CClinicalTrials.gg
CompletedNCT02783781EuroSCOREbioUpdated Aug 1, 2019

Contribution of Preoperative Biological Data in Risk Assessment in Cardiac Surgery in Addition to the EuroSCORE (EuroSCOREbio)

An observational study in Patients Requiring Cardiac Surgery, sponsored by University Hospital Center of Martinique. Completed at 10 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-08-01.

Sponsored by University Hospital Center of Martinique · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
9,500
Ages
18 Years and older
Sex
All
01

Study 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. 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.

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:

  1. Analyze EuroSCORE II calibration by risk group (external validation).
  2. Studying the improvement of the EuroSCORE II-bio predictive power by risk class, especially high risk.
  3. 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.).
  4. Compare the risk profiles of operated patients in the French Overseas Departments to those from different sites of Western Europe.
02

Conditions studied

  • Patients Requiring Cardiac Surgery

Keywords

  • Cardiac surgery (extracorporeal circulation; beating heart)
  • Biological data
  • Preoperative biological variables
  • EuroSCORE II
  • Risk prediction
03

In context

Lead sponsor

University Hospital Center of Martinique is the lead sponsor of 77 studies on the registry; 20 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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))

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

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
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
9,500 participants (actual)
Patient registry
No

Groups and cohorts

  • Cardiac surgery

    All patients (planned and urgent) needed cardiac surgery, and agreed to participate

    Procedure: Cardiac surgery (extracorporeal circulation; beating heart)

Interventions

  • ProcedureCardiac 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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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).

    Time frame: 120 days

07

Study locations

10 sites
  • CHU de Martinique
    Fort-de-France, Martinique 97261, France
  • CHU d'Angers
    Angers, 49100, France
  • CHU de Bordeaux
    Bordeaux, 33600, France
  • CHU de Clermont-Ferrand
    Clermont-Ferrand, 63000, France
  • CHU de Dijon
    Dijon, 21000, France
  • CHU de Limoges
    Limoges, 87000, France
  • Hôpital Pitié-Salpêtrière (AP-HP)
    Paris, 75013, France
  • Hôpital Bichat (AP-HP)
    Paris, 75018, France
  • CHU de La Réunion
    Saint-Denis, 97400, France
  • CHU de Toulouse
    Toulouse, 31400, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 1, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02783781
Lead sponsor
University Hospital Center of Martinique
Collaborators
Assistance Publique - Hôpitaux de Paris, FRANCE, 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, FRANCE, Centre Hospitalier Universitaire d'Angers, FRANCE, Centre Hospitalier Universitaire Dijon
Responsible party
Sponsor
First posted
May 26, 2016
Start date
Aug 1, 2016
Primary completion
Dec 31, 2018
Completion
Dec 31, 2018
Last update
Aug 1, 2019

Study contacts

François ROQUES, MD, PhD
principal investigator · Centre Hospitalier Universitaire de Martinique

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion