REnal reCOVery After ECMO for Cardiogenic Shock (RECOVECMO)

Cardiogenic Shock Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05788211
• Other study ID #: SAR CV 1
• Status: Recruiting
• Start date: January 1, 2022
• Est. completion date: April 1, 2023

Study information

• Verified date: March 2023
• Source: University Hospital, Bordeaux
• Contact: Antoine BEURTON, MD
• Phone: 557656866
• Email: antoine.beurton[@]chu-bordeaux.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 1, 2023
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Other:
• standard of care
retrospective study: standard of care

Locations

Country	Name	City	State
France	Bordeaux University Hospital	Pessac

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Complete renal recovery status according second definition	decrease in serum creatinine level below 1.25 fold its basal value	90 days from AKI start
Primary	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	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
Secondary	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
Secondary	Renal recovery status	Renal recovery status through serum creatinine measure	7 days , 90 days, 1 year , 2 years from AKI start
Secondary	Renal recovery status	Renal recovery status through serum creatinine measure	hospital discharge, an average of 60 days from AKI start
Secondary	vital status	Mortality from AKI start	1 year, 2 years from AKI start
Secondary	renal replacement therapy status	number of patients requiring renal replacement therapy assessed thanks to medical records	1 year, 2 years from AKI start
Secondary	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
Secondary	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