CClinicalTrials.gg
CompletedNCT04082312AKI-ECMOUpdated Sep 13, 2023

Acute Kidney Injury in Adult Patients Supported by VA-ECMO

An observational study in Acute Kidney Injury and Cardiogenic Shock, sponsored by Groupe Hospitalier Pitie-Salpetriere. Completed at 1 site in France. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2023-09-13.

Sponsored by Groupe Hospitalier Pitie-Salpetriere · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
347
Ages
18 Years to 99 Years
Sex
All
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Study 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.

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Conditions studied

  • Acute Kidney Injury
  • Cardiogenic Shock

Keywords

  • Acute Kidney Injury
  • ECMO
  • Post Cardiogenic Shock Syndrome
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In context

Acute Kidney Injury

1,595 studies on the registry are indexed under Acute Kidney Injury; 371 are open to participants now.

This study's enrollment of 347 is above the median of 150 across 773 observational studies indexed under Acute Kidney Injury.

Browse Acute Kidney Injury studies →

Lead sponsor

Groupe Hospitalier Pitie-Salpetriere is the lead sponsor of 65 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
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.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Retrospective
Enrollment
347 participants (actual)
Patient registry
No

Groups and 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

    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

    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

    Other: No intervention

Interventions

  • OtherNo intervention

    No intervention

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What researchers measure

Primary outcomes

  1. Occurrence of a stage 3 AKI

    Number of Participants with Stage 3 Acute Kidney Injury according to the Kidney Disease: Improving Global Outcomes (KDIGO) group

    Time frame: Day 10 after ECMO implantation

Secondary outcomes

  1. Mortality at Day 30

    Number of Deceased Participants

    Time frame: Day 30 after ECMO implantation

  2. Mortality at 6 months

    Number of Deceased Participants

    Time frame: 6 months after ECMO implantation

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Study locations

1 site
  • Dr Adrien Bouglé
    Paris, 75013, France
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References and documents

Publications

  • Lepere V, Duceau B, Lebreton G, Bombled C, Dujardin O, Boccara L, Charfeddine A, Amour J, Hajage D, Bougle A. Risk Factors for Developing Severe Acute Kidney Injury in Adult Patients With Refractory Postcardiotomy Cardiogenic Shock Receiving Venoarterial Extracorporeal Membrane Oxygenation. Crit Care Med. 2020 Aug;48(8):e715-e721. doi: 10.1097/CCM.0000000000004433. PubMed 32697513 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 13, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04082312
Lead sponsor
Groupe Hospitalier Pitie-Salpetriere
Responsible party
Adrien Bouglé (Head of Surgical Intensive Care Unit, Groupe Hospitalier Pitie-Salpetriere) — Principal investigator
First posted
Sep 9, 2019
Start date
May 1, 2016
Primary completion
May 5, 2019
Completion
Jul 5, 2019
Last update
Sep 13, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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