Postoperative ComplicationsExCARE-HNSCNCT07293377
Prospective Validation of ExCARE Model for 30-Day Postoperative Mortality
An observational study of Postoperative Complications, run by Hospital Nossa Senhora da Conceicao at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Complications
- How many people
- 3,000 participants
- Where
- 1 siteBrazil
- Study dates
- 19 Oct 2022to 31 Jul 2025
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Diagnostic procedures; Sedation-only or local anesthesia; Hepatic, pulmonary, or cardiac transplants; Brain-dead patients for organ donation.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital Nossa Senhora da Conceição
Porto Alegre, Rio Grande do Sul, 91350-200
About this study
Official title: 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.
Read the 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.
- Conditions
- Postoperative Complications
- Keywords
- Surgical Procedures, Mortality, Postoperative Care, Risk Assessment, Surgery, Anesthesia, Perioperative Medicine, Postoperative Complications
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 30 days
Secondary outcomes (1)
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)
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2025
- Study start19 Oct 2022
- Primary completion30 Jul 2025
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Postoperative ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (actual)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Hospital Nossa Senhora da Conceicao
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andre Prato Schmidt, Hospital Nossa Senhora da Conceicao
- Investigators
- Andre P. Schmidt, MD, PhD, Principal investigator, Hospital Nossa Senhora da Conceição
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07293377
- Sponsor's protocol ID
- 56209622.5.0000.5530
- Other IDs
- Secondary ID 1: 5.507.979
- Acronym
- ExCARE-HNSC
- Status last verified
- Dec 2025
- First submitted
- 7 Dec 2025
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 26966331Moonesinghe 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.
PubMed 24195875Protopapa 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.
PubMed 25388883Gutierrez 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.
PubMed 33127046Stefani 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.
PubMed 29084236
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Validation of a Risk Stratification Model for Mortality Up to 30 Days After Surgery
- ClinicalTrials.gov ID
- NCT07293377
- Acronym / sponsor ID
- ExCARE-HNSC / 56209622.5.0000.5530
- Conditions
- Postoperative Complications
- Keywords
- Surgical Procedures, Mortality, Postoperative Care, Risk Assessment, Surgery, Anesthesia, Perioperative Medicine, Postoperative Complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,000 participants (actual)
- Lead sponsor
- Hospital Nossa Senhora da ConceicaoUniversity, hospital or other
- Study start
- 19 Oct 2022 (actual)
- Primary completion
- 30 Jul 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 19 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Diagnostic procedures; Sedation-only or local anesthesia; Hepatic, pulmonary, or cardiac transplants; Brain-dead patients for organ donation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
1 secondary outcome
Performance of SORT model for 30-day mortality prediction
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Results publication: PubMed 26966331Weiser 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.
- Results publication: PubMed 24195875Moonesinghe 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.
- Results publication: PubMed 25388883Protopapa 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.
- Results publication: PubMed 33127046Gutierrez 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.
- Results publication: PubMed 29084236Stefani 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.
- Individual participant dataSharing planned: Undecided
Related trials for Postoperative Complications
Recruiting
Endo-SPONGE for Treatment of Anastomotic or Hartmann's Stump Leakages in Lower Pelvic Area
Anastomotic Leaks, Hartmanns Stump Leakage
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Not yet recruiting
Bispectral Index-Guided Propofol Sedation During Endoscopic Retrograde Cholangiopancreatography
Deep Sedation, Endoscopic Retrograde Cholangiopancreatography
Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
Cardiac Surgical Procedures, Blood Transfusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andre P. Schmidt, MD, PhD principal investigator
Hospital Nossa Senhora da Conceição
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Complications, run by Hospital Nossa Senhora da Conceicao at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In-hospital mortality within 30 days post-surgery (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07293377, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.