Temperature Change, BodyNCT03209271
Hemodynamic Effects of Cold Versus Warm Fluid Bolus
A study testing Ringer's Acetate (warm) and Ringer's Acetate (cold) in people with Temperature Change, Body and Hypovolemia, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
Fluid boluses are often administered with the aim of improving tissue perfusion in critically ill patients. It is unclear whether the temperature of the fluid has an impact on the hemodynamic response. The aim of this study is to describe the hemodynamic effects of a fluid bolus with two different temperatures. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Temperature Change, Body, Hypovolemia
- What is being tested?
- Ringer's Acetate (warm) and Ringer's Acetate (cold)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteSweden
- Study dates
- 3 Feb 2017to 27 May 2017
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Volunteers 18 years or older Previously healthy
Who cannot join
- American Society of Anesthesiologists classification 2 or above.
- Known pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hemodynamic Effects of Cold Versus Warm Fluid Bolus Infusion in Healthy Volunteers: a Randomized Cross-over Trial
Fluid boluses are often administered with the aim of improving tissue perfusion in critically ill patients. It is unclear whether the temperature of the fluid has an impact on the hemodynamic response. The aim of this study is to describe the hemodynamic effects of a fluid bolus with two different temperatures.
Read the detailed description
A randomized, controlled, cross-over study in 21 healthy volunteers. The participants will receive a fluid bolus of 500 ml Ringer's Acetate at either 22°C or 38°C over 15 minutes in a randomized order. Non-invasive measures will be made of cardiac index, mean arterial pressure, systolic blood pressure, diastolic blood pressure, heart and pulse rate, saturation and temperature. Hemodynamic measure will be made using the Clearsight® system. Measurements will be made during 120 minutes. The second session will take place at least one day later, and the participant will then receive the other fluid temperature.
- Conditions
- Temperature Change, Body, Hypovolemia
- Being tested
- Ringer's Acetate (warm), Ringer's Acetate (cold)
- Keywords
- Fluid therapy
- Medical subject headings
- Body Temperature Changes, Hypovolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ringer's Acetate (warm)Drug
Also called Ringer-Acetat Baxter Viaflo, ATC B05BB01
Body temperature fluid
Ringer's Acetate (cold)Drug
Also called Ringer-Acetat Baxter Viaflo, ATC B05BB01
Room temperature fluid
| Study group | Role | What they receive |
|---|---|---|
| Body temperature fluid | Experimental | 500ml Ringers Acetate infused over 15 minutes warmed to 38°C Receives: Drug: Ringer's Acetate (warm) |
| Room temperature fluid | Active comparator | 500ml Ringers Acetate infused over 15 minutes cooled to 22°C Receives: Drug: Ringer's Acetate (cold) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac index 15 minutes
Change in cardiac index at 15 minutes from start of infusion
Measured: 15 minutes
Secondary outcomes (4)
Cardiac index 120 minutes
Change in cardiac index during 120 minutes from start of infusion
Measured: 120 minutes
Blood pressure 120 minutes
Change in blood pressure during 120 minutes from start of infusion
Measured: 120 minutes
Heart rate 120 minutes
Change in heart rate during 120 minutes from start of infusion
Measured: 120 minutes
Temperature 120 minutes
Change in body temperature during 120 minutes from start of infusion
Measured: 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2017
- Study start3 Feb 2017
- Primary completion27 May 2017
- Study completion27 May 2017
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 Temperature Change, BodyStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Crossover study of 2 different temperatures of crystalloid fluid bolus.
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christer Svensen, Karolinska Institutet
- Investigators
- Maria Cronhjort, MD, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03209271
- Sponsor's protocol ID
- EPN 2016/986-31/1
- Status last verified
- Jul 2017
- First submitted
- 26 Jun 2017
- Last updated
- 6 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wall O, Ehrenberg L, Joelsson-Alm E, Martensson J, Bellomo R, Svensen C, Cronhjort M. Haemodynamic effects of cold versus warm fluid bolus in healthy volunteers: a randomised crossover trial. Crit Care Resusc. 2018 Dec;20(4):277-284.
PubMed 30482135
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic Effects of Cold Versus Warm Fluid Bolus Infusion in Healthy Volunteers: a Randomized Cross-over Trial
- ClinicalTrials.gov ID
- NCT03209271
- Acronym / sponsor ID
- EPN 2016/986-31/1
- Conditions
- Temperature Change, Body, Hypovolemia
- Keywords
- Fluid therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 3 Feb 2017 (actual)
- Primary completion
- 27 May 2017 (actual)
- Study completion
- 27 May 2017 (actual)
- First posted
- 6 Jul 2017 (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.
Fluid boluses are often administered with the aim of improving tissue perfusion in critically ill patients. It is unclear whether the temperature of the fluid has an impact on the hemodynamic response. The aim of this study is to describe the hemodynamic effects of a fluid bolus with two different temperatures.
Detailed description
A randomized, controlled, cross-over study in 21 healthy volunteers. The participants will receive a fluid bolus of 500 ml Ringer's Acetate at either 22°C or 38°C over 15 minutes in a randomized order. Non-invasive measures will be made of cardiac index, mean arterial pressure, systolic blood pressure, diastolic blood pressure, heart and pulse rate, saturation and temperature. Hemodynamic measure will be made using the Clearsight® system. Measurements will be made during 120 minutes. The second session will take place at least one day later, and the participant will then receive the other fluid temperature.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Crossover study of 2 different temperatures of crystalloid fluid bolus.
| Arm | Type | Receives |
|---|---|---|
| Body temperature fluid | Experimental | Drug: Ringer's Acetate (warm)500ml Ringers Acetate infused over 15 minutes warmed to 38°C |
| Room temperature fluid | Active comparator | Drug: Ringer's Acetate (cold)500ml Ringers Acetate infused over 15 minutes cooled to 22°C |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Volunteers 18 years or older Previously healthy
Key exclusion criteria (2 listed)
- American Society of Anesthesiologists classification 2 or above.
- Known pregnancy
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 Acetate (warm)Also: Ringer-Acetat Baxter Viaflo, ATC B05BB01Body temperature fluid | Drug | Body temperature fluid |
| Ringer's Acetate (cold)Also: Ringer-Acetat Baxter Viaflo, ATC B05BB01Room temperature fluid | Drug | Room temperature fluid |
Primary outcome
Cardiac index 15 minutes
Time frame: 15 minutes
Change in cardiac index at 15 minutes from start of infusion
4 secondary outcomes
Cardiac index 120 minutes
Time frame: 120 minutes
Blood pressure 120 minutes
Time frame: 120 minutes
Heart rate 120 minutes
Time frame: 120 minutes
Temperature 120 minutes
Time frame: 120 minutes
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 6 Jul 2017.
- Derived from this study: PubMed 30482135Wall O, Ehrenberg L, Joelsson-Alm E, Martensson J, Bellomo R, Svensen C, Cronhjort M. Haemodynamic effects of cold versus warm fluid bolus in healthy volunteers: a randomised crossover trial. Crit Care Resusc. 2018 Dec;20(4):277-284.
- 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.
Maria Cronhjort, MD, PhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ringer's Acetate (warm) and Ringer's Acetate (cold) in people with Temperature Change, Body and Hypovolemia, run by Karolinska Institutet at 1 site in Sweden.
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 2 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 6 Jul 2017. 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 Sweden. 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.
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?
Cardiac index 15 minutes (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 NCT03209271, 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 6 Jul 2017.