Hematologic Ratios in Postoperative Acute Kidney Injury

Study Overview
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Brief Summary
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Acute kidney injury (AKI) is a common complication after surgery for congenital heart disease and is associated with significant morbidity and mortality. To-date, no biomarker has been universally implemented for predicting AKI in neonates after cardiac surgery. In this study, the use of hematological ratios will be evaluated for predicting AKI and postoperative outcomes in this patient cohort.

Detailed Description
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In adults, hematological ratios which can be calculated from a routinely ordered complete blood count with differential, such as the neutrophil/lymphocyte ratio, have been demonstrated to be correlated with acute kidney injury (AKI) and other clinical outcomes after cardiovascular surgery. In this retrospective observational study, the association between hematological ratios (neutrophil/lymphocyte ratio, platelet/lymphocyte ratio, neutrophil/lymphocyte*platelet ratio, monocyte/lymphocyte ratio, and plateletcrit) and postoperative AKI, morbidity (length of ICU stay, hospital stay, mechanical ventilation, vasoactive infusion-free days, etc.) and mortality will be evaluated in neonates who underwent cardiac surgery with cardiopulmonary bypass.

Official Title
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Association Between Hematological Ratios and Acute Kidney Injury After Cardiovascular Surgery in Neonates: A Retrospective Observational Study

Conditions
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Acute Kidney Injury

Intervention / Treatment
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* Procedure: Cardiac Surgery with Cardiopulmonary Bypass


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Neonates (≤31 days) who underwent cardiac surgery with cardiopulmonary bypass for congenital heart disease. Exclusion Criteria: Patients with missing relevant preoperative or postoperative data points Patients with previous palliation or reoperation, Thymus hypo/aplasia (DiGeorge Syndrome, Ataxia-telangiectasia, or Nezelof syndrome), Primary immunodeficiency, Episode of cardiac arrest within 1 week before surgery, Signs or history of preoperative renal impairment or AKI (KDIGO Stage ≥1 observed on preoperative labs), Hypothyroidism, Patients with a history of infection within a week prior to surgery or antibiotics administered within the first 3 days after surgery (except for postoperative antibiotics).

Ages Eligible for Study
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Minimum Age: 0 Days
Maximum Age: 31 Days

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study Group<br>Neonates (≤31 days) who underwent cardiac surgery with cardiopulmonary bypass for congenital heart disease (CHD) between 2008-2017. | Procedure: Cardiac Surgery with Cardiopulmonary Bypass<br>* Cardiac Surgery with Cardiopulmonary Bypass<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute Kidney Injury (AKI) | Occurrence of AKI as defined by the Kidney Disease Improving Global Outcomes (KDIGO) diagnostic classification (using serum creatinine) | up to 72 hours postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative Mortality | Mortality within 30 days after surgery (rate) | up to 30 days postoperative | 
| 1-year mortality | Mortality within 1 year after surgery (rate) | up to 1 year postoperative | 
| Length of hospital stay | Total length of hospital stay (days) | up to 1 year postoperative | 
| Length of Cardiac Intensive Care Unit (CICU) Stay | Total length of stay in the CICU (days) | up to 1 year postoperative | 
| Length of mechanical ventilation | Total length of postoperative mechanical ventilator support (days) | up to 1 year postoperative | 
| Vasoactive infusion-free days | (days) | up to 28 days postoperative | 
| Postoperative infection | Occurrence of infection defined as: antibiotic use (other than perioperative) within 3 days postop, positive blood culture within 3 days postop, positive viral panel within 3 days postop | up to 3 days postoperative | 
| Low Cardiac Output Syndrome | Occurrence of Low Cardiac Output Syndrome defined as any of the following at any time during the first 48 hours postoperative: Lactate >6mmol/l and mixed venous saturation (ScvO2) <60% (or SaO2-ScvO2 difference greater than 35% in a single ventricle), Vasoactive inotropic score (VIS)3 ≥ 10, Extracorporeal Membrane Oxygenation (ECMO | up to 2 days postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Kidney Injury, Cardiac Surgery, Cardiopulmonary Bypass, Congenital Heart Disease, Biomarkers