Clinical trial NCT05796024: Derivation and Validation of the Extended Care (Ex-Care) Model II
Official title: Derivation and Validation of a National Multicenter In-hospital Mortality Risk Stratification Model - the Ex-Care Model II
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Postoperative Complications
Keywords: risk assessement
validation study
postoperative
mortality
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil
First posted: 2023-04-03
Enrollment: 107372
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged 16 years or older undergoing surgery in hospitals in different regions of Brazil

Brief summary: 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.

Detailed description: From four predictors collected preoperatively ( American Society of Anesthesiology Physical Status (ASA-PS) classification, age, extent of surgery and its nature - elective vs urgency/emergency), through a multilevel logistic regression, a post-surgical in-hospital mortality prediction model will be developed, the Ex-Care II model. Discrimination and calibration measures will be used to determine the accuracy of the model. In addition, each predictor will have their odds ratio calculated for the study outcome. Once this model is developed, it will have its external validity tested in a second sample, using the same accuracy metrics.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Surgery day up to 30 days postoperatively
Secondary outcomes:
measure: Develop smartphone application contemplating the new model developed
timeFrame: Preoperative
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: RS
Study officials:
affiliation: Hospital de Clínicas de Porto Alegre
name: Luciana C Stefani, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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 Anesthesiol. 2022 May-Jun;72(3):316-321. doi: 10.1016/j.bjane.2021.07.003. Epub 2021 Jul 26.