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

Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04576806
• Other study ID #: EPN 2019-05492
• Status: Withdrawn
• Phase: N/A
• Start date: April 30, 2021
• Est. completion date: October 30, 2021

Study information

• Verified date: March 2023
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 30, 2021
• Est. primary completion date: October 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.)

Related Conditions & MeSH terms

• Critical Illness
• Fluid Overload
• Hemodynamic Instability
• Sepsis

Intervention

Other:
• Body temperature
Warming of administered fluid bolus

Drug:
• Fluid bolus
Administration of fluid bolus of crystalloid of 500ml over 15 minutes

Other:
• Room temperature
Cooling of administered fluid bolus

Locations

Country	Name	City	State
Sweden	Danderyds sjukhus	Stockholm
Sweden	Södersjukhuset	Stockholm

Sponsors (3)

Lead Sponsor	Collaborator
Karolinska Institutet	Danderyd Hospital, Stockholm South General Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

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