The Value of Nephrocheck which is a laboratory test that can detect Severe Kidney Injury after a Heart Surgery.
Not Applicable
- Conditions
- Health Condition 1: null- Patients undergoing cardiac surgery
- Registration Number
- CTRI/2018/03/012764
- Lead Sponsor
- Ortho Clinical Diagnostic
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1 Patients who underwent cardiac surgery at NH hospital.
2 Use of indwelling urinary catheter as standard care expected for at least 48 hours after enrolment.
3 Expected to remain in the ICU for at least 48 hours after enrolment
Exclusion Criteria
1 Known AKI prior to surgery (KDIGO-2012).
2 Pregnant women.
3 Previous renal transplantation.
4 Already receiving dialysis (either acute or chronic) or in imminent need of dialysis at the time of enrolment.
- Known infection with human immunodeficiency virus (HIV) or active hepatitis (acute or chronic).
- Subjects with a history of Chronic Kidney Disease (CKD) without a baseline serum creatinine value within 6 months of enrollment
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method - Presence or absence of moderate to severe AKI (stages 2 and 3) within 48 hours of surgery. <br/ ><br>- Presence or absence of all stages of AKI within 48 hours of surgery. <br/ ><br>- AKI presence and stages to be defined based on increases in creatinine and decreased urine output, per the KDIGO guidelines). <br/ ><br>Timepoint: 48 hours after surgery
- Secondary Outcome Measures
Name Time Method -Need for dialysis during hospitalization, hospital stay, mortality for 1 month. <br/ ><br>-TO be considered as a follow up study with the same patients <br/ ><br>â?? long term outcome: need of dialysis and presence of CKD 1 year after surgery. <br/ ><br>Timepoint: 48 hours after surgery