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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
Scientific title
A Prospective Observational Study of the Expectations and Physiological Effects of Fluid Bolus Therapy in the Intensive Care Unit
Secondary ID [1] 0 0
LNR/17/Austin/94
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypovolemia 0 0
Sepsis 0 0
Post-operative Hypovolemia 0 0
Fluid Therapy 0 0
Condition category
Condition code
Blood 0 0 0 0
Other blood disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Accuracy of anticipated hemodynamic effects at completion of bolus
Assessment method [1] 0 0
The accuracy and precision between the expected and the observed physiological effects will be described using Bland-Altman methodology
Timepoint [1] 0 0
At completion of bolus
Secondary outcome [1] 0 0
Accuracy of anticipated hemodynamic effects at one hour after completion of the fluid bolus
Assessment method [1] 0 0
The accuracy and precision between the expected and the observed physiological effects will be described using Bland-Altman methodology
Timepoint [1] 0 0
At one hour after completion of the fluid bolus
Secondary outcome [2] 0 0
The hemodynamic effects of a fluid bolus at completion of bolus
Assessment method [2] 0 0
The effect of the fluid bolus on blood pressure at completion of bolus will be described.
Timepoint [2] 0 0
At completion of bolus
Secondary outcome [3] 0 0
The hemodynamic effects of a fluid bolus at one hour after completion of the fluid bolus
Assessment method [3] 0 0
The effect of the fluid bolus on blood pressure one hour after completion of the fluid bolus will be described.
Timepoint [3] 0 0
At one hour after completion of the fluid bolus
Secondary outcome [4] 0 0
The hemodynamic effects of a fluid bolus at completion of bolus
Assessment method [4] 0 0
The effect of the fluid bolus on heart rate at completion of bolus will be described.
Timepoint [4] 0 0
At completion of bolus
Secondary outcome [5] 0 0
The hemodynamic effects of a fluid bolus at one hour after completion of the fluid bolus
Assessment method [5] 0 0
The effect of the fluid bolus on heart rate one hour after completion of the fluid bolus will be described.
Timepoint [5] 0 0
At one hour after completion of the fluid bolus
Secondary outcome [6] 0 0
The hemodynamic effects of a fluid bolus at completion of bolus
Assessment method [6] 0 0
The effect of the fluid bolus on cardiac index at completion of bolus will be described.
Timepoint [6] 0 0
At completion of bolus
Secondary outcome [7] 0 0
The hemodynamic effects of a fluid bolus at one hour after completion of the fluid bolus
Assessment method [7] 0 0
The effect of the fluid bolus on cardiac index one hour after completion of the fluid bolus will be described.
Timepoint [7] 0 0
At one hour after completion of the fluid bolus
Secondary outcome [8] 0 0
The hemodynamic effects of a fluid bolus at completion of bolus
Assessment method [8] 0 0
The effect of the fluid bolus on CVP at completion of bolus will be described.
Timepoint [8] 0 0
At completion of bolus
Secondary outcome [9] 0 0
The hemodynamic effects of a fluid bolus at one hour after completion of the fluid bolus
Assessment method [9] 0 0
The effect of the fluid bolus on CVP one hour after completion of the fluid bolus will be described.
Timepoint [9] 0 0
At one hour after completion of the fluid bolus
Secondary outcome [10] 0 0
The hemodynamic effects of a fluid bolus at completion of bolus
Assessment method [10] 0 0
The effect of the fluid bolus on ScVO2 or SvO2 at completion of bolus will be described.
Timepoint [10] 0 0
At completion of bolus
Secondary outcome [11] 0 0
The hemodynamic effects of a fluid bolus at one hour after completion of the fluid bolus
Assessment method [11] 0 0
The effect of the fluid bolus on ScVO2 or SvO2 one hour after completion of the fluid bolus will be described.
Timepoint [11] 0 0
At one hour after completion of the fluid bolus
Secondary outcome [12] 0 0
The hemodynamic effects of a fluid bolus at completion of bolus
Assessment method [12] 0 0
The effect of the fluid bolus on lactate levels at completion of bolus will be described.
Timepoint [12] 0 0
At completion of bolus
Secondary outcome [13] 0 0
The hemodynamic effects of a fluid bolus at one hour after completion of the fluid bolus
Assessment method [13] 0 0
The effect of the fluid bolus on lactate levels one hour after completion of the fluid bolus will be described.
Timepoint [13] 0 0
At one hour after completion of the fluid bolus
Secondary outcome [14] 0 0
The hemodynamic effects of a fluid bolus at completion of bolus
Assessment method [14] 0 0
The effect of the fluid bolus on urine output at completion of bolus will be described.
Timepoint [14] 0 0
At completion of bolus
Secondary outcome [15] 0 0
The hemodynamic effects of a fluid bolus at one hour after completion of the fluid bolus
Assessment method [15] 0 0
The effect of the fluid bolus on urine output one hour after completion of the fluid bolus will be described.
Timepoint [15] 0 0
At one hour after completion of the fluid bolus

Eligibility
Key inclusion criteria
* Patients admitted to the intensive care unit and prescribed a fluid bolus.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* The intensive care physician declines to participate.
* Expected survival < 24h

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/05/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/01/2020
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Austin Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
Sweden
State/province [1] 0 0
Danderyd
Country [2] 0 0
Sweden
State/province [2] 0 0
Stockholm

Funding & Sponsors
Primary sponsor type
Other
Name
Karolinska Institutet
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Austin Hospital, Melbourne Australia
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Danderyd Hospital
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Christer Svensen, MD,PhD,Prof
Address 0 0
Karolinska Institutet
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Maria Cronhjort, MD, PhD
Address 0 0
Country 0 0
Phone 0 0
+466161000
Email 0 0
maria.cronhjort@sll.se
Contact person for scientific queries

Data sharing statement


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