REnal reCOVery After ECMO for Cardiogenic Shock (RECOVECMO)

Sponsor

University Hospital, Bordeaux (Other)

Overall Status

Recruiting

CT.gov ID

NCT05788211

Collaborator

(none)

100

Enrollment

Location

14.9

Anticipated Duration (Months)

6.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiogenic Shock Renal Replacement Therapy Venoarterial Extracorporeal Membrane Oxygenation	Other: standard of care

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Other

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Jan 1, 2022

Anticipated Primary Completion Date :

Apr 1, 2023

Anticipated Study Completion Date :

Apr 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
REFRACTORY CARDIOGENIC SHOCK 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

Arm

Intervention/Treatment

REFRACTORY CARDIOGENIC SHOCK

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

MAKE incidence [7 days , 90 days, 1 year , 2 years from AKI start]
Major Adverse Kidney Events incidence: death or dialysis dependency or serum creatinine value ≥ 200 % of the baseline serum creatinine.
MAKE incidence [hospital discharge, an average of 60 days from AKI start]
Major Adverse Kidney Events incidence: death or dialysis dependency or serum creatinine value ≥ 200 % of the baseline serum creatinine.
Renal recovery status [7 days , 90 days, 1 year , 2 years from AKI start]
Renal recovery status through serum creatinine measure
Renal recovery status [hospital discharge, an average of 60 days from AKI start]
Renal recovery status through serum creatinine measure
vital status [1 year, 2 years from AKI start]
Mortality from AKI start
renal replacement therapy status [1 year, 2 years from AKI start]
number of patients requiring renal replacement therapy assessed thanks to medical records
Determination of risk factors (baseline characteristics, clinical features, medications and nephrotoxic use, ECMO parameters, RRT parameters) associated with incomplete renal recovery status [up to 90 days from AKI start]
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
Determination of risk factors (baseline characteristics, clinical features, medications and nephrotoxic use, ECMO parameters, RRT parameters, 90 days renal recovery status) associated with MAKE [up to 2 years from AKI start]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)