Patients Requiring Cardiac SurgeryEuroSCOREbioNCT02783781
Contribution of Preoperative Biological Data in Risk Assessment in Cardiac Surgery in Addition to the EuroSCORE (EuroSCOREbio)
An observational study of Patients Requiring Cardiac Surgery, run by University Hospital Center of Martinique at 10 sites in France.
Trial summary
In cardiac surgery, the assessment of operative risk and quality of care is a major challenge for both patient, and surgical team. It is also important for health care decisionmakers to have predictive tools to compare alternative technics such as conventional cardiac surgery and interventional cardiology. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients Requiring Cardiac Surgery
- What is being tested?
- Cardiac surgery (extracorporeal circulation; beating heart)
- Type of treatment
- Surgery or procedure
- How many people
- 9,500 participants
- Where
- 10 sitesFrance
- Study dates
- 1 Aug 2016to 31 Dec 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients needed cardiac surgery during 1 year at the different sites (in France (8 sites), and in two French Overseas Departments (2 sites))
Who may be able to join
- Patient > 18 years old at the time of inclusion
- All patients operated on extracorporeal circulation or beating heart
- Patient affiliated to a social security scheme
- Patient having been informed of the research objectives
- Patient not objecting to participate in research
Who cannot join
- Patient receiving heart transplant
- Patient < 18 years old
- Patient refusing to participate in the study
- Pregnant women
- Protected adult (person under guardianship and trusteeship) or deprived of liberty
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
France10 sites
CHU d'Angers
Angers, 49100
CHU de Bordeaux
Bordeaux, 33600
CHU de Clermont-Ferrand
Clermont-Ferrand, 63000
CHU de Dijon
Dijon, 21000
CHU de Martinique
Fort-de-France, Martinique, 97261
CHU de Limoges
Limoges, 87000
Hôpital Pitié-Salpêtrière (AP-HP)
Paris, 75013
Hôpital Bichat (AP-HP)
Paris, 75018
CHU de La Réunion
Saint-Denis, 97400
CHU de Toulouse
Toulouse, 31400
About this study
Official title: Contribution of Preoperative Biological Data in Risk Assessment in Cardiac Surgery in Addition to the EuroSCORE
In cardiac surgery, the assessment of operative risk and quality of care is a major challenge for both patient, and surgical team. It is also important for health care decisionmakers to have predictive tools to compare alternative technics such as conventional cardiac surgery and interventional cardiology. Since 1998, the European System for Cardiac Operative Risk Evaluation (EuroSCORE), updated in 2012 (EuroSCORE II) is the most universally used system in this purpose. Its success is the result of a good balance between predictive capability and simplicity. It consists almost exclusively of clinical variables.
However, the objectivity and the predictive ability of some of those clinical items remain controversial, particularly those addressing severity of illness for high-risk patients. For instance, the degree of priority is submitted to the subjective assessment by the surgical team at the time of surgery. Objective data describing the severity of patients arriving in the operating room are still missing.
Read more
Many biomarkers are relevant in qualifying severity of syndromes: shock (PH, lactates, LDH), heart disease (N-terminal pro b-type natriuretic peptide (NTproBNP), troponin T and I), respiratory disorder (blood gaz analysis), liver insufficiency (TP, factor V), renal impairment (serum creatinine, creatinine clearance), inflammatory condition (fibrinogen, CRP), or the underlying medical condition such as diabetes (HbA1c, microalbuminuria) and nutritional status (albumin).
In ICU, many scores use biological data to measure, on daily basis, the severity of the patient status. Their routine use is simplified by applications available on smartphones. They are drawn into hospital information systems.
In cardiac surgery, some studies seem to demonstrate the measurement of some preoperative biological variables (eg NT Pro-BNP ...) in risk prediction. In terms of diabetes, HbA1c is of particular interest because it detects underlying diabetes if unknown (emergent situation) or reflects its poor control before surgery. This criterion could be more reliable than the simple information of patient treated by insulin (EuroSCORE II criterion).
Finally, the reinforcement of existing scores with biological variables is recommended by the group of recommendations in prognostic research strategy (PROGRESS 2014), rather than creating new scores ex nihilo.
The hypothesis is that adding biological data collected at the time of arrival of the patient in the operating room would better qualify the patients' severity condition and therefore increase the risk prediction of early mortality and severe morbidity after cardiac surgery. The purpose of this study is to test this hypothesis and especially test whether the biological data would increase the EuroSCORE II performance, by improving the prediction for high-risk patients.
Read the detailed description
Main objective: To improve the EuroSCORE II predictive power on the 90-day mortality and/or severe hospital morbidity, incorporating immediate preoperative biological data.
Secondary objectives:
- Analyze EuroSCORE II calibration by risk group (external validation).
- Studying the improvement of the EuroSCORE II-bio predictive power by risk class, especially high risk.
- Refine selection and definition of discriminating criteria for diabetics for predicting surgical risk in cardiac surgery (the HbA1c value, the existence of microalbuminuria, the nature of treatment etc.).
- Compare the risk profiles of operated patients in the French Overseas Departments to those from different sites of Western Europe.
- Conditions
- Patients Requiring Cardiac Surgery
- Being tested
- Cardiac surgery (extracorporeal circulation; beating heart)
- Keywords
- Cardiac surgery (extracorporeal circulation; beating heart), Biological data, Preoperative biological variables, EuroSCORE II, Risk prediction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac surgery (extracorporeal circulation; beating heart)Procedure or surgery
Patient's usual care as part of cardiac surgery, analysis of biological data collected at the time of arrival of the patient in the operating room.
Blood sample collection Urine sample collection
| Study group | Role | What they receive |
|---|---|---|
| Cardiac surgery | All patients (planned and urgent) needed cardiac surgery, and agreed to participate Receives: Procedure: Cardiac surgery (extracorporeal circulation; beating heart) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurence of mortality at 90 days and/or occurence of severe morbidity during hospitalization.
1- Mortality criterion 90-day mortality. In addition, the date of death from the surgery date and the release date from the hospital will clarify the subcategories (30-day mortality and hospital mortality).
2- Severe post operative morbidity Criteria
At least one of the following criteria:
- Intensive care hospital stay> 8 days ii. Total post operative hospital stay> 21 days (full stay including intensive care) iii. Postoperative ventilation time> 72 H and/or need for tracheotomy iv. Need for a "neo-dialysis" in postoperative v. Need for cardiac reoperation after surgery vi. Postoperative mediastinal infection vii. Permanent stroke post operatively. viii. Need for intra-aortic balloon pump or circulatory support for acute cardiopulmonary failure.
Measured: 120 days
Secondary outcomes (1)
Evaluation criteria of risk profiles of population (French Overseas Department /Western Europe).
The risk profile categories distribution in the EuroSCORE II grid, in the two subgroups (patients from French Overseas Department sites and patients of European sites).
Measured: 120 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2016 (estimated)
- Study start1 Aug 2016
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Requiring Cardiac SurgeryStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 9,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Center of Martinique
- Sponsor type
- University, hospital or other
- Collaborators
- Assistance Publique - Hôpitaux de Paris, Centre Hospitalier Universitaire de Bordeaux, FRANCE, Centre Hospitalier Universitaire de Toulouse, FRANCE, University Hospital, Limoges, Centre Hospitalier Universitaire de Clermont-Ferrand, FRANCE, Centre Hospitalier Universitaire de la Réunion, Centre Hospitalier Universitaire d'Angers, FRANCE, Centre Hospitalier Universitaire Dijon
- Responsible party
- Sponsor
- Investigators
- François ROQUES, MD, PhD, Principal investigator, Centre Hospitalier Universitaire de Martinique
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02783781
- Sponsor's protocol ID
- 15/E/01
- Other IDs
- 15.834, 1912114
- Acronym
- EuroSCOREbio
- Status last verified
- Jul 2019
- First submitted
- 24 May 2016
- Last updated
- 1 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contribution of Preoperative Biological Data in Risk Assessment in Cardiac Surgery in Addition to the EuroSCORE
- ClinicalTrials.gov ID
- NCT02783781
- Acronym / sponsor ID
- EuroSCOREbio / 15/E/01
- Conditions
- Patients Requiring Cardiac Surgery
- Keywords
- Cardiac surgery (extracorporeal circulation; beating heart), Biological data, Preoperative biological variables, EuroSCORE II, Risk prediction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9,500 participants (actual)
- Lead sponsor
- University Hospital Center of MartiniqueUniversity, hospital or other
- Collaborators
- Assistance Publique - Hôpitaux de Paris, Centre Hospitalier Universitaire de Bordeaux, FRANCE, Centre Hospitalier Universitaire de Toulouse, FRANCE, University Hospital, Limoges, Centre Hospitalier Universitaire de Clermont-Ferrand, FRANCE, Centre Hospitalier Universitaire de la Réunion, Centre Hospitalier Universitaire d'Angers, FRANCE, Centre Hospitalier Universitaire Dijon
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 26 May 2016 (estimated)
- 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.
In cardiac surgery, the assessment of operative risk and quality of care is a major challenge for both patient, and surgical team. It is also important for health care decisionmakers to have predictive tools to compare alternative technics such as conventional cardiac surgery and interventional cardiology. Since 1998, the European System for Cardiac Operative Risk Evaluation (EuroSCORE), updated in 2012 (EuroSCORE II) is the most universally used system in this purpose. Its success is the result of a good balance between predictive capability and simplicity. It consists almost exclusively of clinical variables.
