Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000497505
Ethics application status
Approved
Date submitted
19/10/2006
Date registered
4/12/2006
Date last updated
16/12/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Predicting Rehydration Requirements in Children using Capillary gas measurement
Scientific title
Predicting the Need for Hospital Care in Paediatric Gastroenteritis using Capillary blood measurement
Secondary ID [1] 288175 0
Nil known
Universal Trial Number (UTN)
Trial acronym
PRRICC trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Children with gastroenteritis 1474 0
Condition category
Condition code
Oral and Gastrointestinal 1570 1570 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Utility of using capillary gas results to predict admission to hospital from the emergency department in children with gastroenteritis, defined as vomiting and/or diarrhoea due to a presumed infectious cause.
Capillary gas measurement is a test using a spring loaded lancet to make a finger or heel prick, similar to that used for blood sugar testing. The few drops of blood are then drawn into a capillary tube and analyzed on a blood gas machine. This is a routine form of testing in most paediatric emergency departments. This test is done at the time of enrolment of the child in the trial, and prior to the decision regarding admission to hospital or discharge from the emergency department. The doctor is not made aware of the capillary gas result so that their decision to admit or discharge is not affected by these results.
The capillary gas results will be analyzed once the entire trial period is completed (approximately 100 enrolled patients), comparing the results from those patients who were admitted for treatment of gastroenteritis with those who did not require treatment and looking for significant differences between the groups.
Intervention code [1] 1413 0
Early detection / Screening
Comparator / control treatment
Patients who did not require treatment
Control group
Active

Outcomes
Primary outcome [1] 2166 0
Admission to hospital from the emergency department for rehydration by nasogastric or intravenous fluids against discharge home on oral fluids
Timepoint [1] 2166 0
Discharge from the emergency department (to inpatient location or to home)
Secondary outcome [1] 3781 0
Length of stay (in hours or days) as an inpatient in hospital (measured at discharge from hospital) if admission to hospital was required.
Timepoint [1] 3781 0
At time of discharge

Eligibility
Key inclusion criteria
Any child with clinical diagnosis of gastroenteritis.
Minimum age
6 Months
Maximum age
6 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Consent not obtained from parents, unable to process a capillary gas sample.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
23/08/2006
Actual
23/08/2006
Date of last participant enrolment
Anticipated
Actual
25/10/2007
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
95
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 1712 0
Hospital
Name [1] 1712 0
Princess Margaret Hospital
Country [1] 1712 0
Australia
Primary sponsor type
Individual
Name
Dr. Michael Lovegrove
Address
Princess Margaret Hospital, Perth, Western Australia
Country
Australia
Secondary sponsor category [1] 1511 0
Individual
Name [1] 1511 0
Dr. Meredith Borland
Address [1] 1511 0
Princess Margaret Hospital, Perth, Western Australia
Country [1] 1511 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3170 0
Princess Margaret Hospital
Ethics committee address [1] 3170 0
Ethics committee country [1] 3170 0
Australia
Date submitted for ethics approval [1] 3170 0
Approval date [1] 3170 0
20/07/2006
Ethics approval number [1] 3170 0
EC06-63

Summary
Brief summary
Predicting how well a child will respond to treatment for gastroenteritis is difficult and means that children often spend many hours in the emergency department. Blood tests can sometimes help predict how unwell a child is, but take some time to be done. We propose to do a fingerprick blood test called a capillary gas which can be tested quickly and done with minor discomfort only and analyze the results to see if we can predict which children need admission. We anticipate that the more unwell children will need admission, and that there will be changes on their blood tests that we can use to predict this. If we can prove that this works, it will reduce the amount of time that they will have to stay in the emergency department.
Trial website
Trial related presentations / publications
The trial has been written up and submitted but was not accepted for publication in its original form. A review of the submission addressing the concerns raised by the editor has been made and the trial will be resubmitted for publication once this has been completed.
Public notes

Contacts
Principal investigator
Name 27347 0
Dr Michael Lovegrove
Address 27347 0
Princess Margaret Hospital, Perth, Western Australia
Country 27347 0
Australia
Phone 27347 0
+61 8 9340 8222
Fax 27347 0
Email 27347 0
[email protected]
Contact person for public queries
Name 10602 0
Dr Dr. Michael Lovegrove
Address 10602 0
Emergency Department
Princess Margaret Hospital
Roberts Rd.
Subiaco WA 6008
Country 10602 0
Australia
Phone 10602 0
+61 8 93408222
Fax 10602 0
Email 10602 0
[email protected]
Contact person for scientific queries
Name 1530 0
Dr Dr. Michael Lovegrove
Address 1530 0
Emergency Department
Princess Margaret Hospital
Roberts Rd.
Subiaco WA 6008
Country 1530 0
Australia
Phone 1530 0
+61 8 93408222
Fax 1530 0
Email 1530 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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.