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Trial registered on ANZCTR


Registration number
ACTRN12615001150538
Ethics application status
Approved
Date submitted
9/10/2015
Date registered
29/10/2015
Date last updated
29/10/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Indications and physiological effects of fluid bolus therapy in emergency department patients
Scientific title
Indications and physiological effects of fluid bolus therapy in emergency department patients.
Secondary ID [1] 287636 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Requirement of fluid bolus 296461 0
Emergency department admission 296506 0
Condition category
Condition code
Cardiovascular 296717 296717 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Indications and physiological efficacy of fluid bolus therapy in any patients presenting to the Emergency Department. Decision regarding the administration of the fluid bolus therapy will be at the discretion of the treating physician. The duration of follow up will be up to 4 hours after administration of fluid bolus. The data will be collected prospectively.
Intervention code [1] 293037 0
Not applicable
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 296333 0
Change in the blood pressure
Blood pressure will be measured by a non invasive blood pressure cuff.
Timepoint [1] 296333 0
at 10 minutes, 1 , 2 and 4 hour post fluid bolus administration
Primary outcome [2] 296408 0
Change in the heart rate
Heart rate - clinical assessment
Timepoint [2] 296408 0
at 10 minutes, 1 , 2 and 4 hour post fluid bolus administration
Primary outcome [3] 296411 0
Change in the Respiratory rate
Respiratory rate - clinical assessment
Timepoint [3] 296411 0
at 10 minutes, 1 , 2 and 4 hour post fluid bolus administration
Secondary outcome [1] 318197 0
Efficacy of the fluid bolus as perceived by the treating physician for each of the described indication of the fluid bolus..
Timepoint [1] 318197 0
1 hour post fluid bolus administration.as perceived by the treating physician. This will be based on the visual perception of the treating physician
Secondary outcome [2] 318291 0
Indications of fluid bolus as listed by treating physician in study log.
Timepoint [2] 318291 0
At the time of administration of the fluid bolus
Secondary outcome [3] 318292 0
Amount, type and number of fluid bolus in each patient as a composite outcome
Timepoint [3] 318292 0
Recorded at each administration
Secondary outcome [4] 318369 0
Change in Body temperature
Measured- Body thermometer
Timepoint [4] 318369 0
At 10 minutes, 1 hour, 2 hour and 4 hour after fluid administration

Eligibility
Key inclusion criteria
Any patients requiring a fluid bolus in the emergency department
Minimum age
16 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
We excluded patients if their age was less than 16 years, were transferred from another hospital, or they already had more than 1000 ml of fluids administered in the ambulance while being transferred to the hospital

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
Data will be compared with an independent sample t test or Mann–Whitney U test or chi square test as appropriate. Differences between variables over time will be analysed by paired t test or a repeated-measures analysis of variance (for multiple time points). A conventional alpha level of less than 0.05 will be used for all significance testing.

We did not have any previous data to help us with sample size calculation. Hence, we did an interim analysis after collecting data for 100 FBs. We defined fluid responders as an increase in MAP of at-least 5 mm Hg, 1 hour after administration of the FB,. We had 14% of patients who were classified as responders, hence with an assumed true prevalence of 0.14, with sensitivity of 0.8, specificity of 0.9, and power of 95% and desired precision of 0.05, we needed to study 498 FBs. We examined 500 fluid boluses in the study to allow for contingencies. .

Recruitment
Recruitment status
Completed
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)
SA
Recruitment hospital [1] 4443 0
Flinders Medical Centre - Bedford Park
Recruitment postcode(s) [1] 10651 0
5042 - Bedford Park

Funding & Sponsors
Funding source category [1] 292200 0
Hospital
Name [1] 292200 0
Dept of ICCU, Flinders Medical Centre, Australia
Address [1] 292200 0
ICCU Flinders Medical Centre
1 Flinders Drive
Bedford Park
South Australia
5042
Country [1] 292200 0
Australia
Primary sponsor type
Hospital
Name
Department of ICCU, Flinders Medical Centre
Address
ICCU Flinders Medical Centre
1 Flinders Drive
Bedford Park
South Australia
5042
Country
Australia
Secondary sponsor category [1] 290906 0
None
Name [1] 290906 0
None
Address [1] 290906 0
None
Country [1] 290906 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293670 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 293670 0
The Flats G5 – Rooms 3 and 4
Flinders Drive
Flinders Medical Centre, Bedford Park SA 5042
Ethics committee country [1] 293670 0
Australia
Date submitted for ethics approval [1] 293670 0
02/04/2014
Approval date [1] 293670 0
22/04/2014
Ethics approval number [1] 293670 0
146/14

Summary
Brief summary
A prospective study was performed in a tertiary referral centre ED, where the number, types, and volumes of fluid bolus (FB); Indications of fluid bolus.; and their perceived success rates were recorded. The physiological effect of these FBs on blood pressure (MAP, mmHg), heart rate (HR, per minute), respiratory rate (RR, per minute) and temperature (Temp, °C) were recorded before, and 10 minutes, 1 hour, 2 hour and 4 hour after the FB.

We hypothesized that, in a tertiary level ED of an Australian teaching hospital, FB therapy will have varied indications and have limited physiological efficacy.
Trial website
Trial related presentations / publications
Manuscript under preparation
Public notes

Contacts
Principal investigator
Name 60910 0
Dr Shailesh Bihari
Address 60910 0
Dept of ICCU, Flinders Medical Centre
1 Flinders Drive
Bedford Park
South Australia 5042
Country 60910 0
Australia
Phone 60910 0
+61 8 82047288
Fax 60910 0
Email 60910 0
biharishailesh@gmail.com
Contact person for public queries
Name 60911 0
Dr Shivesh Prakash
Address 60911 0
Dept of ICCU, Flinders Medical Centre
1 Flinders Drive
Bedford Park
South Australia 5042
Country 60911 0
Australia
Phone 60911 0
+61 8 82044247
Fax 60911 0
Email 60911 0
shivesh_18@yahoo.com
Contact person for scientific queries
Name 60912 0
Dr Shailesh Bihari
Address 60912 0
Dept of ICCU, Flinders Medical Centre
1 Flinders Drive
Bedford Park
South Australia 5042
Country 60912 0
Australia
Phone 60912 0
+61 8 82047288
Fax 60912 0
Email 60912 0
biharishailesh@gmail.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary