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Social DeprivationNCT07621211

Social Deprivation and Postoperative Mortality

An observational study of Social Deprivation, run by Hospital de Clinicas de Porto Alegre at 7 sites in Brazil.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 16 years and older
Conditions the study is for
Social Deprivation
How many people
45,000 participants
Where
7 sitesBrazil
Study dates
15 May 2026to Dec 2028
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: 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.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

7 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Alexandre Weber, Md contact

5554991902752

aleweber@hcpa.edu.br

7 sites in 1 country

Brazil7 sites, 7 recruiting
  • Hospital São José

    Criciuma, Rio Grande do Sul, 88.811-500

    Eric B Lineburger, Md, PhD, 5554991902752, lineburger@unesc.net

    Not yet recruiting
  • Hospital São Marcelino Champagnat

    Curitiba, Paraná, 80050-370

    Maristela B Lopes, Md, PhD, 5541984923067, maristelabuenolopes@gmail.com

    Recruiting
  • Hospital de Clínicas de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90410-000

    Alexandre Weber, Md, 5554991902752, aleweber@hcpa.edu.br

    Recruiting
  • Hospital Nossa Senhora da Conceição

    Porto Alegre, Rio Grande do Sul, 91350-200

    Andre P Schmidt, Md, PhD, 5551996412212, apschmidt@hcpa.edu.br

    Not yet recruiting
  • Hospital das Clínicas da Universidade Federal da Bahia

    Salvador, Estado de Bahia, 40110-060

    Liana MTA Azi, Md, PhD, 5571099901708, liana.araujo@ufba.br

    Not yet recruiting
  • Hospital São Domingos

    São Luís, Maranhão, 65060-645

    Plinio C Leal, Md, PhD, 5554991902752, pliniocunhaleal@hotmail.com

    Not yet recruiting
  • Hospital São Paulo

    São Paulo, São Paulo, 04038-032

    Luiz FR Falcao, Md, PhD, 5554991902752, luizfernandofalcao@gmail.com

    Not yet recruiting

Other trials in Brazil

About this study

Official title: 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.

Read more

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.

Read the detailed description

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.

Keywords
surgical procedures, social deprivation, risk factors

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07621211
Study groupRoleWhat they receive
2024 Surgical PatientsPatients 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 30-day in-hospital postoperative mortality

    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.

    Measured: 30 days

Secondary outcomes (1)
  1. Admission to intensive care unit or regular ward after surgery

    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.

    Measured: Immediate postoperative destination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jun 2026
  2. Study start15 May 2026
  3. Primary completionMay 2027 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
45,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07621211
Sponsor's protocol ID
2025-0217
Status last verified
Oct 2026
First submitted
27 May 2026
Last updated
26 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared. This is a retrospective study using routinely collected hospital data from multiple participating centers, including sensitive clinical information and residential address data used for georeferencing. Although the final analytical dataset will be de-identified, sharing individual-level data could pose confidentiality risks and may not be permitted under local ethics approvals and institutional data governance agreements. Study results will be reported only in aggregate form.

Questions about this trial

What is this clinical trial studying?

An observational study of Social Deprivation, run by Hospital de Clinicas de Porto Alegre at 7 sites in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Alexandre Weber, Md (5554991902752, aleweber@hcpa.edu.br), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

30-day in-hospital postoperative mortality (time frame: 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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