The REPLICCAR Registry and The Statewide Quality Improvement Initiative

Cardiac Surgical Procedures Clinical Trial

— REPLICCAR  

Official title:

Paulista Cardiovascular Surgery Registry (REPLICCAR)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05363696
• Other study ID #: 450617006
• Status: Completed
• Start date: August 1, 2013
• Est. completion date: August 1, 2019

Study information

• Verified date: May 2019
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Cardiovascular diseases remain the leading cause of death for the healthcare system and cardiac surgery has an important impact on their resolubility. Healthcare systems in the world have evolved to optimize their clinical records and thus learn from the real world through the interactivity between results, processes, and structure. When the rate of growth of healthcare costs scenario is greater than the one of Gross Domestic Product of countries, there is a considerable challenge to increment the quality of healthcare services and the primordial patient safety, as well as the necessary control and traceability of implantable devices. The association and correlation of patients' demographic and clinically relevant information with the resources required for the care provided for each stratum represent the possibility to adapt, improve and innovate the healthcare programs; This will allow improving the optimization of the therapeutic protocols and the creation of related research areas, aiming to promote more equitable resources allocation, increase access and effectiveness, as well as to ascertain the magnitude of available and used resources and its impact.

Description:

METHODS Extension Cohort study, mandatory, prospective multicenter, in the state of São Paulo and of registry of consecutive cases. Besides the situational diagnostic of the results and comparison between the mean of both registries, there will be the creation of improvement reports for each of the REPLICCAR centers.

Next, quality improvement initiatives will be implemented in each center indicated by the reports.

Sample

• Will be included in a consecutive way all patients that had CABG and heart valve surgery in the participant centers for the defined period;

• Data will be collected, independently of surgical volume, severity status, and social condition among others, in sight of the São Paulo state health department;

• This way, it will be possible to produce a predictive curve to be used in most clinical case scenarios observed in the state of São Paulo;

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9723
• Est. completion date: August 1, 2019
• Est. primary completion date: September 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Age 18- 90 years old.

• CABG or heart valve surgery

• Agreement to participate in the study signing informed consent documentation.

Exclusion Criteria:

• Re-operation

• Impossibility to access data variables relevant to the study.

Related Conditions & MeSH terms

• Cardiac Surgical Procedures

Intervention

Procedure:
• Coronary artery bypass grafting (CABG)
Coronary artery bypass grafting surgery procedure
• Heart valve surgery
Heart valve surgery procedure

Locations

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

Sponsors (14)

Lead Sponsor

Collaborator

University of Sao Paulo General Hospital

Beneficência Portuguesa de São Paulo, Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto - USP, Hospital das Clinicas da Universidade Estadual de Campinas, Hospital de Base de São Jose do Rio Preto, Hospital Israelita Albert Einstein, Hospital Pitangueiras do Grupo SOBAM, Hospital Samaritano Paulista, Hospital São Paulo da Universidade Federal de São Paulo, Instituto Dante Pazzanese de Cardiologia, Instituto do Coração do Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo, Irmandade da Santa Casa de Misericórdia de Marília, Irmandade da Santa Casa de Misericórdia de Piracicaba, Irmandade da Santa Casa de Misericórdia de São Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

Orlandi BMM, Mejia OAV, Borgomoni GB, Goncharov M, Rocha KN, Bassolli L, Melo de Barros E Silva PG, Nakazone MA, Sousa A, Campagnucci VP, de Sousa Vilarinho KA, Katz M, Tiveron MG, Arrais Dos Santos M, Lisboa LAF, Dallan LAO, Jatene FB; REPLICCAR II Study — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Create and implementing data driven quality initiatives for cardiac surgery procedures in São Paulo state	Guided by the database, quality initiatives will be built in order to reduce mortality, length of stay and complications in the centers participating in REPLICCAR.	5 years
Secondary	Create a morbidity and mortality risk score	Create a morbidity and mortality risk score, in order to guide the care and interventions of patients undergoing cardiac procedures, in order to prevent morbidity and mortality outcomes.	5 years
Secondary	Long-term follow-up of patients included in the database	Long-term follow-up of patients included in the database, providing an opportunity to assess quality of life, evolution and deaths after hospital discharge.	10 years
Secondary	Assessment of the impact of patients' socioeconomic variation in its surgical evolution	Assessment of the impact of patients' socioeconomic variation on their evolution in terms of morbidity and mortality (short and long term).	10 years