- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07621211
Social Deprivation and Postoperative Mortality
Assessment of the Impact of Socioeconomic Factors on Perioperative Outcomes
Socioeconomic factors are associated with differences in health outcomes, but their impact on surgical patients is still not well understood, especially in low- and middle-income countries. Social deprivation may affect perioperative outcomes through differences in access to healthcare, burden of comorbidities, timing of care, and hospital resources. However, few studies have evaluated this association in large and diverse surgical populations, and data from Brazil are limited.
This retrospective multicenter cohort study will evaluate the association between socioeconomic deprivation and perioperative outcomes among patients undergoing surgery in Brazil. The study will include patients aged 16 years or older who underwent elective or urgent surgical procedures in participating public and private hospitals between January 1 and December 31, 2024. Patients undergoing ophthalmologic procedures, diagnostic procedures, procedures performed under local anesthesia only, selected transplant procedures, and organ donors after brain death will be excluded.
Socioeconomic deprivation will be assessed using georeferenced area-level indices derived from each patient's residential address, including the Brazilian Deprivation Index, the Social Vulnerability Index, and the Municipal Human Development Index. The researchers will grou patients according to deprivation levels, and analyze the association between deprivation and postoperative outcomes.
The primary outcome will be 30-day in-hospital postoperative mortality. The study will also evaluate demographic, clinical, surgical, and hospital-level factors associated with mortality, including age, sex, ethnicity, American Society of Anesthesiologists physical status classification, surgical urgency, surgical magnitude, surgical specialty, and type of healthcare system. Multivariable logistic regression models will be used to assess whether socioeconomic deprivation is independently associated with postoperative mortality after adjustment for relevant clinical and surgical factors.
The results of this study may improve the understanding of how socioeconomic deprivation influences perioperative risk in Brazil. The findings may help identify vulnerable surgical patients, support risk prediction models that include social determinants of health, and inform strategies to reduce inequities in perioperative care.
Visão geral do estudo
Status
Condições
Descrição detalhada
Socioeconomic deprivation is a multidimensional determinant of health that may influence perioperative outcomes through several pathways, including differences in baseline health status, burden of comorbidities, access to timely healthcare, perioperative optimization, and hospital-level resources. Although previous studies have suggested an association between social deprivation and worse postoperative outcomes, most available evidence comes from high-income countries or from studies focused on specific surgical populations. Data from low- and middle-income countries, including Brazil, remain limited.
This study is a retrospective, multicenter cohort study designed to assess the association between socioeconomic deprivation and perioperative outcomes among surgical patients treated in Brazilian hospitals. Participating centers will include both public and private hospitals from different regions of the country. The study will use routinely collected institutional data from patients who underwent surgical procedures during the 2024 calendar year. No additional contact, intervention, or change in clinical care will occur as part of the study.
The main exposure of interest is socioeconomic deprivation, assessed through georeferenced area-level indicators based on each patient's residential address. Residential addresses will be geocoded to identify the corresponding census tract or human development unit. Socioeconomic deprivation will then be measured using validated Brazilian indices, including the Brazilian Deprivation Index, the Social Vulnerability Index, and the Municipal Human Development Index. These indices capture different dimensions of socioeconomic context, including income, education, household conditions, urban infrastructure, human capital, and vulnerability related to work and income.
The study database will include demographic, clinical, surgical, and structural variables routinely available in hospital electronic records. These variables include age, sex, ethnicity, American Society of Anesthesiologists physical status classification, educational level, occupation, surgical procedure, surgical urgency, date of surgery, date of hospital discharge or in-hospital death, surgical specialty, surgical magnitude, and type of healthcare system. Surgical procedures will be standardized using Brazilian procedural classification systems (Classificação Brasileira Hierarquizada de Procedimentos Médicos -CBHPM). If a patient undergoes more than one eligible surgical procedure during the study period, only the first procedure will be considered for outcome analysis.
Data will be extracted locally by the information technology teams of participating centers using structured database queries. Identifiable patient information will not be included in the analytical dataset. Residential addresses will be used only for geocoding and linkage to area-level socioeconomic indices. After geospatial processing, the final research dataset will exclude full residential addresses and other direct identifiers. Access to study data will be restricted to authorized members of the research team, and data will be stored in a secure institutional environment.
The primary analysis will evaluate whether higher levels of socioeconomic deprivation are associated with 30-day in-hospital postoperative mortality. Deprivation indices will be analyzed in categories, including quintiles, to assess gradients of risk across socioeconomic strata. Baseline characteristics will be summarized across deprivation groups using appropriate descriptive statistics. Multivariable logistic regression models will be used to estimate the association between socioeconomic deprivation and postoperative mortality after adjustment for relevant demographic, clinical, surgical, and hospital-level factors. Planned covariates include age, sex, ethnicity, ASA physical status, surgical urgency, surgical magnitude, surgical specialty, and healthcare system type.
Model performance will be assessed using calibration and discrimination measures. Calibration will be evaluated using the Hosmer-Lemeshow goodness-of-fit test, and discrimination will be assessed using the area under the receiver operating characteristic curve. Results will be reported as odds ratios with 95% confidence intervals. A significance level of 5% will be used for statistical analyses.
