Prospective Validation of ExCARE Model for 30-Day Postoperative Mortality

NCT07293377 | Completed

• 2 other identifiers: 56209622.5.0000.5530Secondary ID 1: 5.507.979
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Complications

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Performance of SORT model for 30-day mortality prediction

  30 days

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Hospital Nossa Senhora da Conceicao: lead

Study Sites (1)

Hospital Nossa Senhora da Conceição

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

Location

Related Publications (5)

• 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.

  PMID: 26966331 RESULT

• 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.

  PMID: 24195875 RESULT

• 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.

  PMID: 25388883 RESULT

• 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.

  PMID: 33127046 RESULT

• 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.

  PMID: 29084236 RESULT

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Andre P. Schmidt, MD, PhD

  Hospital Nossa Senhora da Conceição

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 7, 2025
• First Posted: December 19, 2025
• Study Start: October 19, 2022
• Primary Completion: July 30, 2025
• Study Completion: July 31, 2025
• Last Updated: December 19, 2025

Record last verified: 2025-12

Locations

BR (1)