Cystatin C and Procalcitonin as Predictors of Outcome after High Risk Cardiac Surgery

Not Applicable

Recruiting

• Conditions: Acute kidney injury in high risk cardiac surgery; Renal and Urogenital - Other renal and urogenital disorders

• Registration Number: ACTRN12609000901202
• Lead Sponsor: Prince of Wales Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-10-16
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 200

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)

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

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.[Serum measured at baseline, day 0,1, 3 and day 5.]

Secondary Outcome Measures

Name	Time	Method
To determine the relationship between serum levels of Cystatin C and incidence of cardiovascular complications .[Within 5 days post surgery];90 day all cause mortality[from baseline to day 90];Length of intensive care stay and hospital stay[From baseline to end of intensive care stay and hospital stay];To determine the relationship between serum blood levels of Procalcitonin and occurrence of post-operative infections.[Within 5 days post surgery];To determine the relationship between serial serum levels of Procalcitonin and the severity of inflammatory response from cardiopulmonary bypass.[Within 5 days post surgery]