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

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.

Study Overview

• Status: Withdrawn
• Conditions: Sepsis; Critical Illness; Fluid Overload; Hemodynamic Instability
• Intervention / Treatment: Other: Body temperature; Drug: Fluid bolus; Other: Room temperature

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden, 118 83
    • Södersjukhuset
  • Stockholm, Sweden, 182 57
    • Danderyds Sjukhus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Collaborators: Danderyd Hospital; Stockholm South General Hospital
• Investigators: Study Director: Maria Cronhjort, MD, PhD, maria.cronhjort@ki.se

Study record dates

Study Major Dates

• Study Start (Anticipated): April 30, 2021
• Primary Completion (Anticipated): October 30, 2021
• Study Completion (Anticipated): October 30, 2021

Study Registration Dates

• First Submitted: February 23, 2020
• First Submitted That Met QC Criteria: September 29, 2020
• First Posted (Actual): October 6, 2020

Study Record Updates

• Last Update Posted (Estimate): March 10, 2023
• Last Update Submitted That Met QC Criteria: March 8, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Fluid therapy; Bolus
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: EPN 2019-05492

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No data will be shared outside the research group

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No