A Study of changes in a kidney injury biomarker in patients undergoing heart surgery

Not Applicable

Completed

• Conditions: Cardiac Surgery associated Acute kidney injury; Renal and Urogenital - Kidney disease; Cardiovascular - Other cardiovascular diseases; Surgery - Other surgery

• Registration Number: ACTRN12611000949987
• Lead Sponsor: Rachael Parke

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-09-05
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Cardiac surgery patients in whom the use of cardiopulmonary bypass is planned and having one or more of the following risk factors for post operative kidney injury:

*Age above 70 years
*New York Heart Association class III/IV or impaired left ventricular function (left ventricular ejection fraction < 50%)
*Valvular surgery or concomitant valvular and coronary artery bypass graft surgery
*Redo cardiac surgery
*Insulin dependent diabetes mellitus.

Exclusion Criteria

*Age < 18 years
*Pre-existing renal impairment (preoperative plasma creatinine concentration > 1.4mg/dL)
*Preoperative insertion of an Intra Aortic Balloon Pump (IABP)
*Emergency cardiac surgery
*Planned off-pump cardiac surgery
*Known blood borne infectious disease
*Chronic inflammatory disease on immunosuppression
*Chronic moderate to high dose corticosteroid therapy (>10mg/day prednisone or equivalent)
*Enrolled in a conflicting research study

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To measure serum NGAL levels in a patient population undergoing cardiopulmonary bypass, who have at least one risk factor for development of AKI. This will be assessed using serum NGAL ELISA[Serum NGAL will be measured at baseline and then hourly following initiation of CPB for twelve hours, two hourly for six hours, and then at 24 and 48 hours post CPB.]

Secondary Outcome Measures

Name	Time	Method
AKI using RIFLE classification[first 48 hours post CPB];serum creatinine increase[first 5 days post CPB];requirement for renal replacement therapy i.e. continuous renal replacement therapy or intermittent haemodialysis[during hospital stay];length of mechanical ventilation[during hospital stay];length of ICU stay[during hospital stay];length of hospital stay[during hospital stay]