Postoperative Complications Clinical Trial
— Ex-CareIIOfficial title:
Derivation and Validation of a National Multicenter In-hospital Mortality Risk Stratification Model - the Ex-Care Model II
Verified date | March 2023 |
Source | Hospital de Clinicas de Porto Alegre |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The goal of this study is to develop a novel surgical risk stratification tool designed to adults operated in Brazil. The main question it aims to answer is: •Is the Extended Care (Ex-Care) II model a good tool to assess the risk of death among patients operated in Brazilian hospitals within 30 days after surgery? Information of patients undergoing surgery in the participating hospitals over a period of 24 months will be analyzed to evaluate the relationship of some patients characteristics (called predictors) with the study outcome (probability of death). The sample will be divided in two groups. The first, called derivation sample, will be used for the development of the Ex-Care II model. The second, called validation sample, will evaluate the performance of this new model.
Status | Active, not recruiting |
Enrollment | 107372 |
Est. completion date | November 30, 2023 |
Est. primary completion date | December 31, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 16 Years and older |
Eligibility | Inclusion Criteria: - Patients from 16 years of age undergoing elective, urgent or emergency surgeries in the hospitals participating in the study Exclusion Criteria: - Diagnostic procedures, with sedation only or with local anesthesia - Patients undergoing liver, pulmonary and/or cardiac transplant surgery, as well as those diagnosed with brain death submitted to organ donation - In the event that the patient undergoes more than one surgical intervention in the same hospitalization, only the major procedure will be considered for the purpose of denouement |
Country | Name | City | State |
---|---|---|---|
Brazil | Hospital de Clínicas de Porto Alegre | Porto Alegre | RS |
Lead Sponsor | Collaborator |
---|---|
Hospital de Clinicas de Porto Alegre | Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil |
Brazil,
Passos SC, Stahlschmidt A, Blanco J, Spader ML, Brandao RB, Castro SMJ, Gutierrez CS, Silva Neto PCD, Stefani LPC. Derivation and validation of a national multicenter mortality risk stratification model - the ExCare model: a study protocol. Braz J Anesthe — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Develop and validate a model for predicting the risk of in-hospital death within 30 days postoperatively, from a sample composed of patients operated in Brazil | From four predictors collected preoperatively, the developed model will be able to estimate the probability of in-hospital death of patients undergoing surgery in Brazilian hospitals. For the creation of this tool, multilevel logistic regression will be made with hospital as a random effect | Surgery day up to 30 days postoperatively | |
Secondary | Develop smartphone application contemplating the new model developed | In order to facilitate the use of the Ex-Care II model by health professionals involved in perioperative care, it will be created and made available on the main platforms for smartphones application that will allow the measurement of surgical risk by this new tool. | Preoperative |
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