Acute Kidney Injury Clinical Trial
— AKI-ECMOOfficial title:
Risk Factors and Prognosis of Acute Kidney Injury in Peri Operative Cardiac Surgery Adult Patients Supported by VA-ECMO
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 |
Verified date | September 2023 |
Source | Groupe Hospitalier Pitie-Salpetriere |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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. |
Country | Name | City | State |
---|---|---|---|
France | Dr Adrien Bouglé | Paris |
Lead Sponsor | Collaborator |
---|---|
Groupe Hospitalier Pitie-Salpetriere |
France,
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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