Acute Kidney InjuryAKI-ECMONCT04082312
Acute Kidney Injury in Adult Patients Supported by VA-ECMO
An observational study of Acute Kidney Injury and Cardiogenic Shock, run by Groupe Hospitalier Pitie-Salpetriere at 1 site in France.
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). Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Acute Kidney Injury, Cardiogenic Shock
- How many people
- 347 participants
- Where
- 1 siteFrance
- Study dates
- 1 May 2016to 5 Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- All patients admitted in post-operative of cardiac surgery
- Assisted by VA-ECMO
Who cannot join
- Chronic hemodialysis
- Death occurring within the first 48 hours of VA-ECMO implantation
- Multiple VA-ECMO during the same hospitalization.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Risk Factors and Prognosis of Acute Kidney Injury in Peri Operative Cardiac Surgery Adult Patients Supported by VA-ECMO
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.
- Conditions
- Acute Kidney Injury, Cardiogenic Shock
- Being tested
- No intervention
- Keywords
- Acute Kidney Injury, ECMO, Post Cardiogenic Shock Syndrome
- Medical subject headings
- Acute Kidney Injury, Shock, Cardiogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 10 after ECMO implantation
Secondary outcomes (2)
Mortality at Day 30
Number of Deceased Participants
Measured: Day 30 after ECMO implantation
Mortality at 6 months
Number of Deceased Participants
Measured: 6 months after ECMO implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2019
- Study start1 May 2016
- Primary completion5 May 2019
- Study completion5 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 347 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe Hospitalier Pitie-Salpetriere
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adrien Bouglé, Groupe Hospitalier Pitie-Salpetriere
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04082312
- Sponsor's protocol ID
- AKI-ECMO
- Acronym
- AKI-ECMO
- Status last verified
- Sep 2023
- First submitted
- 5 Sep 2019
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors and Prognosis of Acute Kidney Injury in Peri Operative Cardiac Surgery Adult Patients Supported by VA-ECMO
- ClinicalTrials.gov ID
- NCT04082312
- Acronym / sponsor ID
- AKI-ECMO / AKI-ECMO
- Conditions
- Acute Kidney Injury, Cardiogenic Shock
- Keywords
- Acute Kidney Injury, ECMO, Post Cardiogenic Shock Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 347 participants (actual)
- Lead sponsor
- Groupe Hospitalier Pitie-SalpetriereUniversity, hospital or other
- Study start
- 1 May 2016 (actual)
- Primary completion
- 5 May 2019 (actual)
- Study completion
- 5 Jul 2019 (actual)
- First posted
- 9 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: No interventionPatients 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 |
| Group 2 | – | Other: No interventionPatients 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 |
| Group 3 | – | Other: No interventionPatients 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 |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- All patients admitted in post-operative of cardiac surgery
- Assisted by VA-ECMO
Key exclusion criteria (3 listed)
- Chronic hemodialysis
- Death occurring within the first 48 hours of VA-ECMO implantation
- Multiple VA-ECMO during the same hospitalization.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | Group 1, Group 2, Group 3 |
Primary outcome
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
2 secondary outcomes
Mortality at Day 30
Time frame: Day 30 after ECMO implantation
Mortality at 6 months
Time frame: 6 months after ECMO implantation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- Derived from this study: PubMed 32697513Lepere 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury and Cardiogenic Shock, run by Groupe Hospitalier Pitie-Salpetriere at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of a stage 3 AKI (time frame: Day 10 after ECMO implantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04082312, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2023.