Critical IllnessNCT04576806
Physiological Effects of 38°C vs. 22°C Fluid Therapy in Critically Ill Patients
A study testing Body temperature, Fluid bolus and Room temperature in people with Critical Illness and Sepsis, run by Karolinska Institutet at 2 sites in Sweden.
Trial summary
A randomized controlled clinical trial. 24 adult ICU patients will be recruited upon decision to administer fluid bolus of 500ml of crystalloid. The fluid will then be randomized to be infused at controlled room temperature or warmed to body temperature. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Sepsis, Fluid Overload
- What is being tested?
- Body temperature, Fluid bolus and Room temperature
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesSweden
- Study dates
- 30 Apr 2021to 30 Oct 2021
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Admission to the ICU
- Age 18 years or older
- Clinical decision to administer a fluid bolus of at least 500 ml of crystalloid over 15 minutes.
- Monitoring with either an arterial line in an extremity that can be used for pulse contour analysis (Vigileo, FloTrac or equivalent system) or a central venous catheter and a femoral arterial line that can be used for pulse contour analysis calibrated by thermodilution (EV1000, PiCCO or equivalent system)
- At least one of the following criteria for fluid administration must be met:
- MAP < 65 mmHg
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- HR >100
- Urine output < 0,5ml/kg/h
- Lactate levels of > 3 mmol/l
- CI < 2.5L/min/m2
- SVV or PPV > 12% if mechanically ventilated with tidal volumes > 7 ml/kg
- ScvO2 or SvO2 < 65%
Who cannot join
- Active bleeding requiring transfusion
- Haemoglobin level <70 g/L
- Arrhythmia disturbing monitoring of cardiac output
- Patients in whom death is considered imminent (within 24 hours)
- CRRT
- Known pregnancy
Show all 9Show fewer
- Active temperature control, either active warming or cooling
- Medical issue of pathological thermoregulation, such as malignant hyperthermia, thyroid storm, NMDA overdose, serotonin syndrome, malignant neuroleptic syndrome, or delirium.
- Planned exit from the ICU during the 2-hour monitoring period (planned surgical procedure, radiology, change of department etc.)
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Södersjukhuset
Stockholm, 118 83
Danderyds sjukhus
Stockholm, 182 57
About this study
Official title: Physiological Effects of 38°C vs. 22°C Fluid Therapy in Critically Ill Patients: A Randomized Controlled ICU Study
A randomized controlled clinical trial. 24 adult ICU patients will be recruited upon decision to administer fluid bolus of 500ml of crystalloid. The fluid will then be randomized to be infused at controlled room temperature or warmed to body temperature. Hemodynamic measurements will be made for 2 hours following the bolus, and laboratory values will be noted. The hypothesis is that part of the hemodynamic response will differed in response to cooling, and be larger in the cold group.
Read the detailed description
A randomized controlled clinical trial of the influence of fluid temperature on hemodynamic effects of fluids. 24 adult ICU patients meeting objective criteria of circulatory impairment (hypotension, tachycardia, lactatemia etc) will be recruited upon decision to administer fluid bolus of 500ml of crystalloid. The fluid will then be randomized to be infused at controlled room temperature of 22 degrees or warmed to body temperature at 38 degrees. All patients will be monitored with either calibrated or uncalibrated pulse contour analysis. Hemodynamic measurements (Heart rate (HR), Systolic blood pressure (SBP), Diastolic blood pressure (DBP), Mean arterial pressure (MAP), Cardiac output (CO), Cardiac index (CI), Stroke volume (SV), Stroke volume variation (SVV), Extravascular lung water (EVLW) etc) will be registered for 2 hours following the bolus, and laboratory values such as lactate, creatinine will be noted, as well as fluid balances. Confounders such as levels of vasopressors, sedation, switches in positioning och or ventilation will be registered. The hypothesis is that part of the hemodynamic response will differed in response to cooling, and be larger in the cold group.
- Conditions
- Critical Illness, Sepsis, Fluid Overload, Hemodynamic Instability
- Being tested
- Body temperature, Fluid bolus, Room temperature
- Keywords
- Fluid therapy, Bolus
- Medical subject headings
- Critical Illness, Sepsis, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Body temperatureOther
Warming of administered fluid bolus
Fluid bolusDrug
Administration of fluid bolus of crystalloid of 500ml over 15 minutes
Room temperatureOther
Cooling of administered fluid bolus
| Study group | Role | What they receive |
|---|---|---|
| Body temperature fluid bolus of crystalloid | Active comparator | Fluid bolus at 38 degrees celsius of 500ml crystalloid over 15 minutes Receives: Other: Body temperature; Drug: Fluid bolus |
| Room temperature fluid bolus of crystalloid | Experimental | Fluid bolus at 22 degrees celsius of 500ml crystalloid over 15 minutes Receives: Drug: Fluid bolus; Other: Room temperature |
What is being measured
The primary outcome is the main question the study is designed to answer.
