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

March 8, 2023 updated by: Christer Svensen, Karolinska Institutet

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

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
MAP
Time Frame: 15 minutes
Mean arterial pressure
15 minutes

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
MAP
Time Frame: 1 hour
Systolic blood pressure
1 hour
MAP
Time Frame: 2 hours
Systolic blood pressure
2 hours
SBP
Time Frame: 15 minutes
Systolic blood pressure
15 minutes
SBP
Time Frame: 1 hour
Systolic blood pressure
1 hour
SBP
Time Frame: 2 hours
Systolic blood pressure
2 hours
DBP
Time Frame: 15 minutes
Diastolic blood pressure
15 minutes
DBP
Time Frame: 1 hour
Diastolic blood pressure
1 hour
DBP
Time Frame: 2 hours
Diastolic blood pressure
2 hours
HR
Time Frame: 15 minutes
Heart rate
15 minutes
HR
Time Frame: 1 hour
Heart rate
1 hour
HR
Time Frame: 2 hours
Heart rate
2 hours
CO
Time Frame: 15 minutes
Cardiac output
15 minutes
CO
Time Frame: 1 hour
Cardiac output
1 hour
CO
Time Frame: 2 hours
Cardiac output
2 hours
CI
Time Frame: 15 minutes
Cardiac index
15 minutes
CI
Time Frame: 1 hour
Cardiac index
1 hour
CI
Time Frame: 2 hours
Cardiac index
2 hours
SV
Time Frame: 15 minutes
Stroke volume
15 minutes
SV
Time Frame: 1 hour
Stroke volume
1 hour
SV
Time Frame: 2 hours
Stroke volume
2 hours
SVV
Time Frame: 15 minutes
Stroke volume variation
15 minutes
SVV
Time Frame: 1 hour
Stroke volume variation
1 hour
SVV
Time Frame: 2 hours
Stroke volume variation
2 hours
EVLW
Time Frame: 15 minutes
Extra vascular lung water
15 minutes
EVLW
Time Frame: 1 hour
Extra vascular lung water
1 hour
EVLW
Time Frame: 2 hours
Extra vascular lung water
2 hours
Type ofh eart rhythm
Time Frame: 15 minutes
Heart rhythm
15 minutes
Type of heart rhythm
Time Frame: 1 hour
Heart rhythm
1 hour
Type of heart rhythm
Time Frame: 2 hours
Heart rhythm
2 hours
Levels of administered vasopressors
Time Frame: 15 minutes
Amount of pressors
15 minutes
Levels of administered vasopressors
Time Frame: 1 hours
Amount of pressors
1 hours
Levels of administered vasopressors
Time Frame: 2 hours
Amount of pressors
2 hours
Levels of administered sedating medications
Time Frame: 15 minutes
Amount of sedation
15 minutes
Levels of administered sedating medications
Time Frame: 1 hours
Amount of sedation
1 hours
Levels of administered sedating medications
Time Frame: 2 hours
Amount of sedation
2 hours
Lactate
Time Frame: 15 minutes
Lactate
15 minutes
Levels of lactate
Time Frame: 1 hour
Lactate
1 hour
Levels of lactate
Time Frame: 2 hours
Lactate
2 hours
Hourly urine output
Time Frame: 1 hour
Urine output
1 hour
Hourly urine output
Time Frame: 2 hours
Urine output
2 hours
Temperature change
Time Frame: 15 minutes
Temperature change
15 minutes
Temperature change
Time Frame: 1 hour
Temperature change
1 hour
Temperature change
Time Frame: 2 hours
Temperature change
2 hours
Daily fluid balance
Time Frame: 24 hours
Fluid balance
24 hours
Daily fluid balance
Time Frame: 48 hours
Fluid balance
48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Karolinska Institutet

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Danderyd Hospital
Stockholm South General Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Maria Cronhjort, MD, PhD, maria.cronhjort@ki.se

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 30, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 30, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 23, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 29, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 6, 2020

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 10, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 8, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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