However, the objectivity and the predictive ability of some of those clinical items remain controversial, particularly those addressing severity of illness for high-risk patients. For instance, the degree of priority is submitted to the subjective assessment by the surgical team at the time of surgery. Objective data describing the severity of patients arriving in the operating room are still missing.
Many biomarkers are relevant in qualifying severity of syndromes: shock (PH, lactates, LDH), heart disease (N-terminal pro b-type natriuretic peptide (NTproBNP), troponin T and I), respiratory disorder (blood gaz analysis), liver insufficiency (TP, factor V), renal impairment (serum creatinine, creatinine clearance), inflammatory condition (fibrinogen, CRP), or the underlying medical condition such as diabetes (HbA1c, microalbuminuria) and nutritional status (albumin).
In ICU, many scores use biological data to measure, on daily basis, the severity of the patient status. Their routine use is simplified by applications available on smartphones. They are drawn into hospital information systems.
In cardiac surgery, some studies seem to demonstrate the measurement of some preoperative biological variables (eg NT Pro-BNP ...) in risk prediction. In terms of diabetes, HbA1c is of particular interest because it detects underlying diabetes if unknown (emergent situation) or reflects its poor control before surgery. This criterion could be more reliable than the simple information of patient treated by insulin (EuroSCORE II criterion).
Finally, the reinforcement of existing scores with biological variables is recommended by the group of recommendations in prognostic research strategy (PROGRESS 2014), rather than creating new scores ex nihilo.
The hypothesis is that adding biological data collected at the time of arrival of the patient in the operating room would better qualify the patients' severity condition and therefore increase the risk prediction of early mortality and severe morbidity after cardiac surgery. The purpose of this study is to test this hypothesis and especially test whether the biological data would increase the EuroSCORE II performance, by improving the prediction for high-risk patients.
Detailed description
Main objective: To improve the EuroSCORE II predictive power on the 90-day mortality and/or severe hospital morbidity, incorporating immediate preoperative biological data.
Secondary objectives:
- Analyze EuroSCORE II calibration by risk group (external validation).
- Studying the improvement of the EuroSCORE II-bio predictive power by risk class, especially high risk.
- Refine selection and definition of discriminating criteria for diabetics for predicting surgical risk in cardiac surgery (the HbA1c value, the existence of microalbuminuria, the nature of treatment etc.).
- Compare the risk profiles of operated patients in the French Overseas Departments to those from different sites of Western Europe.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiac surgery | – | Procedure: Cardiac surgery (extracorporeal circulation; beating heart)All patients (planned and urgent) needed cardiac surgery, and agreed to participate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients needed cardiac surgery during 1 year at the different sites (in France (8 sites), and in two French Overseas Departments (2 sites))
Key inclusion criteria (5 listed)
- Patient > 18 years old at the time of inclusion
- All patients operated on extracorporeal circulation or beating heart
- Patient affiliated to a social security scheme
- Patient having been informed of the research objectives
- Patient not objecting to participate in research
Key exclusion criteria (5 listed)
- Patient receiving heart transplant
- Patient < 18 years old
- Patient refusing to participate in the study
- Pregnant women
- Protected adult (person under guardianship and trusteeship) or deprived of liberty
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 |
|---|---|---|
| Cardiac surgery (extracorporeal circulation; beating heart)Patient's usual care as part of cardiac surgery, analysis of biological data collected at the time of arrival of the patient in the operating room. Blood sample collection Urine sample collection | Procedure or surgery | Cardiac surgery |
Primary outcome
Occurence of mortality at 90 days and/or occurence of severe morbidity during hospitalization.
Time frame: 120 days
1- Mortality criterion 90-day mortality. In addition, the date of death from the surgery date and the release date from the hospital will clarify the subcategories (30-day mortality and hospital mortality). 2- Severe post operative morbidity Criteria At least one of the following criteria: i. Intensive care hospital stay> 8 days ii. Total post operative hospital stay> 21 days (full stay including intensive care) iii. Postoperative ventilation time> 72 H and/or need for tracheotomy iv. Need for a "neo-dialysis" in postoperative v. Need for cardiac reoperation after surgery vi. Postoperative mediastinal infection vii. Permanent stroke post operatively. viii. Need for intra-aortic balloon pump or circulatory support for acute cardiopulmonary failure.
1 secondary outcome
Evaluation criteria of risk profiles of population (French Overseas Department /Western Europe).
Time frame: 120 days
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 1 Aug 2019.
- 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.
François ROQUES, MD, PhD principal investigator
Centre Hospitalier Universitaire de Martinique
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patients Requiring Cardiac Surgery, run by University Hospital Center of Martinique at 10 sites 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 5 inclusion and 5 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 1 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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?
Occurence of mortality at 90 days and/or occurence of severe morbidity during hospitalization. (time frame: 120 days). 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 1 Aug 2019.