Prospective Validation of ExCARE Model for 30-Day Postoperative Mortality (ExCARE-HNSC)

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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Complications

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.

• Study Type: Observational
• Enrollment (Actual): 3000

Contacts and Locations

Study Locations

• Brazil
  • Rio Grande do Sul
    • Porto Alegre, Rio Grande do Sul, Brazil, 91350-200
      • Hospital Nossa Senhora da Conceicao

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Surgical Patients Cohort; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	30 days

Collaborators and Investigators

• Sponsor: Hospital Nossa Senhora da Conceicao
• Investigators: Principal Investigator: Andre P. Schmidt, MD, PhD, Hospital Nossa Senhora da Conceicao

Publications and helpful links

General Publications

• Protopapa KL, Simpson JC, Smith NC, Moonesinghe SR. Development and validation of the Surgical Outcome Risk Tool (SORT). Br J Surg. 2014 Dec;101(13):1774-83. doi: 10.1002/bjs.9638.
• Weiser TG, Haynes AB, Molina G, Lipsitz SR, Esquivel MM, Uribe-Leitz T, Fu R, Azad T, Chao TE, Berry WR, Gawande AA. Size and distribution of the global volume of surgery in 2012. Bull World Health Organ. 2016 Mar 1;94(3):201-209F. doi: 10.2471/BLT.15.159293.
• Moonesinghe SR, Mythen MG, Das P, Rowan KM, Grocott MP. Risk stratification tools for predicting morbidity and mortality in adult patients undergoing major surgery: qualitative systematic review. Anesthesiology. 2013 Oct;119(4):959-81. doi: 10.1097/ALN.0b013e3182a4e94d.
• Gutierrez CS, Passos SC, Castro SMJ, Okabayashi LSM, Berto ML, Lorenzen MB, Caumo W, Stefani LC. Few and feasible preoperative variables can identify high-risk surgical patients: derivation and validation of the Ex-Care risk model. Br J Anaesth. 2021 Feb;126(2):525-532. doi: 10.1016/j.bja.2020.09.036. Epub 2020 Oct 27.
• Stefani LC, Gutierrez CS, Castro SMJ, Zimmer RL, Diehl FP, Meyer LE, Caumo W. Derivation and validation of a preoperative risk model for postoperative mortality (SAMPE model): An approach to care stratification. PLoS One. 2017 Oct 30;12(10):e0187122. doi: 10.1371/journal.pone.0187122. eCollection 2017.

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2022
• Primary Completion (Actual): July 30, 2025
• Study Completion (Actual): July 31, 2025

Study Registration Dates

• First Submitted: December 7, 2025
• First Submitted That Met QC Criteria: December 7, 2025
• First Posted (Actual): December 19, 2025

Study Record Updates

• Last Update Posted (Actual): December 19, 2025
• Last Update Submitted That Met QC Criteria: December 7, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Surgery; Mortality; Anesthesia; Risk Assessment; Perioperative Medicine; Postoperative Complications; Postoperative Care; Surgical Procedures
• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Signs and Symptoms; Postoperative Complications
• Other Study ID Numbers: 56209622.5.0000.5530; Secondary ID 1: 5.507.979 (Other Identifier: Hospital Nossa Senhora da Conceicao)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No