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NCT Number: NCT07293377

Prospective Validation of ExCARE Model for 30-Day Postoperative Mortality

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.

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Key information

Conditions

Postoperative Complications Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Nossa Senhora da Conceição

Porto Alegre, Rio Grande do Sul, 91350-200, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age >18 years; Scheduled for elective, urgent, or emergency surgeries at Hospital Nossa Senhora da Conceição; For multiple surgeries in one admission, only the major procedure considered.

Exclusion criteria

  • Diagnostic procedures; Sedation-only or local anesthesia; Hepatic, pulmonary, or cardiac transplants; Brain-dead patients for organ donation.

Treatment and study plan

Primary outcomes

  1. In-hospital mortality within 30 days post-surgery

    Time frame: 30 days

    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)

Secondary outcomes

  1. Performance of SORT model for 30-day mortality prediction

    Time frame: 30 days

    Performance of SORT model for 30-day mortality prediction (Time Frame: 30 days; Compared to ExCARE via AUROC, calibration, and risk ratios)

Sponsors and collaborators

Lead sponsor

Hospital Nossa Senhora da Conceicao

Other

Registry information

Official study title

Prospective Validation of a Risk Stratification Model for Mortality Up to 30 Days After Surgery

Acronym: ExCARE-HNSC

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Dec 19, 2025
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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