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Prospective Validation of ExCARE Model for 30-Day Postoperative Mortality

NCT ID: NCT07293377

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-19

Study Completion Date

2025-07-31

Brief Summary

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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

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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.

Conditions

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Postoperative Complications

Keywords

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Nossa Senhora da Conceicao

OTHER

Sponsor Role lead

Responsible Party

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Andre Prato Schmidt

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andre P. Schmidt, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Nossa Senhora da Conceição

Locations

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Hospital Nossa Senhora da Conceição

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type RESULT
PMID: 26966331 (View on PubMed)

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.

Reference Type RESULT
PMID: 24195875 (View on PubMed)

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.

Reference Type RESULT
PMID: 25388883 (View on PubMed)

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.

Reference Type RESULT
PMID: 33127046 (View on PubMed)

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.

Reference Type RESULT
PMID: 29084236 (View on PubMed)

Other Identifiers

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56209622.5.0000.5530

Identifier Type: -

Identifier Source: org_study_id

Secondary ID 1: 5.507.979

Identifier Type: OTHER

Identifier Source: secondary_id