Patients Requiring Cardiac Surgery Clinical Trial
— EuroSCOREbioOfficial title:
Contribution of Preoperative Biological Data in Risk Assessment in Cardiac Surgery in Addition to the EuroSCORE
| Verified date | July 2019 |
| Source | University Hospital Center of Martinique |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 9500 |
| Est. completion date | December 31, 2018 |
| Est. primary completion date | December 31, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
| Country | Name | City | State |
|---|---|---|---|
| France | CHU d'Angers | Angers | |
| France | CHU de Bordeaux | Bordeaux | |
| France | CHU de Clermont-Ferrand | Clermont-Ferrand | |
| France | CHU de Dijon | Dijon | |
| France | CHU de Martinique | Fort-de-France | Martinique |
| France | CHU de Limoges | Limoges | |
| France | Hôpital Bichat (AP-HP) | Paris | |
| France | Hôpital Pitié-Salpêtrière (AP-HP) | Paris | |
| France | CHU de La Réunion | Saint-Denis | |
| France | CHU de Toulouse | Toulouse |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital Center of Martinique | Assistance Publique - Hôpitaux de Paris, FRANCE, Centre Hospitalier Universitaire d’Angers, FRANCE, Centre Hospitalier Universitaire de Bordeaux, FRANCE, Centre Hospitalier Universitaire de Clermont-Ferrand, FRANCE, Centre Hospitalier Universitaire de La Réunion, FRANCE, Centre Hospitalier Universitaire de Toulouse, FRANCE, Centre Hospitalier Universitaire Dijon, University Hospital, Limoges |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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: 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. |
120 days | |
| Secondary | 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). | 120 days |