Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12614000824662
Ethics application status
Approved
Date submitted
24/07/2014
Date registered
4/08/2014
Date last updated
4/04/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Fluid treatment for severe infections in children
Scientific title
Fluid resuscitation for severe paediatric sepsis: what are the effects on stroke volume, IVC collapsability, and lung ultrasound score?
Secondary ID [1] 285050 0
nil
Universal Trial Number (UTN)
U1111-1159-6761
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
septic shock 292567 0
fluid resuscitation 292568 0
Condition category
Condition code
Infection 292873 292873 0 0
Other infectious diseases
Cardiovascular 292874 292874 0 0
Other cardiovascular diseases
Respiratory 292875 292875 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Transthoracic echocardiogram to measure stroke volume pre and post fluid bolus administration. Additional measurements: IVC collapsability, extra-vascular lung water estimation on lung ultrasound, and clinical signs (heart rate, blood pressure, respiratory rate, saturations, respiratory effort, conscious state) pre and post fluid bolus administration.
Intervention code [1] 289884 0
Not applicable
Comparator / control treatment
Observational study with no control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 292744 0
Change in stroke volume assessed using transthoracic echocardiogram following fluid bolus administration (both effect size and duration).
Timepoint [1] 292744 0
5 minutes after fluid bolus administration and 60 minutes after fluid bolus administration
Secondary outcome [1] 309589 0
The ability of IVC collapsability using abdominal ultrasound to predict fluid responsiveness in spontanously ventilating children.
Timepoint [1] 309589 0
Prior to fluid bolus administration
Secondary outcome [2] 309590 0
Change in lung ultrasound score following fluid bolus administration
Timepoint [2] 309590 0
5 minutes and 60 minutes following fluid bolus administration
Secondary outcome [3] 309591 0
Change in vital signs following fluid bolus administration (heart rate measured by 3-lead ECG monitor, blood pressure by non-invasive automated oscillometric cuff, respiratory rate by direct observation, capillary refill by video-recording and blinded assessment, respiratory effort by video-recording and blinded assessment, conscious state by Glasgow Coma Score).
Timepoint [3] 309591 0
5 minutes and 60 minutes following fluid bolus administration

Eligibility
Key inclusion criteria
Suspected infection (hyperthermia or hypothermia), cardiovascular compromise (tachycardia and abnormal capillary refill time or hypotension), and a clinical decision to administer a standardised fluid bolus (20ml/kg 0.9% saline).
Minimum age
1 Days
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Underlying structural cardiac disease, English as a second language in whom true informed consent cannot be obtained, those whose goals of therapy are non-curative.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Descriptive statistics for primary outcome measure. Results will be stratified according to volume of fluid administered (nil, 20ml/kg, 40ml/kg, >40ml/kg) to determine if there is attenuation in response with larger cumulative volumes of fluid administered. Percentage change in stroke volume will be plotted over time and median duration of effect calculated. Secondary outcomes- IVC collapsibility index prior to fluid bolus administration will be calculated and compared with the percentage change in stroke volume following fluid bolus therapy. Lung ultrasound score will be compared pre and post fluid bolus administration, and compared to respiratory outcome at 24 hours. Change in vital signs following fluid bolus administration will be calculated. Pearson correlation co-efficient will be used to determine the correlation between total volume of bolus fluid administered and change in vital signs (heart rate, blood pressure, and capillary refill) and change in respiratory status (respiratory rate, respiratory effort, and lung ultrasound score) before and after fluid bolus administration. Pearson correlation co-efficient will also be used to determine the correlation between median change in stroke volume and change in vital signs (heart rate, blood pressure, and capillary refill) and change in respiratory status (respiratory rate, respiratory effort, and lung ultrasound score) before and after fluid bolus administration. To detect a 10% change in stroke volume (estimated standard deviation of 20%) with a power of 80% and a type 1 error rate of 0.05, by using a 2-sided t-test, we calculated that 48 patients would be required.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2014
Actual
6/02/2014
Date of last participant enrolment
Anticipated
2/02/2017
Actual
10/02/2017
Date of last data collection
Anticipated
Actual
24/02/2017
Sample size
Target
50
Accrual to date
Final
50
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 2767 0
The Royal Childrens Hospital - Parkville
Recruitment postcode(s) [1] 8465 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 289656 0
Self funded/Unfunded
Name [1] 289656 0
Country [1] 289656 0
Primary sponsor type
Hospital
Name
The Royal Children's Hospital
Address
50 Flemington Road
Parkville, VIC
3052
Country
Australia
Secondary sponsor category [1] 288345 0
University
Name [1] 288345 0
The University of Melbourne Department of Paediatrics
Address [1] 288345 0
1–100 Grattan Street, Parkville, Victoria, 3010
Country [1] 288345 0
Australia
Secondary sponsor category [2] 288346 0
Government body
Name [2] 288346 0
Murdoch Children's Reseach Institute
Address [2] 288346 0
9th floor, The Royal Children’s Hospital, 50 Flemington Road, Parkville, VIC 3052
Country [2] 288346 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291392 0
RCH Human Research Ethics Commitee
Ethics committee address [1] 291392 0
The Royal children's Hospital Melbourne
50 Flemington Road, Parkville, Victoria, 3052
Ethics committee country [1] 291392 0
Australia
Date submitted for ethics approval [1] 291392 0
01/11/2013
Approval date [1] 291392 0
29/11/2013
Ethics approval number [1] 291392 0
33169 A

