Trial Review

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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

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
ACTRN12616000083493
Ethics application status
Approved
Date submitted
19/01/2016
Date registered
27/01/2016
Date last updated
17/05/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Allostasis and Sedation Practices in the Critically Ill
Scientific title
Observational pilot study evaluating markers of physiological stress response in mechanically ventilated intensive care patients
Secondary ID [1] 288370 0
Nil Known
Universal Trial Number (UTN)
U1111-1178-7172
Trial acronym
All-SPICE OPS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multi-Organ Failure
 297365 0
Condition category
Condition code
Anaesthesiology 297553 297553 0 0
Other anaesthesiology

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Patients will have blood sampled every twelve hours for 5 days
Intervention code [1] 293671 0
Diagnosis / Prognosis
Comparator / control treatment
No Control Group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 297110 0
To determine the optimal timing for sampling as determined by the variation in the serum assays over time.
Timepoint [1] 297110 0
Every 12 hours for 5 days from enrolment
Secondary outcome [1] 320042 0
To inform a statistical plan for a larger randomised controlled study.
Timepoint [1] 320042 0
5 days

Eligibility
Key inclusion criteria
Admitted to the Intensive Care Unit
Mechanically Ventilated
Likely to be ventilated for >24hrs
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- <18yrs
- Pregnant
- Primary cardiac diagnosis
- Ventilated >12hrs
- Enrolled in the intervention arm of the SPICE study
- Primary brain lesion
- Overdose
- Burns
- MAP <50 despite adequate resuscitation
- Fulminant hepatic failure
- Full-time residential nursing care
- Imminent/inevitable death
- Unlikely to survive to 90 days

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Statistical analysis will be performed using a propriety statistical package (STATA
version 12.0). Data will be organised and trends reported using standard descriptive
statistics (mean (SD), median (IRQ), proportions). More detailed inferential analysis will
be done using regression techniques that take into account the linear and correlated
nature of the data

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
13/08/2015
Date of last participant enrolment
Anticipated
Actual
30/11/2015
Date of last data collection
Anticipated
Actual
31/12/2015
Sample size
Target
10
Accrual to date
Final
12
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 5092 0
Nambour General Hospital - Nambour
Recruitment postcode(s) [1] 12557 0
4560 - Nambour

Funding & Sponsors
Funding source category [1] 292720 0
Charities/Societies/Foundations
Name [1] 292720 0
Wishlist
Country [1] 292720 0
Australia
Primary sponsor type
Hospital
Name
Sunshine Coast Health and Hospitals District
Address
Nambour General Hospital


PO Box 547
Nambour, QLD 4560
Country
Australia
Secondary sponsor category [1] 291451 0
None
Name [1] 291451 0
Address [1] 291451 0
Country [1] 291451 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294209 0
The Prince Charles Hospital
Ethics committee address [1] 294209 0
Building 14
The Prince Charles Hospital
Rode Road
Chermside Qld 4032
Ethics committee country [1] 294209 0
Australia
Date submitted for ethics approval [1] 294209 0
26/03/2015
Approval date [1] 294209 0
01/06/2015
Ethics approval number [1] 294209 0
HREC/15/QPCH/85

Summary
Brief summary
The survival of an organism in the face of internal and external events requires a measured and appropriate stress response. Recent strands of evidence suggest that an abnormal stress response is linked to the likelihood of the development and severity of critical illness and multi-organ failure. The stress response is coordinated by primitive brain structures in response to sensory inputs and comprises a broad range of effects. We hypothesise that the use of sedating medications confuses the normal generation of a stress response. If this is confirmed, this may be a fundamental underlying cause for the abnormal physiology, metabolic disturbances and organ dysfunction observed in critical illness. The current large multi-centre randomised-controlled Sedation Practices in Intensive Care Evaluation III (SPICE-III) study, in offers the opportunity to study two similar groups of patients who may have differing levels of physiological stress as a result of an Early Goal-Directed Sedation (EGDS) strategy as compared to standard care. The proposed observational study, to be conducted at Nambour Hospital, aims to provide the investigators with pilot data to determine the optimum timing of sampling for a stress panel and to conduct a statistical plan for a randomised–controlled sub-study of the larger SPICE-III study.
Trial website
Trial related presentations / publications
None
Public notes

Contacts
Principal investigator
Name 62894 0
Dr John Moore
Address 62894 0
Sunshine Coast Institute for Critical Care Research
Department of Intensive Care
Hospital Rd
Nambour Hospital
Nambour
QLD 4560
Country 62894 0
Australia
Phone 62894 0
+61 7 54706284
Fax 62894 0
Email 62894 0
[email protected]
Contact person for public queries
Name 62895 0
Lauren Murray
Address 62895 0
Sunshine Coast Institute for Critical Care Research
Department of Intensive Care
Hospital Rd
Nambour Hospital
Nambour
QLD 4560
Country 62895 0
Australia
Phone 62895 0
+61 7 54705407
Fax 62895 0
Email 62895 0
[email protected]
Contact person for scientific queries
Name 62896 0
John Moore
Address 62896 0
Sunshine Coast Institute for Critical Care Research
Department of Intensive Care
Hospital Rd
Nambour Hospital
Nambour
QLD 4560
Country 62896 0
Australia
Phone 62896 0
+61 7 54706284
Fax 62896 0
Email 62896 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.