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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03178578




Registration number
NCT03178578
Ethics application status
Date submitted
21/04/2017
Date registered
7/06/2017
Date last updated
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 - 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 - 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 - 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 - 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 - 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 - 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 - 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 - 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 - 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 - 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 - 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 - 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 - 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 - 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 - 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 - 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
Gender
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 status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
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
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Austin Hospital, Melbourne Australia
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Danderyd Hospital
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT03178578
Trial related presentations / publications
Public notes

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

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03178578