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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03178578
Registration number
NCT03178578
Ethics application status
Date submitted
21/04/2017
Date registered
7/06/2017
Titles & IDs
Public title
A Prospective Observational Study of the Expectations and Physiological Effects of Fluid Bolus Therapy
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Scientific title
A Prospective Observational Study of the Expectations and Physiological Effects of Fluid Bolus Therapy in the Intensive Care Unit
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Secondary ID [1]
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LNR/17/Austin/94
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hypovolemia
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0
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Sepsis
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Post-operative Hypovolemia
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Fluid Therapy
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Condition category
Condition code
Blood
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0
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Other blood disorders
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Accuracy of anticipated hemodynamic effects at completion of bolus
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Assessment method [1]
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The accuracy and precision between the expected and the observed physiological effects will be described using Bland-Altman methodology
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Timepoint [1]
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At completion of bolus
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Secondary outcome [1]
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Accuracy of anticipated hemodynamic effects at one hour after completion of the fluid bolus
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Assessment method [1]
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The accuracy and precision between the expected and the observed physiological effects will be described using Bland-Altman methodology
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Timepoint [1]
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At one hour after completion of the fluid bolus
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Secondary outcome [2]
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The hemodynamic effects of a fluid bolus at completion of bolus
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Assessment method [2]
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The effect of the fluid bolus on blood pressure at completion of bolus will be described.
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Timepoint [2]
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At completion of bolus
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Secondary outcome [3]
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The hemodynamic effects of a fluid bolus at one hour after completion of the fluid bolus
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Assessment method [3]
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The effect of the fluid bolus on blood pressure one hour after completion of the fluid bolus will be described.
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Timepoint [3]
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At one hour after completion of the fluid bolus
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Secondary outcome [4]
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The hemodynamic effects of a fluid bolus at completion of bolus
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Assessment method [4]
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The effect of the fluid bolus on heart rate at completion of bolus will be described.
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Timepoint [4]
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At completion of bolus
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Secondary outcome [5]
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The hemodynamic effects of a fluid bolus at one hour after completion of the fluid bolus
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Assessment method [5]
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The effect of the fluid bolus on heart rate one hour after completion of the fluid bolus will be described.
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Timepoint [5]
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At one hour after completion of the fluid bolus
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Secondary outcome [6]
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The hemodynamic effects of a fluid bolus at completion of bolus
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Assessment method [6]
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The effect of the fluid bolus on cardiac index at completion of bolus will be described.
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Timepoint [6]
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At completion of bolus
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Secondary outcome [7]
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The hemodynamic effects of a fluid bolus at one hour after completion of the fluid bolus
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Assessment method [7]
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The effect of the fluid bolus on cardiac index one hour after completion of the fluid bolus will be described.
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Timepoint [7]
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At one hour after completion of the fluid bolus
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Secondary outcome [8]
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The hemodynamic effects of a fluid bolus at completion of bolus
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Assessment method [8]
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The effect of the fluid bolus on CVP at completion of bolus will be described.
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Timepoint [8]
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At completion of bolus
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Secondary outcome [9]
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The hemodynamic effects of a fluid bolus at one hour after completion of the fluid bolus
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Assessment method [9]
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The effect of the fluid bolus on CVP one hour after completion of the fluid bolus will be described.
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Timepoint [9]
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At one hour after completion of the fluid bolus
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Secondary outcome [10]
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The hemodynamic effects of a fluid bolus at completion of bolus
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Assessment method [10]
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The effect of the fluid bolus on ScVO2 or SvO2 at completion of bolus will be described.
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Timepoint [10]
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At completion of bolus
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Secondary outcome [11]
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The hemodynamic effects of a fluid bolus at one hour after completion of the fluid bolus
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Assessment method [11]
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The effect of the fluid bolus on ScVO2 or SvO2 one hour after completion of the fluid bolus will be described.
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Timepoint [11]
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At one hour after completion of the fluid bolus
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Secondary outcome [12]
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The hemodynamic effects of a fluid bolus at completion of bolus
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Assessment method [12]
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The effect of the fluid bolus on lactate levels at completion of bolus will be described.
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Timepoint [12]
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At completion of bolus
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Secondary outcome [13]
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The hemodynamic effects of a fluid bolus at one hour after completion of the fluid bolus
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Assessment method [13]
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The effect of the fluid bolus on lactate levels one hour after completion of the fluid bolus will be described.
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Timepoint [13]
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At one hour after completion of the fluid bolus
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Secondary outcome [14]
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The hemodynamic effects of a fluid bolus at completion of bolus
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Assessment method [14]
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The effect of the fluid bolus on urine output at completion of bolus will be described.
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Timepoint [14]
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At completion of bolus
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Secondary outcome [15]
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The hemodynamic effects of a fluid bolus at one hour after completion of the fluid bolus
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Assessment method [15]
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The effect of the fluid bolus on urine output one hour after completion of the fluid bolus will be described.
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Timepoint [15]
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At one hour after completion of the fluid bolus
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Eligibility
Key inclusion criteria
* Patients admitted to the intensive care unit and prescribed a fluid bolus.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* The intensive care physician declines to participate.
* Expected survival < 24h
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
UNKNOWN
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
18/05/2017
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/01/2020
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Actual
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Sample size
Target
100
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Austin Hospital - Melbourne
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Recruitment postcode(s) [1]
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- Melbourne
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Recruitment outside Australia
Country [1]
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Sweden
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State/province [1]
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Danderyd
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Country [2]
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Sweden
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State/province [2]
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Stockholm
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Funding & Sponsors
Primary sponsor type
Other
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Name
Karolinska Institutet
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Austin Hospital, Melbourne Australia
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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Danderyd Hospital
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Address [2]
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Country [2]
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Ethics approval
Ethics application status
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Summary
Brief summary
This prospective observational study aims to (i) asses intensive care doctors trigger for and the expected physiological response to a fluid bolus and (ii) evaluate the patient's actual physiological response to a single fluid bolus at one hour post-bolus for 100 adult patients admitted to the intensive care unit will be included in the study.
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Trial website
https://clinicaltrials.gov/study/NCT03178578
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Christer Svensen, MD,PhD,Prof
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Address
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Karolinska Institutet
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Maria Cronhjort, MD, PhD
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Address
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Country
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Phone
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+466161000
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT03178578