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Completed

NCT Number: NCT05788211

REnal reCOVery After ECMO for Cardiogenic Shock (RECOVECMO)

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard of care

Other

retrospective study: standard of care

Primary outcomes

  1. Complete renal recovery status according first definition

    Time frame: 90 days from AKI (acute Kidney Injury) start

    decrease in serum creatinine level below 1.5 fold its basal value

  2. Complete renal recovery status according second definition

    Time frame: 90 days from AKI start

    decrease in serum creatinine level below 1.25 fold its basal value

  3. Long term renal outcome

    Time frame: 2 years from AKI start

    proportion of patient meeting a composite criterion (overall mortality or dialysis dependency or doubling of basal serum creatinine)

Secondary outcomes

  1. MAKE incidence

    Time frame: 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.

  2. MAKE incidence

    Time frame: 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.

  3. Renal recovery status

    Time frame: 7 days , 90 days, 1 year , 2 years from AKI start

    Renal recovery status through serum creatinine measure

  4. Renal recovery status

    Time frame: hospital discharge, an average of 60 days from AKI start

    Renal recovery status through serum creatinine measure

  5. vital status

    Time frame: 1 year, 2 years from AKI start

    Mortality from AKI start

  6. renal replacement therapy status

    Time frame: 1 year, 2 years from AKI start

    number of patients requiring renal replacement therapy assessed thanks to medical records

  7. Determination of risk factors (baseline characteristics, clinical features, medications and nephrotoxic use, ECMO parameters, RRT parameters) associated with incomplete renal recovery status

    Time frame: 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

  8. Determination of risk factors (baseline characteristics, clinical features, medications and nephrotoxic use, ECMO parameters, RRT parameters, 90 days renal recovery status) associated with MAKE

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Official study title

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

Acronym: RECOVECMO

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 28, 2023
Registry last updated
May 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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