MAP
Mean arterial pressure
Measured: 15 minutes
Secondary outcomes (45)
MAP
Systolic blood pressure
Measured: 1 hour
MAP
Systolic blood pressure
Measured: 2 hours
SBP
Systolic blood pressure
Measured: 15 minutes
SBP
Systolic blood pressure
Measured: 1 hour
SBP
Systolic blood pressure
Measured: 2 hours
DBP
Diastolic blood pressure
Measured: 15 minutes
DBP
Diastolic blood pressure
Measured: 1 hour
DBP
Diastolic blood pressure
Measured: 2 hours
HR
Heart rate
Measured: 15 minutes
HR
Heart rate
Measured: 1 hour
HR
Heart rate
Measured: 2 hours
CO
Cardiac output
Measured: 15 minutes
CO
Cardiac output
Measured: 1 hour
CO
Cardiac output
Measured: 2 hours
CI
Cardiac index
Measured: 15 minutes
CI
Cardiac index
Measured: 1 hour
CI
Cardiac index
Measured: 2 hours
SV
Stroke volume
Measured: 15 minutes
SV
Stroke volume
Measured: 1 hour
SV
Stroke volume
Measured: 2 hours
SVV
Stroke volume variation
Measured: 15 minutes
SVV
Stroke volume variation
Measured: 1 hour
SVV
Stroke volume variation
Measured: 2 hours
EVLW
Extra vascular lung water
Measured: 15 minutes
EVLW
Extra vascular lung water
Measured: 1 hour
EVLW
Extra vascular lung water
Measured: 2 hours
Type ofh eart rhythm
Heart rhythm
Measured: 15 minutes
Type of heart rhythm
Heart rhythm
Measured: 1 hour
Type of heart rhythm
Heart rhythm
Measured: 2 hours
Levels of administered vasopressors
Amount of pressors
Measured: 15 minutes
Levels of administered vasopressors
Amount of pressors
Measured: 1 hours
Levels of administered vasopressors
Amount of pressors
Measured: 2 hours
Levels of administered sedating medications
Amount of sedation
Measured: 15 minutes
Levels of administered sedating medications
Amount of sedation
Measured: 1 hours
Levels of administered sedating medications
Amount of sedation
Measured: 2 hours
Lactate
Lactate
Measured: 15 minutes
Levels of lactate
Lactate
Measured: 1 hour
Levels of lactate
Lactate
Measured: 2 hours
Hourly urine output
Urine output
Measured: 1 hour
Hourly urine output
Urine output
Measured: 2 hours
Temperature change
Temperature change
Measured: 15 minutes
Temperature change
Temperature change
Measured: 1 hour
Temperature change
Temperature change
Measured: 2 hours
Daily fluid balance
Fluid balance
Measured: 24 hours
Daily fluid balance
Fluid balance
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2020
- Study start30 Apr 2021 (estimated)
- Primary completion30 Oct 2021 (estimated)
- Study completion30 Oct 2021 (estimated)
Why it stopped: Other research priorities during Covid-19 pandemic.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- RCT, unblinded
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Danderyd Hospital, Stockholm South General Hospital
- Responsible party
- Principal investigator, Christer Svensen, Karolinska Institutet
- Investigators
- Maria Cronhjort, MD, PhD, Study director, maria.cronhjort@ki.se
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04576806
- Sponsor's protocol ID
- EPN 2019-05492
- Status last verified
- Mar 2023
- First submitted
- 23 Feb 2020
- Last updated
- 10 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No data will be shared outside the research group
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiological Effects of 38°C vs. 22°C Fluid Therapy in Critically Ill Patients: A Randomized Controlled ICU Study
- ClinicalTrials.gov ID
- NCT04576806
- Acronym / sponsor ID
- EPN 2019-05492
- Conditions
- Critical Illness, Sepsis, Fluid Overload, Hemodynamic Instability
- Keywords
- Fluid therapy, Bolus
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Other research priorities during Covid-19 pandemic.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Danderyd Hospital, Stockholm South General Hospital
- Study start
- 30 Apr 2021 (estimated)
- Primary completion
- 30 Oct 2021 (estimated)
- Study completion
- 30 Oct 2021 (estimated)
- First posted
- 6 Oct 2020 (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.
A randomized controlled clinical trial. 24 adult ICU patients will be recruited upon decision to administer fluid bolus of 500ml of crystalloid. The fluid will then be randomized to be infused at controlled room temperature or warmed to body temperature. Hemodynamic measurements will be made for 2 hours following the bolus, and laboratory values will be noted. The hypothesis is that part of the hemodynamic response will differed in response to cooling, and be larger in the cold group.
