REnal reCOVery After ECMO for Cardiogenic Shock (RECOVECMO)

Study Overview
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Brief Summary
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This retrospective study assesses long term renal outcome in patients having suffered medical or post cardiotomy refractory cardiogenic shock requiring renal replacement therapy (RRT) concomitant with veno-arterial extracorporeal membrane oxygenation (VA-ECMO). The authors seek to establish for accurate definition of renal recovery status predicting poor long-term renal outcomes.

Detailed Description
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Cardiogenic shock, defined as cardiac pump failure, is caused by many etiologies such as myocardial infarction, infectious diseases or post-cardiotomy. Mortality remains high and may reach 80% depending on etiologies and series ( 60% 30 days - mortality after post-cardiotomy cardiogenic shock). Extra Corporeal Life Support (ECLS) became a corner stone of refractory cardiogenic shock. This low cardiac output syndrome leeds to associated organs failure whose renal function is the first being impaired. Severity partly depends on hemodynamic instability duration and intensity. Sixty percent of patients under ECLS develop acute kidney injury (AKI) and two third of them will need renal replacement therapy (RRT), representing 40 percent of the ECLS population. In addition, RRT introduction is associated with higher mortality. In the surviving patients, there is a growing interest on long term renal outcomes. Few retrospective studies already indicate a higher 1- and 2-years incidence of major adverse kidney events (MAKE: overall mortality or dialysis dependance or doubling serum creatinine) in case of association of RRT and ECLS. Also, 90 days renal recovery status may be correlated with 2.9 higher risk of MAKE at 3 years. Nowadays, preventing those long term renal adverse events should be considered as a priority during intensive care unit stay. Optimizing renal recovery appears to be the leading strategy in clinical practice. There is a lack of standardization in defining renal recovery leading to incomparability of studies. To investigators knowledge, there is no validated definition of renal recovery in patients undergoing combined veno-arterial mode of extracorporeal oxygenation membrane (VA mode of ECMO) and renal replacement therapy. The RECOVECMO study proposes to determinate the sensitivity and specificity of two definitions of renal recovery (serum creatinine level below 1.5 fold serum creatinine basal level or serum creatinine level below 1.25 fold serum creatinine basal level) in predicting 2 years incidence of MAKE in patients undergoing renal replacement therapy while receiving VA mode of ECMO.

Official Title
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Predicted Long Term Renal Outcome After Medical or Postcardiotomy Refractory Cardiogenic Shock Requiring Renal Replacement Therapy Concomitant With Venoarterial Extracorporeal Membrane Oxygenation

Conditions
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Cardiogenic Shock, Renal Replacement Therapy, Venoarterial Extracorporeal Membrane Oxygenation

Intervention / Treatment
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* Other: standard of care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients over 18 years old Medical or post cardiotomy refractory cardiogenic shock Patients requiring concomitant renal replacement therapy (RRT) and venoarterial extracorporeal membrane oxygenation (VA-ECMO) Exclusion Criteria: Congenital heart diseases Severe pre operative chronic kidney disease (eGFR < 30ml/min/1,73m2) Death within the first 7 days of ECMO Patient receiving non-concomitant ECMO and RRT

Ages Eligible for Study
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Minimum Age: 18 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| REFRACTORY CARDIOGENIC SHOCK<br>All patients with medical or postcardiotomy refractory cardiogenic shock requiring renal replacement therapy concomitant with venoarterial extracorporeal membrane oxygenation. | Other: standard of care<br>* retrospective study: standard of care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete renal recovery status according first definition | decrease in serum creatinine level below 1.5 fold its basal value | 90 days from AKI (acute Kidney Injury) start | 
| Complete renal recovery status according second definition | decrease in serum creatinine level below 1.25 fold its basal value | 90 days from AKI start | 
| Long term renal outcome | proportion of patient meeting a composite criterion (overall mortality or dialysis dependency or doubling of basal serum creatinine) | 2 years from AKI start | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MAKE incidence | Major Adverse Kidney Events incidence: death or dialysis dependency or serum creatinine value ≥ 200 % of the baseline serum creatinine. | 7 days , 90 days, 1 year , 2 years from AKI start | 
| MAKE incidence | Major Adverse Kidney Events incidence: death or dialysis dependency or serum creatinine value ≥ 200 % of the baseline serum creatinine. | hospital discharge, an average of 60 days from AKI start | 
| Renal recovery status | Renal recovery status through serum creatinine measure | 7 days , 90 days, 1 year , 2 years from AKI start | 
| Renal recovery status | Renal recovery status through serum creatinine measure | hospital discharge, an average of 60 days from AKI start | 
| vital status | Mortality from AKI start | 1 year, 2 years from AKI start | 
| renal replacement therapy status | number of patients requiring renal replacement therapy assessed thanks to medical records | 1 year, 2 years from AKI start | 
| Determination of risk factors (baseline characteristics, clinical features, medications and nephrotoxic use, ECMO parameters, RRT parameters) associated with incomplete renal recovery status | Report data (baseline characteristics, clinical features, medications and nephrotoxic use, ECMO parameters, RRT parameters) present at inclusion or appearing during the follow-up of patients who have not completely recovered their renal function 90 days after the start of AKI | up to 90 days from AKI start | 
| Determination of risk factors (baseline characteristics, clinical features, medications and nephrotoxic use, ECMO parameters, RRT parameters, 90 days renal recovery status) associated with MAKE | Report data present at inclusion or appearing during the follow-up of patients (baseline characteristics, clinical features, medications and nephrotoxic use, ECMO parameters, RRT parameters, 90 days renal recovery status) associated with MAKE, up to 2 years after the start of AKI | up to 2 years from AKI start | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiogenic shock, Renal replacement therapy, venoarterial extracorporeal membrane oxygenation, extra corporeal life support, major adverse kidney events, acute kidney injury, end-stage renal disease, serum creatinine