An observational study in Postoperative Complications, sponsored by Hospital Nossa Senhora da Conceicao. Completed at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-19.
Sponsored by Hospital Nossa Senhora da Conceicao · Observational
This prospective observational cohort study aims to validate the ExCARE risk model, derived from four preoperative variables (age, ASA-PS classification, procedure urgency, and surgical magnitude), for predicting in-hospital mortality up to 30 days post-non-cardiac surgery in a Brazilian tertiary hospital. A secondary validation of the SORT (Surgical Outcome Risk Tool) model will also be performed for comparison. The study involves no interventions and focuses on risk stratification to improve perioperative care allocation.
Approximately 300 million major surgical procedures are performed worldwide annually, with postoperative complications increasing costs and mortality. This study addresses the need for better perioperative risk stratification in Brazil, following WHO recommendations for universal health coverage. The ExCARE model, developed from 13,581 patients at Hospital de Clínicas de Porto Alegre (HCPA), showed good discriminative capacity (repeated in a 7,254-patient validation cohort). This external prospective validation at Hospital Nossa Senhora da Conceição will assess its performance in a new setting. Patients are stratified into four risk classes: Class I (\<2% mortality), Class II (2-5%), Class III (5-10%), Class IV (>10%). Data will be analyzed using logistic regression, AUROC for discrimination, and Hosmer-Lemeshow test for calibration. Expected enrollment: 3,000 patients over 6 months.
1,332 studies on the registry are indexed under Postoperative Complications; 311 are open to participants now.
This study's enrollment of 3,000 is above the median of 251 across 537 observational studies indexed under Postoperative Complications.
Browse Postoperative Complications studies →Hospital Nossa Senhora da Conceicao is the lead sponsor of 21 studies on the registry; 5 are open to participants now.
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The study population for this prospective observational cohort study consists of adult patients aged over 18 years who are scheduled for elective, urgent, or emergency non-cardiac surgeries at the Hospital Nossa Senhora da Conceição in Porto Alegre, Brazil. Patients are recruited via convenience sampling from those routinely attending the hospital's surgical center and meeting the inclusion criteria.
Key inclusion criteria:
Age greater than 18 years. Undergoing elective, urgent, or emergency surgical procedures.
Key exclusion criteria:
Patients scheduled for diagnostic procedures. Procedures performed under sedation only or local anesthesia. Patients undergoing hepatic, pulmonary, or cardiac transplants. Patients diagnosed with brain death and undergoing organ donation. In cases of multiple surgical interventions during the same hospitalization, only the procedure of greatest magnitude is considered for outcome analysis.
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Exclusion Criteria:
Adult patients (\>18 years) undergoing elective, urgent, or emergency non-cardiac surgeries (excluding diagnostic procedures, sedation-only, local anesthesia, hepatic/pulmonary/cardiac transplants, or brain-dead organ donors). No intervention; routine care with prospective data collection.
In-hospital mortality within 30 days post-surgery
In-hospital mortality within 30 days post-surgery (Time Frame: 30 days; Measured as binary outcome: death \[1\] or discharge/alive \[0\]; Analyzed via ExCARE model probability and logistic regression)
Time frame: 30 days
Performance of SORT model for 30-day mortality prediction
Performance of SORT model for 30-day mortality prediction (Time Frame: 30 days; Compared to ExCARE via AUROC, calibration, and risk ratios)
Time frame: 30 days
Plan to share: Undecided
Ran from Oct 2022 to primary completion in Jul 2025, 33 months.
Of 276 non-industry observational studies under Postoperative Complications, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 40. This study's 33 months is above that.
Counting every sponsor, half of 281 studies reached it within 23 months; a quarter within 10 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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Hospital Nossa Senhora da Conceicao