Prospective Validation of ExCARE Model for 30-Day Postoperative Mortality

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07293377

Acronym

ExCARE-HNSC

Enrollment

3000

Registered

2025-12-19

Start date

2022-10-19

Completion date

2025-07-31

Last updated

2025-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Complications

Keywords

Surgical Procedures, Mortality, Postoperative Care, Risk Assessment, Surgery, Anesthesia, Perioperative Medicine, Postoperative Complications

Brief summary

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.

Detailed description

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
In-hospital mortality within 30 days post-surgery	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

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

Countries

Brazil

Outcome results