An observational study in Cardiogenic Shock, Renal Replacement Therapy and Venoarterial Extracorporeal Membrane Oxygenation, sponsored by University Hospital, Bordeaux. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-16.
Sponsored by University Hospital, Bordeaux · Observational
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.
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.
281 studies on the registry are indexed under Shock, Cardiogenic; 128 are open to participants now.
This study's enrollment of 93 is below the median of 180 across 146 observational studies indexed under Shock, Cardiogenic.
Browse Shock, Cardiogenic studies →University Hospital, Bordeaux is the lead sponsor of 803 studies on the registry; 194 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Consecutive patients having suffered of medical or post cardiotomy refractory cardiogenic shock requiring renal replacement therapy concomitant with venoarterial extracorporeal membrane oxygenation, and meeting the protocol criteria between 2012, january the first and 2020, june the first.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
All patients with medical or postcardiotomy refractory cardiogenic shock requiring renal replacement therapy concomitant with venoarterial extracorporeal membrane oxygenation.
Other: standard of care
retrospective study: standard of care
Complete renal recovery status according first definition
decrease in serum creatinine level below 1.5 fold its basal value
Time frame: 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
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: hospital discharge, an average of 60 days from AKI start
Renal recovery status
Renal recovery status through serum creatinine measure
Time frame: 7 days , 90 days, 1 year , 2 years from AKI start
Renal recovery status
Renal recovery status through serum creatinine measure
Time frame: hospital discharge, an average of 60 days from AKI start
vital status
Mortality from AKI start
Time frame: 1 year, 2 years from AKI start
renal replacement therapy status
number of patients requiring renal replacement therapy assessed thanks to medical records
Time frame: 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
Time frame: 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
Time frame: up to 2 years from AKI start
Ran from Jan 2022 to primary completion in Apr 2023, 15 months.
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This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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