Detailed description
A randomized controlled clinical trial of the influence of fluid temperature on hemodynamic effects of fluids. 24 adult ICU patients meeting objective criteria of circulatory impairment (hypotension, tachycardia, lactatemia etc) will be recruited upon decision to administer fluid bolus of 500ml of crystalloid. The fluid will then be randomized to be infused at controlled room temperature of 22 degrees or warmed to body temperature at 38 degrees. All patients will be monitored with either calibrated or uncalibrated pulse contour analysis. Hemodynamic measurements (Heart rate (HR), Systolic blood pressure (SBP), Diastolic blood pressure (DBP), Mean arterial pressure (MAP), Cardiac output (CO), Cardiac index (CI), Stroke volume (SV), Stroke volume variation (SVV), Extravascular lung water (EVLW) etc) will be registered for 2 hours following the bolus, and laboratory values such as lactate, creatinine will be noted, as well as fluid balances. Confounders such as levels of vasopressors, sedation, switches in positioning och or ventilation will be registered. The hypothesis is that part of the hemodynamic response will differed in response to cooling, and be larger in the cold group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- RCT, unblinded
| Arm | Type | Receives |
|---|---|---|
| Body temperature fluid bolus of crystalloid | Active comparator | Other: Body temperature, Drug: Fluid bolusFluid bolus at 38 degrees celsius of 500ml crystalloid over 15 minutes |
| Room temperature fluid bolus of crystalloid | Experimental | Drug: Fluid bolus, Other: Room temperatureFluid bolus at 22 degrees celsius of 500ml crystalloid over 15 minutes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Admission to the ICU
- Age 18 years or older
- Clinical decision to administer a fluid bolus of at least 500 ml of crystalloid over 15 minutes.
- Monitoring with either an arterial line in an extremity that can be used for pulse contour analysis (Vigileo, FloTrac or equivalent system) or a central venous catheter and a femoral arterial line that can be used for pulse contour analysis calibrated by thermodilution (EV1000, PiCCO or equivalent system)
- At least one of the following criteria for fluid administration must be met:
Key exclusion criteria (9 listed)
- Active bleeding requiring transfusion
- Haemoglobin level <70 g/L
- Arrhythmia disturbing monitoring of cardiac output
- Patients in whom death is considered imminent (within 24 hours)
- CRRT
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 |
|---|---|---|
| Body temperatureWarming of administered fluid bolus | Other | Body temperature fluid bolus of crystalloid |
| Fluid bolusAdministration of fluid bolus of crystalloid of 500ml over 15 minutes | Drug | Body temperature fluid bolus of crystalloid, Room temperature fluid bolus of crystalloid |
| Room temperatureCooling of administered fluid bolus | Other | Room temperature fluid bolus of crystalloid |
Primary outcome
MAP
Time frame: 15 minutes
Mean arterial pressure
45 secondary outcomes
MAP
Time frame: 1 hour
MAP
Time frame: 2 hours
SBP
Time frame: 15 minutes
SBP
Time frame: 1 hour
SBP
Time frame: 2 hours
DBP
Time frame: 15 minutes
DBP
Time frame: 1 hour
DBP
Time frame: 2 hours
HR
Time frame: 15 minutes
HR
Time frame: 1 hour
HR
Time frame: 2 hours
CO
Time frame: 15 minutes
CO
Time frame: 1 hour
CO
Time frame: 2 hours
CI
Time frame: 15 minutes
CI
Time frame: 1 hour
CI
Time frame: 2 hours
SV
Time frame: 15 minutes
SV
Time frame: 1 hour
SV
Time frame: 2 hours
SVV
Time frame: 15 minutes
SVV
Time frame: 1 hour
SVV
Time frame: 2 hours
EVLW
Time frame: 15 minutes
EVLW
Time frame: 1 hour
EVLW
Time frame: 2 hours
Type ofh eart rhythm
Time frame: 15 minutes
Type of heart rhythm
Time frame: 1 hour
Type of heart rhythm
Time frame: 2 hours
Levels of administered vasopressors
Time frame: 15 minutes
Levels of administered vasopressors
Time frame: 1 hours
Levels of administered vasopressors
Time frame: 2 hours
Levels of administered sedating medications
Time frame: 15 minutes
Levels of administered sedating medications
Time frame: 1 hours
Levels of administered sedating medications
Time frame: 2 hours
Lactate
Time frame: 15 minutes
Levels of lactate
Time frame: 1 hour
Levels of lactate
Time frame: 2 hours
Hourly urine output
Time frame: 1 hour
Hourly urine output
Time frame: 2 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2023.
- Individual participant dataSharing planned: No. No data will be shared outside the research group
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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 study director
maria.cronhjort@ki.se
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Body temperature, Fluid bolus and Room temperature in people with Critical Illness and Sepsis, run by Karolinska Institutet at 2 sites 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 12 inclusion and 9 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: withdrawn, as of the sponsor's last update on 10 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 was withdrawn before enrolling participants, so there are no results.
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?
MAP (time frame: 15 minutes). 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 10 Mar 2023.