Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000901202
Ethics application status
Approved
Date submitted
16/10/2009
Date registered
16/10/2009
Date last updated
9/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Cystatin C and Procalcitonin as Predictors of Outcome after High Risk Cardiac Surgery
Scientific title
Cystatin C and Procalcitonin as Predictors of Outcome after High Risk Cardiac Surgery
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute kidney injury in high risk cardiac surgery 252011 0
Condition category
Condition code
Renal and Urogenital 252203 252203 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Each patient who meets the inclusion criteria for the study will have a blood test taken. The blood will be taken from either an existing intervenous device or from a vein in the patients arm. Blood will be taken pre surgery and then on days 0(post operative), 1, 3 and 5 we are looking at Cystatin C and Procalcitonin levels.
Intervention code [1] 241419 0
Early detection / Screening
Comparator / control treatment
Each patient who meets the inclusion criteria for the study will have serum Cystatin C and Procalcitonin levels measured. Patients will then be observed for post-operative adverse outcomes.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 253080 0
The primary objective of the study is to determine the relationship between serum levels of Cystatin C (measured at baseline,day 3 and day 5), and the occurrence of Acute Kidney Injury (as defined by the Risk of renal dysfunction, Injury to the kidney, Failure of kidney function, Loss of kidney function and End-stage kidney disease criteria) following high risk cardiac surgery. Also determine the relationship between serum blood levels of Procalcitonin and occurrence of post-operative infections.
Timepoint [1] 253080 0
Serum measured at baseline, day 0,1, 3 and day 5.
Secondary outcome [1] 257926 0
To determine the relationship between serum levels of Cystatin C and incidence of cardiovascular complications .
Timepoint [1] 257926 0
Within 5 days post surgery
Secondary outcome [2] 257927 0
90 day all cause mortality
Timepoint [2] 257927 0
from baseline to day 90
Secondary outcome [3] 257928 0
Length of intensive care stay and hospital stay
Timepoint [3] 257928 0
From baseline to end of intensive care stay and hospital stay
Secondary outcome [4] 257929 0
To determine the relationship between serum blood levels of Procalcitonin and occurrence of post-operative infections.
Timepoint [4] 257929 0
Within 5 days post surgery
Secondary outcome [5] 257930 0
To determine the relationship between serial serum levels of Procalcitonin and the severity of inflammatory response from cardiopulmonary bypass.
Timepoint [5] 257930 0
Within 5 days post surgery

Eligibility
Key inclusion criteria
The patient is undergoing on pump Coronary artery bypass grafting, valve or combination surgery, Age > 18 years, Willingness to give written informed consent and willingness to participate in and Comply with the study,The patient fulfils ONE of the following criteria:
Age > 70 years
Glomerular Filtration Rate < 60
History of Diabetes (noninsulin-dependent diabetes mellitus and insulin-dependent diabetes mellitus)
Documented left ventricular ejection fraction < 45%
Anticipated complex cardiac surgery (Combined Coronary artery bypass grafting-valve, > 1 valve or aortic root surgery)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The patient is receiving long term corticosteroid or immune suppressive therapy, History of Thyroid Disease, Undergoing salvage surgery,The patient has a history of a condition or psychological illness as to interfere with the patient’s ability to understand the requirements of the study, The patient receives dialysis for pre-existing Chronic Renal Failure,The patient is a renal transplant recipient,The patient is known to be pregnant

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Subjects are screened the day before surgery, consented, blood samples taken preop, day 0,1,3 and 5. Data collected on subjects for 5 days post surgery.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking not used
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Prospective cohort
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
27/09/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 243889 0
Self funded/Unfunded
Name [1] 243889 0
Intensive care research fund
Country [1] 243889 0
Australia
Primary sponsor type
Hospital
Name
Prince of Wales Hospital
Address
Adult Intensive Care Unit
Prince of Wales Hospital
Barker Street
Randwick 2031
Country
Australia
Secondary sponsor category [1] 251234 0
None
Name [1] 251234 0
Address [1] 251234 0
Country [1] 251234 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 244003 0
Prince of Wales
Ethics committee address [1] 244003 0
Ethics committee country [1] 244003 0
Australia
Date submitted for ethics approval [1] 244003 0
27/01/2009
Approval date [1] 244003 0
02/09/2009
Ethics approval number [1] 244003 0
1/09/0009

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

Contacts
Principal investigator
Name 30392 0
Address 30392 0
Country 30392 0
Phone 30392 0
Fax 30392 0
Email 30392 0
Contact person for public queries
Name 13639 0
Dr Yahya Shehabi
Address 13639 0
Prince of Wales Hospital
Adult Intensive Care Unit
Barker Street
Randwick 2031
NSW
Country 13639 0
Australia
Phone 13639 0
+61293824720
Fax 13639 0
+61293824748
Email 13639 0
Yahya.Shehabi@sesiahs.health.nsw.gov.au
Contact person for scientific queries
Name 4567 0
Dr Yahya Shehabi
Address 4567 0
Prince of Wales Hospital
Adult Intensive Care Unit
Barker Street
Randwick 2031
NSW
Country 4567 0
Australia
Phone 4567 0
+61293824720
Fax 4567 0
+61293824748
Email 4567 0
Yahya.Shehabi@sesiahs.health.nsw.gov.au

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.