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Acute Kidney Injury in Adult Patients Supported by VA-ECMO (AKI-ECMO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04082312
Recruitment Status : Completed
First Posted : September 9, 2019
Last Update Posted : September 11, 2019
Sponsor:
Information provided by (Responsible Party):
Adrien Bouglé, Groupe Hospitalier Pitie-Salpetriere

Brief Summary:
Post-cardiotomy cardiogenic shock (PCCS) occurs in 2-6% of patients undergoing cardiac surgery, and 1% of cardiac surgery patients will require mechanical circulatory support using Veno-Arterial ExtraCorporeal Membrane Oxygenation (VA-ECMO). Acute Kidney Injury is a frequent complication in this population and negatively impacts the survival. We aimed to determine whether the timing of ECMO implantation influence the renal prognosis of these patients.

Condition or disease Intervention/treatment
Acute Kidney Injury Cardiogenic Shock Other: No intervention

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Study Type : Observational
Actual Enrollment : 347 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Risk Factors and Prognosis of Acute Kidney Injury in Peri Operative Cardiac Surgery Adult Patients Supported by VA-ECMO
Actual Study Start Date : May 1, 2016
Actual Primary Completion Date : May 5, 2019
Actual Study Completion Date : July 5, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Group/Cohort Intervention/treatment
Group 1
Patients admitted in the surgical intensive care unit in post-operative of cardiac surgery between January 2013 and December 2016 + Assisted by VA-ECMO + with KDIGO stage 3 AKI
Other: No intervention
No intervention

Group 2
Patients admitted in the surgical intensive care unit in post-operative of cardiac surgery between January 2013 and December 2016 + Assisted by VA-ECMO + without KDIGO stage 3 AKI and alive at D10
Other: No intervention
No intervention

Group 3
Patients admitted in the surgical intensive care unit in post-operative of cardiac surgery between January 2013 and December 2016 + Assisted by VA-ECMO + died before D10 without KDIGO stage 3 AKI
Other: No intervention
No intervention




Primary Outcome Measures :
  1. Occurrence of a stage 3 AKI [ Time Frame: Day 10 after ECMO implantation ]
    Number of Participants with Stage 3 Acute Kidney Injury according to the Kidney Disease: Improving Global Outcomes (KDIGO) group


Secondary Outcome Measures :
  1. Mortality at Day 30 [ Time Frame: Day 30 after ECMO implantation ]
    Number of Deceased Participants

  2. Mortality at 6 months [ Time Frame: 6 months after ECMO implantation ]
    Number of Deceased Participants



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
All patients admitted in the Surgical Intensive Care Unit of the Cardiology Institute of La Pitié Salpêtrière University Hospital (Paris, France) between January 2013 and December 2016.
Criteria

Inclusion Criteria:

  • All patients admitted in post-operative of cardiac surgery
  • Assisted by VA-ECMO

Exclusion Criteria:

  • Chronic hemodialysis
  • Death occurring within the first 48 hours of VA-ECMO implantation
  • Multiple VA-ECMO during the same hospitalization.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04082312


Locations
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France
Dr Adrien Bouglé
Paris, France, 75013
Sponsors and Collaborators
Groupe Hospitalier Pitie-Salpetriere
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Responsible Party: Adrien Bouglé, Head of Surgical Intensive Care Unit, Groupe Hospitalier Pitie-Salpetriere
ClinicalTrials.gov Identifier: NCT04082312    
Other Study ID Numbers: AKI-ECMO
First Posted: September 9, 2019    Key Record Dates
Last Update Posted: September 11, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Adrien Bouglé, Groupe Hospitalier Pitie-Salpetriere:
Acute Kidney Injury
ECMO
Post Cardiogenic Shock Syndrome
Additional relevant MeSH terms:
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Acute Kidney Injury
Shock, Cardiogenic
Wounds and Injuries
Shock
Pathologic Processes
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Myocardial Infarction
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases