Cardiogenic ShockPC-ECLSNCT04330651
Post-Surgery Extracorporeal Life Support
An observational study of Cardiogenic Shock and Extracorporeal Life Support, run by University of Florence at 1 site in Italy.
Trial summary
Extracorporeal Life Support (ECLS) may provide pulmonary and circulatory support for patients with acute heart failure refractory to conventional medical therapy. However, indications and effectiveness of ECLS engagement post-surgery remains a concern. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cardiogenic Shock, Extracorporeal Life Support, Extracorporeal Membrane Oxygenation Complication
- What is being tested?
- ECLS
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2004to 31 Jan 2029
- How long will I take part?
- 20 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- Adult, Older adult
Study population: Patients underwent cardiac surgery
Who may be able to join
- Patients underwent cardiac surgery
Who cannot join
- Age < 18 years
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Massimo Bonacchi
Florence, 50144
Massimo Bonacchi, MD, 393389855782, mbonacchi@unifi.it
Sandro Gelsomino, MD
About this study
Official title: Outcomes' Predictors in Post-Surgery Extracorporeal Life Support
Extracorporeal Life Support (ECLS) may provide pulmonary and circulatory support for patients with acute heart failure refractory to conventional medical therapy. However, indications and effectiveness of ECLS engagement post-surgery remains a concern. The investigators sought to analyze indications, modality and outcomes of PS-ECLS, to identify predictors of early and midterm survival after PS-ECLS. The investigators have recorded prospectively, and analysed data of 209 consecutive PS-ECLS patients between January 2004 and December 2018. Demographic and clinical data before, during and after PS-ECLS were collected and their influence on hospital mortality and outcomes (early and midterm) will analyse. Multivariate analysis of pre PS-ECLS implantation factors (as age, female sex , insulin-dependent diabetes, pulmonary hypertension, STS, type of surgical procedure data, pre-ECLS blood lactate level) will be made for identify prognostic risk factors of in-hospital mortality. Overall survival will be analysed, at 6 months,1-year and 5-years, respectively and the factors influencing mild/term outcome will be investigated.
- Conditions
- Cardiogenic Shock, Extracorporeal Life Support, Extracorporeal Membrane Oxygenation Complication, Post Cardiac Arrest Syndrome, Post-cardiac Surgery
- Being tested
- ECLS
- Keywords
- extracorporeal life support, ecls, ecmo, outocome, prognostic factors, extracorporeal membrane oxygenation
- Medical subject headings
- Shock, Cardiogenic, Post-Cardiac Arrest Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECLSProcedure or surgery
Emergency application of Extracorporeal Life Support in post-surgical patients
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Evaluate Early, mid and late Survival
Measured: 1 month after surgery
Survival
mid-time survival
Measured: At 1 Year after surgery
Survival
late survival
Measured: At 5 years after surgery
Secondary outcomes (2)
Prognostic factors
Identify early and late negative and positive prognostic factors
Measured: Early: 1 month after surgery
Prognostic Factors
Identify early and late negative and positive prognostic factors
Measured: Late: 5 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2020
- Study startJan 2004
- Primary completion19 Mar 2021
- Study completion31 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiogenic ShockStudies 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
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 20 Years
Sponsor and investigators
- Lead sponsor
- University of Florence
- Sponsor type
- University, hospital or other
- Collaborators
- Sandro Gelsomino, Edvin Prifti, Francesco Cabrucci, Marco Bugetti, Orlando Parise, Aleksander Dokollari
- Responsible party
- Principal investigator, Massimo Bonacchi, University of Florence
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04330651
- Sponsor's protocol ID
- PC-ECLS Study
- Acronym
- PC-ECLS
- Status last verified
- Apr 2021
- First submitted
- 19 Mar 2020
- Last updated
- 28 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes' Predictors in Post-Surgery Extracorporeal Life Support
- ClinicalTrials.gov ID
- NCT04330651
- Acronym / sponsor ID
- PC-ECLS / PC-ECLS Study
- Conditions
- Cardiogenic Shock, Extracorporeal Life Support, Extracorporeal Membrane Oxygenation Complication, Post Cardiac Arrest Syndrome, Post-cardiac Surgery
- Keywords
- extracorporeal life support, ecls, ecmo, outocome, prognostic factors, extracorporeal membrane oxygenation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of FlorenceUniversity, hospital or other
- Collaborators
- Sandro Gelsomino, Edvin Prifti, Francesco Cabrucci, Marco Bugetti, Orlando Parise, Aleksander Dokollari
- Study start
- Jan 2004
- Primary completion
- 19 Mar 2021 (actual)
- Study completion
- 31 Jan 2029 (estimated)
- First posted
- 1 Apr 2020 (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.
Extracorporeal Life Support (ECLS) may provide pulmonary and circulatory support for patients with acute heart failure refractory to conventional medical therapy. However, indications and effectiveness of ECLS engagement post-surgery remains a concern. The investigators sought to analyze indications, modality and outcomes of PS-ECLS, to identify predictors of early and midterm survival after PS-ECLS. The investigators have recorded prospectively, and analysed data of 209 consecutive PS-ECLS patients between January 2004 and December 2018. Demographic and clinical data before, during and after PS-ECLS were collected and their influence on hospital mortality and outcomes (early and midterm) will analyse. Multivariate analysis of pre PS-ECLS implantation factors (as age, female sex , insulin-dependent diabetes, pulmonary hypertension, STS, type of surgical procedure data, pre-ECLS blood lactate level) will be made for identify prognostic risk factors of in-hospital mortality. Overall survival will be analysed, at 6 months,1-year and 5-years, respectively and the factors influencing mild/term outcome will be investigated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 20 Years
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients underwent cardiac surgery
Key inclusion criteria (1 listed)
- Patients underwent cardiac surgery
Key exclusion criteria (1 listed)
- Age < 18 years
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 |
|---|---|---|
| ECLSEmergency application of Extracorporeal Life Support in post-surgical patients | Procedure or surgery | – |
Primary outcome
Survival
Time frame: 1 month after surgery
Evaluate Early, mid and late Survival
Survival
Time frame: At 1 Year after surgery
mid-time survival
Survival
Time frame: At 5 years after surgery
late survival
2 secondary outcomes
Prognostic factors
Time frame: Early: 1 month after surgery
Prognostic Factors
Time frame: Late: 5 years after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
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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.
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 Cardiogenic Shock and Extracorporeal Life Support, run by University of Florence at 1 site in Italy.
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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 28 Apr 2021. 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 Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival (time frame: 1 month after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Apr 2021.