Summary
Brief summary
: This PhD study is an observational cohort study of fluid resuscitation in children with severe sepsis. The primary aim is to determine the effect (both in size and duration) of fluid bolus therapy on stroke volume in children with severe sepsis. Secondary aims include: the ability if IVC ultrasound to predict fluid responsiveness; the ability of lung ultrasound to detect early harms from fluid bolus administration; and the correlation between fluid bolus administration and changes in vital signs.
Trial website
n/a
Trial related presentations / publications
nil
Public notes
nil
Attachments [1] 134 134 0 0
/AnzctrAttachments/366783-33169A Approval Certificate 29.11.13[1].pdf
Attachments [2] 135 135 0 0
/AnzctrAttachments/366783-PhD Protocol v23 27-11-13.doc
Attachments [3] 136 136 0 0
/AnzctrAttachments/366783-CRF v8 22 May 2014.docx
Attachments [4] 137 137 0 0
/AnzctrAttachments/366783-Phd flyer v3 27 Nov 2013.docx
Attachments [5] 138 138 0 0
/AnzctrAttachments/366783-PhD Parent Guardian Information Consent v9 28-10-13.doc
Attachments [6] 139 139 0 0
/AnzctrAttachments/366783-PhD Participant Information Consent v6 28-10-13.doc

Contacts
Principal investigator
Name 50190 0
Dr Elliot Long
Address 50190 0
Emergency Department
The Royal Children's Hospital
50 Flemington Road, Parkville, Victoria
3052
Country 50190 0
Australia
Phone 50190 0
+61 3 9345-7901
Fax 50190 0
+61 3 9345-6006
Email 50190 0
[email protected]
Contact person for public queries
Name 50191 0
Dr Elliot Long
Address 50191 0
Emergency Department
The Royal Children's Hospital
50 Flemington Road, Parkville, Victoria
3052
Country 50191 0
Australia
Phone 50191 0
+61 3 9345-7901
Fax 50191 0
+61 3 9345-6006
Email 50191 0
[email protected]
Contact person for scientific queries
Name 50192 0
Dr Elliot Long
Address 50192 0
Emergency Department
The Royal Children's Hospital
50 Flemington Road, Parkville, Victoria
3052
Country 50192 0
Australia
Phone 50192 0
+61 3 9345-7901
Fax 50192 0
+61 3 9345-6006
Email 50192 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
Current Study Results
No documents have been uploaded by study researchers.

Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
3808Basic resultsNo 366783-(Uploaded-29-06-2022-14-59-46)-Basic results summary.pdf
3974Plain language summaryNo Physiological changes following fluid bolus therap... [More Details]
4487Study results articleYes Long BMC Ped 2016 366783-(Uploaded-29-06-2022-14-57-14)-Journal results publication.pdf

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseAn observational study using ultrasound to assess physiological changes following fluid bolus administration in paediatric sepsis in the emergency department.2016https://dx.doi.org/10.1186/s12887-016-0634-6
EmbaseCardiac Index Changes with Fluid Bolus Therapy in Children with Sepsis - An Observational Study.2018https://dx.doi.org/10.1097/PCC.0000000000001534
EmbaseDoes fluid bolus therapy increase blood pressure in children with sepsis?.2020https://dx.doi.org/10.1111/1742-6723.13336
N.B. These documents automatically identified may not have been verified by the study sponsor.