High-risk Patients in Cardiac Surgery Procedures: HiriSCORE

C.Surgical Procedure; Cardiac Clinical Trial

— HiriSCORE  

Official title:

An International Multicenter Prospective Study for Identify High-risk Patients in Cardiac Surgery Procedures: HiriSCORE

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02560285
• Other study ID #: USaoPauloGH1001
• Secondary ID: 1.289.986
• Status: Recruiting
• Phase: N/A
• First received: June 30, 2015
• Last updated: October 31, 2017
• Start date: January 2016
• Est. completion date: February 2020

Study information

• Verified date: October 2017
• Source: University of Sao Paulo General Hospital
• Contact: Omar AV Mejía, MD, PhD
• Phone: 55-11-26615000
• Email: omarvmejia[@]sbccv.org.br
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• C.Surgical Procedure; Cardiac

Locations

Country	Name	City	State
Brazil	Fabio B Jatene, MD, PhD	São Paulo

Sponsors (13)

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

Country where clinical trial is conducted

Brazil, 

Outcome

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

External Links

•   Data collection link
•   In this website you will be able to check the project data update