 26;14(1):25592. doi: 10.1038/s41598-024-76858-0.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 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 4 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 5 Sep 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 MAP at 15 minutes after infusion of the fluid bolus. (time frame: 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05610254, which also lists 1 linked publication.
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 5 Sep 2024.