Physiological Effects of 38°C vs. 22°C Fluid Therapy in Critically Ill Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Physiological Effects of 38°C vs. 22°C Fluid Therapy in Critically Ill Patients: A Randomized Controlled ICU Study

Conditions
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Sepsis, Critical Illness, Fluid Overload, Hemodynamic Instability

Intervention / Treatment
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* Other: Body temperature
* Drug: Fluid bolus
* Other: Room temperature


Participation Criteria
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Eligibility Criteria
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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.)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: RCT, unblinded
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Body temperature fluid bolus of crystalloid<br>Fluid bolus at 38 degrees celsius of 500ml crystalloid over 15 minutes | Other: Body temperature<br>* Warming of administered fluid bolus<br>Drug: Fluid bolus<br>* Administration of fluid bolus of crystalloid of 500ml over 15 minutes<br>|
| Experimental: Room temperature fluid bolus of crystalloid<br>Fluid bolus at 22 degrees celsius of 500ml crystalloid over 15 minutes | Drug: Fluid bolus<br>* Administration of fluid bolus of crystalloid of 500ml over 15 minutes<br>Other: Room temperature<br>* Cooling of administered fluid bolus<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MAP | Mean arterial pressure | 15 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MAP | Systolic blood pressure | 1 hour | 
| MAP | Systolic blood pressure | 2 hours | 
| SBP | Systolic blood pressure | 15 minutes | 
| SBP | Systolic blood pressure | 1 hour | 
| SBP | Systolic blood pressure | 2 hours | 
| DBP | Diastolic blood pressure | 15 minutes | 
| DBP | Diastolic blood pressure | 1 hour | 
| DBP | Diastolic blood pressure | 2 hours | 
| HR | Heart rate | 15 minutes | 
| HR | Heart rate | 1 hour | 
| HR | Heart rate | 2 hours | 
| CO | Cardiac output | 15 minutes | 
| CO | Cardiac output | 1 hour | 
| CO | Cardiac output | 2 hours | 
| CI | Cardiac index | 15 minutes | 
| CI | Cardiac index | 1 hour | 
| CI | Cardiac index | 2 hours | 
| SV | Stroke volume | 15 minutes | 
| SV | Stroke volume | 1 hour | 
| SV | Stroke volume | 2 hours | 
| SVV | Stroke volume variation | 15 minutes | 
| SVV | Stroke volume variation | 1 hour | 
| SVV | Stroke volume variation | 2 hours | 
| EVLW | Extra vascular lung water | 15 minutes | 
| EVLW | Extra vascular lung water | 1 hour | 
| EVLW | Extra vascular lung water | 2 hours | 
| Type ofh eart rhythm | Heart rhythm | 15 minutes | 
| Type of heart rhythm | Heart rhythm | 1 hour | 
| Type of heart rhythm | Heart rhythm | 2 hours | 
| Levels of administered vasopressors | Amount of pressors | 15 minutes | 
| Levels of administered vasopressors | Amount of pressors | 1 hours | 
| Levels of administered vasopressors | Amount of pressors | 2 hours | 
| Levels of administered sedating medications | Amount of sedation | 15 minutes | 
| Levels of administered sedating medications | Amount of sedation | 1 hours | 
| Levels of administered sedating medications | Amount of sedation | 2 hours | 
| Lactate | Lactate | 15 minutes | 
| Levels of lactate | Lactate | 1 hour | 
| Levels of lactate | Lactate | 2 hours | 
| Hourly urine output | Urine output | 1 hour | 
| Hourly urine output | Urine output | 2 hours | 
| Temperature change | Temperature change | 15 minutes | 
| Temperature change | Temperature change | 1 hour | 
| Temperature change | Temperature change | 2 hours | 
| Daily fluid balance | Fluid balance | 24 hours | 
| Daily fluid balance | Fluid balance | 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fluid therapy, Bolus