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

NCT02783781 | Completed

• 3 other identifiers: 15/E/0115.8341912114
• Study Type: observational
• Target: 9,500
• Locations: 1 country
• Sites: 10

Brief 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.

Conditions

Patients Requiring Cardiac Surgery

Keywords

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

Outcome Measures

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.

  120 days

Secondary Outcomes (1)

• Evaluation criteria of risk profiles of population (French Overseas Department /Western Europe).

  120 days

Study Arms (1)

Cardiac surgery

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

Procedure: Cardiac surgery (extracorporeal circulation; beating heart)

Interventions

Cardiac surgery (extracorporeal circulation; beating heart) PROCEDURE

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

Cardiac surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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))

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Center of Martinique: lead
• Assistance Publique - Hôpitaux de Paris, FRANCE: collaborator
• Centre Hospitalier Universitaire de Bordeaux, FRANCE: collaborator
• Centre Hospitalier Universitaire de Toulouse, FRANCE: collaborator
• University Hospital, Limoges: collaborator
• Centre Hospitalier Universitaire de Clermont-Ferrand, FRANCE: collaborator
• Centre Hospitalier Universitaire de La Réunion, FRANCE: collaborator
• Centre Hospitalier Universitaire d'Angers, FRANCE: collaborator
• Centre Hospitalier Universitaire Dijon: collaborator

Study Sites (10)

CHU de Martinique

Fort-de-France, Martinique, 97261, France

Location

CHU d'Angers

Angers, 49100, France

Location

CHU de Bordeaux

Bordeaux, 33600, France

Location

CHU de Clermont-Ferrand

Clermont-Ferrand, 63000, France

Location

CHU de Dijon

Dijon, 21000, France

Location

CHU de Limoges

Limoges, 87000, France

Location

Hôpital Pitié-Salpêtrière (AP-HP)

Paris, 75013, France

Location

Hôpital Bichat (AP-HP)

Paris, 75018, France

Location

CHU de La Réunion

Saint-Denis, 97400, France

Location

CHU de Toulouse

Toulouse, 31400, France

Location

MeSH Terms

Interventions

Cardiac Surgical Procedures; Extracorporeal Circulation

Intervention Hierarchy (Ancestors)

Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Thoracic Surgical Procedures

Study Officials

• François ROQUES, MD, PhD

  Centre Hospitalier Universitaire de Martinique

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2016
• First Posted: May 26, 2016
• Study Start: August 1, 2016
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: August 1, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (10)