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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.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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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
Show all 12Show fewer
  • 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

Other trials in Sweden

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.

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 groups in NCT04576806
Study groupRoleWhat they receive
Body temperature fluid bolus of crystalloidActive comparatorFluid bolus at 38 degrees celsius of 500ml crystalloid over 15 minutes
Receives: Other: Body temperature; Drug: Fluid bolus
Room temperature fluid bolus of crystalloidExperimentalFluid 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.

  1. MAP

    Mean arterial pressure

    Measured: 15 minutes

Secondary outcomes (45)

  1. MAP

    Systolic blood pressure

    Measured: 1 hour

  2. MAP

    Systolic blood pressure

    Measured: 2 hours

  3. SBP

    Systolic blood pressure

    Measured: 15 minutes

  4. SBP

    Systolic blood pressure

    Measured: 1 hour

  5. SBP

    Systolic blood pressure

    Measured: 2 hours

  6. DBP

    Diastolic blood pressure

    Measured: 15 minutes

  7. DBP

    Diastolic blood pressure

    Measured: 1 hour

  8. DBP

    Diastolic blood pressure

    Measured: 2 hours

  9. HR

    Heart rate

    Measured: 15 minutes

  10. HR

    Heart rate

    Measured: 1 hour

  11. HR

    Heart rate

    Measured: 2 hours

  12. CO

    Cardiac output

    Measured: 15 minutes

  13. CO

    Cardiac output

    Measured: 1 hour

  14. CO

    Cardiac output

    Measured: 2 hours

  15. CI

    Cardiac index

    Measured: 15 minutes

  16. CI

    Cardiac index

    Measured: 1 hour

  17. CI

    Cardiac index

    Measured: 2 hours

  18. SV

    Stroke volume

    Measured: 15 minutes

  19. SV

    Stroke volume

    Measured: 1 hour

  20. SV

    Stroke volume

    Measured: 2 hours

  21. SVV

    Stroke volume variation

    Measured: 15 minutes

  22. SVV

    Stroke volume variation

    Measured: 1 hour

  23. SVV

    Stroke volume variation

    Measured: 2 hours

  24. EVLW

    Extra vascular lung water

    Measured: 15 minutes

  25. EVLW

    Extra vascular lung water

    Measured: 1 hour

  26. EVLW

    Extra vascular lung water

    Measured: 2 hours

  27. Type ofh eart rhythm

    Heart rhythm

    Measured: 15 minutes

  28. Type of heart rhythm

    Heart rhythm

    Measured: 1 hour

  29. Type of heart rhythm

    Heart rhythm

    Measured: 2 hours

  30. Levels of administered vasopressors

    Amount of pressors

    Measured: 15 minutes

  31. Levels of administered vasopressors

    Amount of pressors

    Measured: 1 hours

  32. Levels of administered vasopressors

    Amount of pressors

    Measured: 2 hours

  33. Levels of administered sedating medications

    Amount of sedation

    Measured: 15 minutes

  34. Levels of administered sedating medications

    Amount of sedation

    Measured: 1 hours

  35. Levels of administered sedating medications

    Amount of sedation

    Measured: 2 hours

  36. Lactate

    Lactate

    Measured: 15 minutes

  37. Levels of lactate

    Lactate

    Measured: 1 hour

  38. Levels of lactate

    Lactate

    Measured: 2 hours

  39. Hourly urine output

    Urine output

    Measured: 1 hour

  40. Hourly urine output

    Urine output

    Measured: 2 hours

  41. Temperature change

    Temperature change

    Measured: 15 minutes

  42. Temperature change

    Temperature change

    Measured: 1 hour

  43. Temperature change

    Temperature change

    Measured: 2 hours

  44. Daily fluid balance

    Fluid balance

    Measured: 24 hours

  45. 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.

  1. First posted6 Oct 2020
  2. Study start30 Apr 2021 (estimated)
  3. Primary completion30 Oct 2021 (estimated)
  4. Study completion30 Oct 2021 (estimated)

Why it stopped: Other research priorities during Covid-19 pandemic.

Resources

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)
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

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?

On the ClinicalTrials.gov record for NCT04576806.

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.

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