The study also aims to explore whether incorporating socioeconomic deprivation into perioperative risk assessment may improve the identification of vulnerable surgical patients. By evaluating social deprivation alongside established clinical and surgical risk factors, this study may contribute to a better understanding of inequities in perioperative care and support future strategies for risk stratification, resource allocation, and quality improvement in both public and private healthcare settings in Brazil.
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Contato de estudo
- Nome: Alexandre Weber, Md
- Número de telefone: 5554991902752
- E-mail: aleweber@hcpa.edu.br
Locais de estudo
-
-
Estado de Bahia
-
Salvador, Estado de Bahia, Brasil, 40110-060
- Hospital das Clínicas da Universidade Federal da Bahia
-
Contato:
- Liana MTA Azi, Md, PhD
- Número de telefone: 5571099901708
- E-mail: liana.araujo@ufba.br
-
-
Maranhão
-
São Luís, Maranhão, Brasil, 65060-645
- Hospital Sao Domingos
-
Contato:
- Plinio C Leal, Md, PhD
- Número de telefone: 5554991902752
- E-mail: pliniocunhaleal@hotmail.com
-
-
Paraná
-
Curitiba, Paraná, Brasil, 80050-370
- Hospital São Marcelino Champagnat
-
Contato:
- Maristela B Lopes, Md, PhD
- Número de telefone: 5541984923067
- E-mail: maristelabuenolopes@gmail.com
-
-
Rio Grande do Sul
-
Criciuma, Rio Grande do Sul, Brasil, 88.811-500
- Hospital São José
-
Contato:
- Eric B Lineburger, Md, PhD
- Número de telefone: 5554991902752
- E-mail: lineburger@unesc.net
-
Porto Alegre, Rio Grande do Sul, Brasil, 91350-200
- Hospital Nossa Senhora da Conceicao
-
Contato:
- Andre P Schmidt, Md, PhD
- Número de telefone: 5551996412212
- E-mail: apschmidt@hcpa.edu.br
-
Porto Alegre, Rio Grande do Sul, Brasil, 90410-000
- Hospital de Clinicas de Porto Alegre
-
Contato:
- Alexandre Weber, Md
- Número de telefone: 5554991902752
- E-mail: aleweber@hcpa.edu.br
-
-
São Paulo
-
São Paulo, São Paulo, Brasil, 04038-032
- Hospital Sao Paulo
-
Contato:
- Luiz FR Falcao, Md, PhD
- Número de telefone: 5554991902752
- E-mail: luizfernandofalcao@gmail.com
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Método de amostragem
População do estudo
Study participants will be selected from surgical patients treated at participating public and private hospitals in Brazil. The participating centers are Hospital São José in Criciúma, Santa Catarina; Hospital de Clínicas de Porto Alegre and Hospital Nossa Senhora da Conceição in Porto Alegre, Rio Grande do Sul; Hospital São Domingos in São Luís, Maranhão; Hospital Marcelino Champagnat in Curitiba, Paraná; Hospital São Paulo in São Paulo, São Paulo; and Hospital da Universidade Federal da Bahia in Salvador, Bahia.
These hospitals represent different geographic regions of Brazil and include both public and private healthcare settings.
Descrição
Inclusion Criteria:
- Patients aged 16 years or older.
- Patients who underwent an elective or urgent surgical procedure in an operating room at a participating hospital.
- Surgical procedure performed between January 1, 2024, and December 31, 2024.
Exclusion Criteria:
- Patients who underwent ophthalmologic surgery, diagnostic procedures only and procedures performed under local anesthesia only.
- Patients who underwent liver, lung or heart transplantation.
- Patients diagnosed with brain death who were organ donor candidates.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
|---|
|
2024 Surgical Patients
Patients aged 16 years or older who underwent elective or urgent surgical procedures in participating Brazilian hospitals between January 1 and December 31, 2024. Participating centers will include public and private hospitals. The cohort will be identified retrospectively from routinely collected hospital electronic records. There will be no study intervention and no change in patient care. The exposure of interest is socioeconomic deprivation, assessed using georeferenced area-level indices derived from each patient's residential address. Patients will be categorized according to levels of socioeconomic deprivation, and perioperative outcomes will be compared across these groups. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
30-day in-hospital postoperative mortality
Prazo: 30 days
|
Number of participants who died during the hospital stay within 30 days after the index surgical procedure.
Mortality will be assessed using routinely collected hospital electronic records, including the date of surgery, date of hospital discharge, and date of in-hospital death when applicable.
Participants discharged alive before 30 days will be considered alive for this outcome.
Participants who remain hospitalized beyond 30 days will be assessed up to postoperative day 30 only.
This is a binary outcome, reported as death or no death within 30 days after surgery.
|
30 days
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Admission to intensive care unit or regular ward after surgery
Prazo: Immediate postoperative destination
|
Admission to an intensive care unit or to a regular inpatient ward after the index surgical procedure.
Postoperative destination will be assessed using routinely collected hospital electronic records.
Intensive care unit admission will include admission to an intensive care unit or equivalent critical care unit immediately after surgery.
Regular inpatient ward admission will include admission to a standard hospital ward without intensive care support.
This is a categorical outcome, reported according to the first postoperative destination after surgery.
|
Immediate postoperative destination
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Luciana PC Stefani, Md, PhD, Hospital de Clinicas de Porto Alegre
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- 2025-0217
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .