C.Surgical Procedure; Cardiac Clinical Trial
— HiriSCOREOfficial title:
An International Multicenter Prospective Study for Identify High-risk Patients in Cardiac Surgery Procedures: HiriSCORE
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.
Status | Recruiting |
Enrollment | 3000 |
Est. completion date | February 2020 |
Est. primary completion date | September 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Brazil | Fabio B Jatene, MD, PhD | São Paulo |
Lead Sponsor | Collaborator |
---|---|
University of Sao Paulo General Hospital | Beneficência Portuguesa de São Paulo, Cardiology Institute of the Distrito Federal, Brazil, Clinical Hospital Samuel Libânio of Pouso Alegre, Brazil, Dante Pazzanese Institute of Cardiology, Brazil, Fuwai Hospital, China, Hospital de Base, InCor Heart Institute, National Institute of Cardiology, Laranjeiras, Brazil, Novosibirsk Cardiology Recearch and Production Center, Russia, Russian Cardiology Research and Production Center, Russia, Santa Casa de Misericórdia of Marília, Brazil, TotalCor Hospital, Brazil |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mortality analysis | Patient´s mortality data collection following 30 days after the main procedure | 30 days | |
Secondary | Stroke with neurological consequences (pareses or plegia) | Stroke with neurological consequences (pareses or plegia) following 30 days after the main procedure | 30 days | |
Secondary | ST-elevation Myocardial infarction | ST- elevation Myocardial infarction following 30 days after the main procedure | 30 days | |
Secondary | Non- ST- elevation Myocardial infarction | Non- ST- elevation Myocardial infarction following 30 days after the main procedure | 30 days | |
Secondary | Deep sternal wound infection | Deep sternal wound infection following 30 days after the main procedure | 30 days | |
Secondary | Bleeding requiring reoperation | Bleeding requiring reoperation following 30 days after the main procedure | 30 days | |
Secondary | Sepsis | Sepsis following 30 days after the main procedure | 30 days | |
Secondary | Endocarditis | Endocarditis following 30 days after the main procedure | 30 days | |
Secondary | Respiratory failure | Respiratory failure following 30 days after the main procedure | 30 days | |
Secondary | Renal replacement therapy | Renal replacement therapy following 30 days after the main procedure | 30 days | |
Secondary | Hepatic failure | Hepatic failure following 30 days after the main procedure | 30 days | |
Secondary | Unplanned cardiac reoperation | Unplanned cardiac reoperation following 30 days after the main procedure | 30 days | |
Secondary | Unplanned cardiac percutaneous intervention | Unplanned cardiac percutaneous intervention following 30 days after the main procedure | 30 days |
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