Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000576224
Ethics application status
Approved
Date submitted
10/07/2009
Date registered
14/07/2009
Date last updated
6/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Observational Study and follow up of a Sepsis Biomarker for Sepsis Diagnosis in the Intensive Care
Scientific title
Observational Study on the Efficacy of an Insulin Sensitivity-Based Sepsis Biomarker as a Diagnosis for the
Severity of Sepsis in the Intensive Care and Long Term follow up
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sepsis 237216 0
Diabetes 237217 0
Condition category
Condition code
Infection 237532 237532 0 0
Other infectious diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Baseline blood samples will be taken from all patients enrolled. Theses samples include electrolytes, arterial blood gas, complete blood count, C-reactive protein, lactate, Interluken-6 (IL-6), procalcitonin and oxidised protein sepsis markers.

Patients who are suspected to have sepsis (given antibiotics) and/or has systemic inflammatory response score (SIRS)>=3 will have complete sepsis biomarkers blood tests. The complete sepsis biomarkers blood tests consist of blood samples taken at T=0 (time of onset of sickness), T=12 hrs, T=24 hrs, T=48 hrs and time of recovery (no sooner than T=72 hrs).

At T=0, blood samples are taken for bacterial cultural if suspected for sepsis, electrolytes, arterial blood gas, complete blood count, prothrombin ration, activated partial thromboplastin time (APTT), fibrinogen, C-reactive protein, lactate, Interluken-6 (IL-6), procalcitonin and oxidised protein sepsis markers. In addition, during the first hour, blood samples for insulin and c-peptide will be taken at T=0, 10, 40 and 60 mins.

At T=12 hrs, blood samples are taken for electrolytes, arterial blood gas, complete blood count, C-reactive protein, lactate, Interluken-6 (IL-6), procalcitonin and oxidised protein sepsis markers.

At T=24 hrs, blood samples are taken for bacterial cultural if suspected for sepsis, electrolytes, arterial blood gas, complete blood count, C-reactive protein, lactate, Interluken-6 (IL-6), procalcitonin and oxidised protein sepsis markers.

At T=48 hrs, blood samples are taken for electrolytes, arterial blood gas, complete blood count, C-reactive protein, Interluken-6 (IL-6), procalcitonin and oxidised protein sepsis markers.

Once patient recovers, defined as SIRS<=2 for 6 hours after T=72 hrs or transferring out of ICU in <=12 hours, blood samples are taken for electrolytes, arterial blood gas, complete blood count, C-reactive protein, Interluken-6 (IL-6), procalcitonin and oxidised protein sepsis markers. In addition, blood samples for insulin and c-peptide will be taken at T=0, 10, 40 and 60 mins from time of recovery.
Intervention code [1] 236913 0
Not applicable
Comparator / control treatment
none
Control group
Uncontrolled

Outcomes
Primary outcome [1] 238345 0
Correlation between model-based and biological based sepsis biomarker and the
severity of sepsis. The correlation will be calculated using a bivariate method. In addition, operating receiver characteristic (ROC) curve will be used to assess the sensitivity and specificity of the biomarkers.
Timepoint [1] 238345 0
baseline, T=0 hr when suspected sepsis and/or Systemic Inflammatory Response Score (SIRS)>=3, T=12 hrs, T=24 hrs, T=48 hrs and time of recovery.
Secondary outcome [1] 244762 0
Incidence of diabetes in patients who develop hyperglycaemia during their Intensive Care Unit (ICU) stay
Timepoint [1] 244762 0
2, 5 and 10 years after patient's stay in ICU

Eligibility
Key inclusion criteria
Critically ill patients who are on the SPRINT glycaemic control protocol age >=16 years
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Moribund or not expected to live for longer than 72 hours. Anticipated stay in ICU<=48 hrs.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment outside Australia
Country [1] 1878 0
New Zealand
State/province [1] 1878 0

Funding & Sponsors
Funding source category [1] 237309 0
Government body
Name [1] 237309 0
Foundation of Research, Science and Technology
Country [1] 237309 0
New Zealand
Primary sponsor type
Hospital
Name
Intensive Care Unit, Christchurch Hospital
Address
Riccarton Avenue
Private Bag 4710
Christchurch
Country
New Zealand
Secondary sponsor category [1] 236794 0
University
Name [1] 236794 0
University of Otago Christchurch
Address [1] 236794 0
2 Riccarton Avenue, PO Box 4345
Christchurch 8140
Country [1] 236794 0
New Zealand
Other collaborator category [1] 757 0
University
Name [1] 757 0
University of Canterbury
Address [1] 757 0
Canterbury University
Private Bag 4800
Christchurch 8140
Country [1] 757 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239407 0
Upper South B Regional Ethics Committee
Ethics committee address [1] 239407 0
Ministry of Health
4th Floor 250 Oxford Tce
PO Box 3877
Christchurch 8140
Ethics committee country [1] 239407 0
New Zealand
Date submitted for ethics approval [1] 239407 0
24/11/2008
Approval date [1] 239407 0
04/02/2009
Ethics approval number [1] 239407 0
URB/08/12/059

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29881 0
Address 29881 0
Country 29881 0
Phone 29881 0
Fax 29881 0
Email 29881 0
Contact person for public queries
Name 13128 0
Jessica Lin
Address 13128 0
Department of Medicine
University of Otago Christchurch
2 Riccarton Avenue
PO Box 4345
Christchurch 8140
Country 13128 0
New Zealand
Phone 13128 0
+64 3 3786305
Fax 13128 0
Email 13128 0
[email protected]
Contact person for scientific queries
Name 4056 0
Jessica Lin
Address 4056 0
Department of Medicine
University of Otago Christchurch
2 Riccarton Avenue
PO Box 4345
Christchurch 8140
Country 4056 0
New Zealand
Phone 4056 0
+64 3 3786305
Fax 4056 0
Email 4056 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.