Clinical trial NCT05788211: REnal reCOVery After ECMO for Cardiogenic Shock (RECOVECMO)
Official title: Predicted Long Term Renal Outcome After Medical or Postcardiotomy Refractory Cardiogenic Shock Requiring Renal Replacement Therapy Concomitant With Venoarterial Extracorporeal Membrane Oxygenation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiogenic Shock
Renal Replacement Therapy
Venoarterial Extracorporeal Membrane Oxygenation
Keywords: 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
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2023-03-28
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Complete renal recovery status according first definition
timeFrame: 90 days from AKI (acute Kidney Injury) start
measure: Complete renal recovery status according second definition
timeFrame: 90 days from AKI start
measure: Long term renal outcome
timeFrame: 2 years from AKI start
Secondary outcomes:
measure: MAKE incidence
timeFrame: 7 days , 90 days, 1 year , 2 years from AKI start
measure: MAKE incidence
timeFrame: hospital discharge, an average of 60 days from AKI start
measure: Renal recovery status
timeFrame: 7 days , 90 days, 1 year , 2 years from AKI start
measure: Renal recovery status
timeFrame: hospital discharge, an average of 60 days from AKI start
measure: vital status
timeFrame: 1 year, 2 years from AKI start
measure: renal replacement therapy status
timeFrame: 1 year, 2 years from AKI start
measure: Determination of risk factors (baseline characteristics, clinical features, medications and nephrotoxic use, ECMO parameters, RRT parameters) associated with incomplete renal recovery status
timeFrame: up to 90 days from AKI start
measure: Determination of risk factors (baseline characteristics, clinical features, medications and nephrotoxic use, ECMO parameters, RRT parameters, 90 days renal recovery status) associated with MAKE
timeFrame: up to 2 years from AKI start
Other outcomes:
Locations:
city: Pessac
country: France
facility: Bordeaux University Hospital
Study officials:
References:
citation: Bellomo R, Ronco C, Kellum JA, Mehta RL, Palevsky P; Acute Dialysis Quality Initiative workgroup. Acute renal failure - definition, outcome measures, animal models, fluid therapy and information technology needs: the Second International Consensus Conference of the Acute Dialysis Quality Initiative (ADQI) Group. Crit Care. 2004 Aug;8(4):R204-12. doi: 10.1186/cc2872. Epub 2004 May 24.
citation: Pannu N, James M, Hemmelgarn B, Klarenbach S; Alberta Kidney Disease Network. Association between AKI, recovery of renal function, and long-term outcomes after hospital discharge. Clin J Am Soc Nephrol. 2013 Feb;8(2):194-202. doi: 10.2215/CJN.06480612. Epub 2012 Nov 2.