REnal reCOVery After ECMO for Cardiogenic Shock (RECOVECMO)
NCT ID: NCT05788211
Last Updated: 2024-05-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
93 participants
OBSERVATIONAL
2022-01-01
2023-04-01
Brief Summary
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The authors seek to establish for accurate definition of renal recovery status predicting poor long-term renal outcomes.
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Detailed Description
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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.
Conditions
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Study Design
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OTHER
RETROSPECTIVE
Study Groups
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REFRACTORY CARDIOGENIC SHOCK
All patients with medical or postcardiotomy refractory cardiogenic shock requiring renal replacement therapy concomitant with venoarterial extracorporeal membrane oxygenation.
standard of care
retrospective study: standard of care
Interventions
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standard of care
retrospective study: standard of care
Eligibility Criteria
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Inclusion Criteria
* Medical or post cardiotomy refractory cardiogenic shock
* Patients requiring concomitant renal replacement therapy (RRT) and venoarterial extracorporeal membrane oxygenation (VA-ECMO)
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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University Hospital, Bordeaux
OTHER
Responsible Party
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Alexandre OUATTARA
Head of department of Cardiovascular Anesthesia and Critical care
Locations
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Bordeaux University Hospital
Pessac, , France
Countries
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References
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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.
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.
Other Identifiers
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SAR CV 1
Identifier Type: -
Identifier Source: org_study_id
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