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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

Tracking Information
First Submitted Date September 5, 2019
First Posted Date September 9, 2019
Last Update Posted Date September 11, 2019
Actual Study Start Date May 1, 2016
Actual Primary Completion Date May 5, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 9, 2019)
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
Original Primary Outcome Measures
 (submitted: September 5, 2019)
Occurrence of a stage 3 AKI [ Time Frame: Day 10 after ECMO implantation ]
Stage 3 according to the Kidney Disease: Improving Global Outcomes (KDIGO) group
Change History
Current Secondary Outcome Measures
 (submitted: September 9, 2019)
  • Mortality at Day 30 [ Time Frame: Day 30 after ECMO implantation ]
    Number of Deceased Participants
  • Mortality at 6 months [ Time Frame: 6 months after ECMO implantation ]
    Number of Deceased Participants
Original Secondary Outcome Measures
 (submitted: September 5, 2019)
  • Mortality at Day 30 [ Time Frame: Day 30 after ECMO implantation ]
    Mortality
  • Mortality at 6 months [ Time Frame: 6 months after ECMO implantation ]
    Mortality
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Acute Kidney Injury in Adult Patients Supported by VA-ECMO
Official Title Risk Factors and Prognosis of Acute Kidney Injury in Peri Operative Cardiac Surgery Adult Patients Supported by VA-ECMO
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Acute Kidney Injury
  • Cardiogenic Shock
Intervention Other: No intervention
No intervention
Study Groups/Cohorts
  • 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
    Intervention: Other: 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
    Intervention: Other: 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
    Intervention: Other: No intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 5, 2019)
347
Original Actual Enrollment Same as current
Actual Study Completion Date July 5, 2019
Actual Primary Completion Date May 5, 2019   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT04082312
Other Study ID Numbers AKI-ECMO
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Adrien Bouglé, Groupe Hospitalier Pitie-Salpetriere
Study Sponsor Groupe Hospitalier Pitie-Salpetriere
Collaborators Not Provided
Investigators Not Provided
PRS Account Groupe Hospitalier Pitie-Salpetriere
Verification Date September 2019