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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04082312
Other study ID # AKI-ECMO
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 1, 2016
Est. completion date July 5, 2019

Study information

Verified date September 2023
Source Groupe Hospitalier Pitie-Salpetriere
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 347
Est. completion date July 5, 2019
Est. primary completion date May 5, 2019
Accepts healthy volunteers
Gender All
Age group 18 Years to 99 Years
Eligibility 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.

Study Design


Intervention

Other:
No intervention
No intervention

Locations

Country Name City State
France Dr Adrien Bouglé Paris

Sponsors (1)

Lead Sponsor Collaborator
Groupe Hospitalier Pitie-Salpetriere

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Day 10 after ECMO implantation
Secondary Mortality at Day 30 Number of Deceased Participants Day 30 after ECMO implantation
Secondary Mortality at 6 months Number of Deceased Participants 6 months after ECMO implantation
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