Clinical trial NCT04576806: Physiological Effects of 38°C vs. 22°C Fluid Therapy in Critically Ill Patients
Official title: Physiological Effects of 38°C vs. 22°C Fluid Therapy in Critically Ill Patients: A Randomized Controlled ICU Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Critical Illness
Sepsis
Fluid Overload
Hemodynamic Instability
Keywords: Fluid therapy
Bolus
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Danderyd Hospital
name: Stockholm South General Hospital
First posted: 2020-10-06
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: RCT, unblinded
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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
* 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%

Exclusion Criteria:

* 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
* 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.)

Primary outcomes:
measure: MAP
timeFrame: 15 minutes
Secondary outcomes:
measure: MAP
timeFrame: 1 hour
measure: MAP
timeFrame: 2 hours
measure: SBP
timeFrame: 15 minutes
measure: SBP
timeFrame: 1 hour
measure: SBP
timeFrame: 2 hours
measure: DBP
timeFrame: 15 minutes
measure: DBP
timeFrame: 1 hour
measure: DBP
timeFrame: 2 hours
measure: HR
timeFrame: 15 minutes
measure: HR
timeFrame: 1 hour
measure: HR
timeFrame: 2 hours
measure: CO
timeFrame: 15 minutes
measure: CO
timeFrame: 1 hour
measure: CO
timeFrame: 2 hours
measure: CI
timeFrame: 15 minutes
measure: CI
timeFrame: 1 hour
measure: CI
timeFrame: 2 hours
measure: SV
timeFrame: 15 minutes
measure: SV
timeFrame: 1 hour
measure: SV
timeFrame: 2 hours
measure: SVV
timeFrame: 15 minutes
measure: SVV
timeFrame: 1 hour
measure: SVV
timeFrame: 2 hours
measure: EVLW
timeFrame: 15 minutes
measure: EVLW
timeFrame: 1 hour
measure: EVLW
timeFrame: 2 hours
measure: Type ofh eart rhythm
timeFrame: 15 minutes
measure: Type of heart rhythm
timeFrame: 1 hour
measure: Type of heart rhythm
timeFrame: 2 hours
measure: Levels of administered vasopressors
timeFrame: 15 minutes
measure: Levels of administered vasopressors
timeFrame: 1 hours
measure: Levels of administered vasopressors
timeFrame: 2 hours
measure: Levels of administered sedating medications
timeFrame: 15 minutes
measure: Levels of administered sedating medications
timeFrame: 1 hours
measure: Levels of administered sedating medications
timeFrame: 2 hours
measure: Lactate
timeFrame: 15 minutes
measure: Levels of lactate
timeFrame: 1 hour
measure: Levels of lactate
timeFrame: 2 hours
measure: Hourly urine output
timeFrame: 1 hour
measure: Hourly urine output
timeFrame: 2 hours
measure: Temperature change
timeFrame: 15 minutes
measure: Temperature change
timeFrame: 1 hour
measure: Temperature change
timeFrame: 2 hours
measure: Daily fluid balance
timeFrame: 24 hours
measure: Daily fluid balance
timeFrame: 48 hours
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Södersjukhuset
city: Stockholm
country: Sweden
facility: Danderyds sjukhus
Study officials:
affiliation: maria.cronhjort@ki.se
name: Maria Cronhjort, MD, PhD
role: STUDY_DIRECTOR
References: