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

Primary Purpose

Critical Illness, Sepsis, Fluid Overload

Status
Withdrawn
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Body temperature
Fluid bolus
Room temperature
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Critical Illness focused on measuring Fluid therapy, Bolus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.)

Sites / Locations

  • Södersjukhuset
  • Danderyds sjukhus

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Body temperature fluid bolus of crystalloid

Room temperature fluid bolus of crystalloid

Arm Description

Fluid bolus at 38 degrees celsius of 500ml crystalloid over 15 minutes

Fluid bolus at 22 degrees celsius of 500ml crystalloid over 15 minutes

Outcomes

Primary Outcome Measures

MAP
Mean arterial pressure

Secondary Outcome Measures

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

Full Information

First Posted
February 23, 2020
Last Updated
March 8, 2023
Sponsor
Karolinska Institutet
Collaborators
Danderyd Hospital, Stockholm South General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04576806
Brief Title
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Other research priorities during Covid-19 pandemic.
Study Start Date
April 30, 2021 (Anticipated)
Primary Completion Date
October 30, 2021 (Anticipated)
Study Completion Date
October 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
Collaborators
Danderyd Hospital, Stockholm South General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness, Sepsis, Fluid Overload, Hemodynamic Instability
Keywords
Fluid therapy, Bolus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
RCT, unblinded
Masking
Outcomes Assessor
Masking Description
Investigators will be blinded during analysis but unblinded during study performance.
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Body temperature fluid bolus of crystalloid
Arm Type
Active Comparator
Arm Description
Fluid bolus at 38 degrees celsius of 500ml crystalloid over 15 minutes
Arm Title
Room temperature fluid bolus of crystalloid
Arm Type
Experimental
Arm Description
Fluid bolus at 22 degrees celsius of 500ml crystalloid over 15 minutes
Intervention Type
Other
Intervention Name(s)
Body temperature
Intervention Description
Warming of administered fluid bolus
Intervention Type
Drug
Intervention Name(s)
Fluid bolus
Intervention Description
Administration of fluid bolus of crystalloid of 500ml over 15 minutes
Intervention Type
Other
Intervention Name(s)
Room temperature
Intervention Description
Cooling of administered fluid bolus
Primary Outcome Measure Information:
Title
MAP
Description
Mean arterial pressure
Time Frame
15 minutes
Secondary Outcome Measure Information:
Title
MAP
Description
Systolic blood pressure
Time Frame
1 hour
Title
MAP
Description
Systolic blood pressure
Time Frame
2 hours
Title
SBP
Description
Systolic blood pressure
Time Frame
15 minutes
Title
SBP
Description
Systolic blood pressure
Time Frame
1 hour
Title
SBP
Description
Systolic blood pressure
Time Frame
2 hours
Title
DBP
Description
Diastolic blood pressure
Time Frame
15 minutes
Title
DBP
Description
Diastolic blood pressure
Time Frame
1 hour
Title
DBP
Description
Diastolic blood pressure
Time Frame
2 hours
Title
HR
Description
Heart rate
Time Frame
15 minutes
Title
HR
Description
Heart rate
Time Frame
1 hour
Title
HR
Description
Heart rate
Time Frame
2 hours
Title
CO
Description
Cardiac output
Time Frame
15 minutes
Title
CO
Description
Cardiac output
Time Frame
1 hour
Title
CO
Description
Cardiac output
Time Frame
2 hours
Title
CI
Description
Cardiac index
Time Frame
15 minutes
Title
CI
Description
Cardiac index
Time Frame
1 hour
Title
CI
Description
Cardiac index
Time Frame
2 hours
Title
SV
Description
Stroke volume
Time Frame
15 minutes
Title
SV
Description
Stroke volume
Time Frame
1 hour
Title
SV
Description
Stroke volume
Time Frame
2 hours
Title
SVV
Description
Stroke volume variation
Time Frame
15 minutes
Title
SVV
Description
Stroke volume variation
Time Frame
1 hour
Title
SVV
Description
Stroke volume variation
Time Frame
2 hours
Title
EVLW
Description
Extra vascular lung water
Time Frame
15 minutes
Title
EVLW
Description
Extra vascular lung water
Time Frame
1 hour
Title
EVLW
Description
Extra vascular lung water
Time Frame
2 hours
Title
Type ofh eart rhythm
Description
Heart rhythm
Time Frame
15 minutes
Title
Type of heart rhythm
Description
Heart rhythm
Time Frame
1 hour
Title
Type of heart rhythm
Description
Heart rhythm
Time Frame
2 hours
Title
Levels of administered vasopressors
Description
Amount of pressors
Time Frame
15 minutes
Title
Levels of administered vasopressors
Description
Amount of pressors
Time Frame
1 hours
Title
Levels of administered vasopressors
Description
Amount of pressors
Time Frame
2 hours
Title
Levels of administered sedating medications
Description
Amount of sedation
Time Frame
15 minutes
Title
Levels of administered sedating medications
Description
Amount of sedation
Time Frame
1 hours
Title
Levels of administered sedating medications
Description
Amount of sedation
Time Frame
2 hours
Title
Lactate
Description
Lactate
Time Frame
15 minutes
Title
Levels of lactate
Description
Lactate
Time Frame
1 hour
Title
Levels of lactate
Description
Lactate
Time Frame
2 hours
Title
Hourly urine output
Description
Urine output
Time Frame
1 hour
Title
Hourly urine output
Description
Urine output
Time Frame
2 hours
Title
Temperature change
Description
Temperature change
Time Frame
15 minutes
Title
Temperature change
Description
Temperature change
Time Frame
1 hour
Title
Temperature change
Description
Temperature change
Time Frame
2 hours
Title
Daily fluid balance
Description
Fluid balance
Time Frame
24 hours
Title
Daily fluid balance
Description
Fluid balance
Time Frame
48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Cronhjort, MD, PhD
Organizational Affiliation
maria.cronhjort@ki.se
Official's Role
Study Director
Facility Information:
Facility Name
Södersjukhuset
City
Stockholm
ZIP/Postal Code
118 83
Country
Sweden
Facility Name
Danderyds sjukhus
City
Stockholm
ZIP/Postal Code
182 57
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No data will be shared outside the research group

Learn more about this trial

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

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