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

Not Applicable

Withdrawn

• Conditions: Hemodynamic Instability; Critical Illness; Sepsis; Fluid Overload
• Interventions: Drug: Fluid bolus; Other: Body temperature; Other: Room temperature

• Registration Number: NCT04576806
• Lead Sponsor: Karolinska Institutet

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2020-02-23
• Study First Submitted QC: 2020-09-29
• Study First Posted: 2020-10-06
• Study Start: 2021-04-30
• Primary Completion: 2021-10-30
• Study Completion: 2021-10-30
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-08
• Last Update Posted: 2023-03-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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%

Read More

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.)

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Room temperature fluid bolus of crystalloid	Fluid bolus	Fluid bolus at 22 degrees celsius of 500ml crystalloid over 15 minutes
Body temperature fluid bolus of crystalloid	Body temperature	Fluid bolus at 38 degrees celsius of 500ml crystalloid over 15 minutes
Body temperature fluid bolus of crystalloid	Fluid bolus	Fluid bolus at 38 degrees celsius of 500ml crystalloid over 15 minutes
Room temperature fluid bolus of crystalloid	Room temperature	Fluid bolus at 22 degrees celsius of 500ml crystalloid over 15 minutes

Primary Outcome Measures

Name	Time	Method
MAP	15 minutes	Mean arterial pressure

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Södersjukhuset; 🇸🇪 Stockholm, Sweden

Danderyds sjukhus; 🇸🇪 Stockholm, Sweden