Clinical trial NCT02560285: High-risk Patients in Cardiac Surgery Procedures: HiriSCORE
Official title: An International Multicenter Prospective Study for Identify High-risk Patients in Cardiac Surgery Procedures: HiriSCORE
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: C.Surgical Procedure; Cardiac
Keywords: Risk assessment
Mortality
Morbidity
Risk factor
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
Collaborators: name: InCor Heart Institute
name: Cardiology Institute of the Distrito Federal, Brazil
name: Clinical Hospital Samuel Libânio of Pouso Alegre, Brazil
name: Beneficência Portuguesa de São Paulo
name: National Institute of Cardiology, Laranjeiras, Brazil
name: Russian Cardiology Research and Production Center, Russia
name: Chinese Academy of Medical Sciences, Fuwai Hospital
name: TotalCor Hospital, Brazil
name: Dante Pazzanese Institute of Cardiology, Brazil
name: Santa Casa de Misericórdia of Marília, Brazil
name: Hospital de Base
name: Novosibirsk Cardiology Recearch and Production Center, Russia
First posted: 2015-09-25
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing cardiac surgery procedures

Brief summary: Over time there is a need to improve old and develop new risk models. Overall the assessment of mortality risk in cardiac surgery is performed with the use of preoperative risk models. The use of improved risk models and increased accuracy in the technique of preparing these mathematical systems does not have a positive impact on the level of prediction, which is still inaccurate, especially in the considered group of high risk. New models need to be built not only for a better prediction of mortality risk, if not also to predict morbidity in the group of patients at higher risk of complications after cardiac surgery procedures.

The aim of this study is:

* To construct the HiriSCORE to identify patients at higher risk of complications after cardiac surgery procedures
* Assessing the impact of pre-, intra- and postoperative period to the prognosis of morbidity and mortality in high-risk patients undergoing cardiac surgery procedures.

Detailed description: The risk predicts models are the mathematical tools for identification of the patients with complications risk after cardiac surgery procedures.

Over time, however, due to technical progress (the development of hybrid surgery, new valves and prostheses), the development of new drugs, changes in the environment and social conditions in which do patients live, there is a need to improve old and develop new models. Based on the statement that high risk patients have similar characteristics (clinical and laboratory) regardless of the procedure to which they were submitted, creating a new risk score to this group of patients must be sought. Improving the model quality was achieved by using more accurate risk assessments. In general, the assessment of mortality risk in cardiac surgery is performed with the use of preoperative risk models (EuroSCORE II, STS-score). However, the use of improved risk models and increased accuracy in the technique of preparing these mathematical systems, unfortunately, does not have a positive impact on the level of prediction, which is still inaccurate, especially in the considered group of high risk. New models need to be built not only for a better prediction of mortality risk, if not also to predict morbidity in the group of patients at higher risk of complications after cardiac surgery procedures.

The aim of this study is:

* To construct the HiriSCORE to identify patients at higher risk of complications after cardiac surgery procedures (the investigators have proposed a high-risk evaluation criteria: EuroSCORE II\> 5 or STS-score\> 5);
* Assessing the impact of pre-, intra- and postoperative period to the prognosis of subsequent morbidity and mortality in high-risk patients who have passed cardiac surgery procedures.

It was decided to conduct this research in two phases. The developmental phase is carried out for 30 months and includes an analysis of at least 2,000 patients who will pass cardiac surgery procedures in institutions and hospitals involved in the study. After this analysis, including outcomes, will be constructed the HiriSCORE, a new test-model for high-risk patients. In the validation phase of the study, which will involve a further 1,000 patients it is planned preparation and verification of effectiveness of the HiriSCORE model where it will be compared to the STS Score and the EuroSCORE II.

The study will include the patients of 18 years old or older who have undergone cardiac surgery procedures, such as coronary artery bypass grafting (isolated or combined with any heart valve intervention), heart valve surgery, and surgery on the ascending aorta (only combined with operations on the aortic valve or CABG).

Totally, it is proposed assessment of 170 variables (factors perceived risk) for each patient (preoperative, intraoperative, and up to 12 hours after surgery).

The study of mortality and postoperative complications such as renal replacement therapy, stroke, reoperation for bleeding, respiratory failure, cardiogenic shock, will be carried out within 30 days after cardiac surgery procedures.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing cardiac surgery procedures, such as coronary artery bypass grafting, heart valve surgeries, co-operations on aorta and valve or CABG and variations of this procedures, regardless of the operation or treatment outcomes
* Mortality risk with STS score\>5 or EuroSCORE II\>5

Exclusion Criteria:

* Isolated surgery on ascending aorta, aortic arch or descending aorta
* Heart transplantation
* Impossibility to include patient´s data in research

Primary outcomes:
measure: Mortality analysis
timeFrame: 30 days
Secondary outcomes:
measure: Stroke with neurological consequences (pareses or plegia)
timeFrame: 30 days
measure: ST-elevation Myocardial infarction
timeFrame: 30 days
measure: Non- ST- elevation Myocardial infarction
timeFrame: 30 days
measure: Deep sternal wound infection
timeFrame: 30 days
measure: Bleeding requiring reoperation
timeFrame: 30 days
measure: Sepsis
timeFrame: 30 days
measure: Endocarditis
timeFrame: 30 days
measure: Respiratory failure
timeFrame: 30 days
measure: Renal replacement therapy
timeFrame: 30 days
measure: Hepatic failure
timeFrame: 30 days
measure: Unplanned cardiac reoperation
timeFrame: 30 days
measure: Unplanned cardiac percutaneous intervention
timeFrame: 30 days
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Fabio B Jatene, MD, PhD
Study officials:
affiliation: Heart Institute of São Paulo Medical School
name: Fábio B Jatene, MD, PhD
role: STUDY_CHAIR
affiliation: Heart Institute of São Paulo Medical School
name: Omar AV Mejía, MD, PhD
role: STUDY_DIRECTOR
affiliation: Heart Institute of São Paulo Medical School
name: Maxim D Goncharov, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Heart Institute of São Paulo Medical School
name: Camila PS Arthur, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Heart Institute of São Paulo Medical School
name: Ricardo R Dias, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Heart Institute of São Paulo Medical School
name: Carlos MA Brandão, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Cardiology Institute
name: Rodrigo C Segalote, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Cardiology Institute
name: Diego M Ferreira, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Santa Casa de Misericórdia of Marília
name: Marcos G Tiveron, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Santa Casa de Misericórdia of Marília
name: Helton A Bomfim, N
role: PRINCIPAL_INVESTIGATOR
affiliation: Russian Cardiology Research and Production Center
name: Renat Suleimanovich Akchurin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Russian Cardiology Research and Production Center
name: Elina Evgenievna Vlasova, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: TotalCor Hospital
name: Pedro Gabriel M de Barros e Silva, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: TotalCor Hospital
name: João Galantier, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinical Hospital Samuel Libânio of Pouso Alegre
name: Alexandre C Hueb, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinical Hospital Samuel Libânio of Pouso Alegre
name: Maurício LJ Guerrieri, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital de Base of São José de Rio Preto
name: Marcelo A Nakazone, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital de Base of São José de Rio Preto
name: Mauricio N Machado, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cardiology Institute of the Distrito Federal
name: Fernando A Atik, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cardiology Institute of the Distrito Federal
name: Murilo T Macedo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Heart Institute of São Paulo Medical School
name: Luís RP Dallan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Heart Institute of São Paulo Medical School
name: José AD Santiago, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Heart Institute of São Paulo Medical School
name: Elinthon T Veronese, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Heart Institute of São Paulo Medical School
name: Pablo MA Pomerantzeff, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Heart Institute of São Paulo Medical School
name: Luiz Augusto F Lisboa, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Heart Institute of São Paulo Medical School
name: Luís Alberto O Dallan, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fuwai Hospital and Cardiovascular Institute
name: Shengshou Hu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fuwai Hospital and Cardiovascular Institute
name: Zhe Zheng, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fuwai Hospital and Cardiovascular Institute
name: Heng Zhang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Novosibirsk Cardiology Recearch and Production Complex
name: Alexander Bogachev-Prokofiev, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Instituto Dante Pazzanese de Cardiologia
name: Magaly Arrais dos Santos, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Instituto Dante Pazzanese de Cardiologia
name: Jenny Rivas de Oliveira, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Instituto Dante Pazzanese de Cardiologia
name: Luiz C Bento de Souza, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Heart Institute of São Paulo Medical School
name: Jóse H Palma da Fonseca, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Heart Institute of São Paulo Medical School
name: Filomena Regina BG Galas, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Heart Institute of São Paulo Medical School
name: Ludhmila A Hajjar, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Heart Institute of São Paulo Medical School
name: Roberto Kalil Filho, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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