Predicting Outcomes of Cardiac Surgery-associated Acute Kidney Injury Using Biomarkers At Initiation of RRT

Study Overview
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Brief Summary
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The aim of this study was to verify the prognostic value of functional kidney biomarkers on survival and renal function recovery in cardiac surgery patients with acute kidney injury.

Detailed Description
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Cardiac surgery-associated acute kidney injury (CSA-AKI) is the second most common type of AKI after septic AKI and is associated with increased mortality and morbidity. Few biomarkers were validated as outcome-specific biomarkers in patients developing AKI after cardiac surgery at initiation of RRT. This study was designed to not only verify the prognostic value of functional kidney biomarkers on survival, but also predict it severity in order to optimize clinical decision making with respect to dialysis initiation and discontinuation.

Official Title
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Predicting Outcomes of Cardiac Surgery-associated Acute Kidney Injury Using Biomarkers At Initiation of REnal Replacement Therapy (POCKET)

Conditions
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Acute Kidney Injury

Intervention / Treatment
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* Other: Renal Replacement Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing cardiac surgery who required renal replacement therapy. Exclusion Criteria: History of End Stage Renal Disease or on Dialysis prior kidney transplantation patients with a DNR order or do not escalate care order

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Renal Replacement Therapy|Indications for RRT were defined as previously reported. Kidney Disease: Improving Global Outcomes (KDIGO) stage 2 ; severe sepsis, persistence of hypotension (for more than 6 h) despite preload optimization and use of vasopressors or catecholamines (norepinephrine or epinephrine >0.1 μg/kg/min), refractory fluid overload (worsening pulmonary edema, PaO2/FiO2 <300 mm Hg or fluid balance >10% of body weight), low probability of rapid renal recovery according to the judgment of the intensivists and nephrologists.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 28-day mortality | Death from any cause at 28 days | 28 days | 
| Dependence on renal-replacement therapy at 28 days in survivors | Dependence on renal-replacement therapy was defined as surviving dependent on RRT | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 60- and 90-day mortality | Death from any cause at 60- and 90-days | Up to 60 or 90 days | 
| Length of stay in the ICU | the length of stay in the ICU | Up to 90 days or ICU discharge | 
| Length of stay in the hospital | the length of stay in the hospital | Up to 90 days or hospital discharge | 
| Adverse events | with a focus on the complications potentially related to acute kidney injury or renal-replacement therapy during the first 7 days after enrollment | Up to 90 days | 
| the number of days free of renal-replacement therapy, mechanical ventilation at 28 days | the number of days free of renal-replacement therapy, mechanical ventilation at 28 days | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Kidney Injury, Renal Replacement Treatment, Biomarker