NCT05796024

Brief Summary

The goal of this study is to develop a novel surgical risk stratification tool designed to adults operated in Brazil. The main question it aims to answer is: •Is the Extended Care (Ex-Care) II model a good tool to assess the risk of death among patients operated in Brazilian hospitals within 30 days after surgery? Information of patients undergoing surgery in the participating hospitals over a period of 24 months will be analyzed to evaluate the relationship of some patients characteristics (called predictors) with the study outcome (probability of death). The sample will be divided in two groups. The first, called derivation sample, will be used for the development of the Ex-Care II model. The second, called validation sample, will evaluate the performance of this new model.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
107,372

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2019

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 21, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 3, 2023

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2023

Completed
Last Updated

April 3, 2023

Status Verified

March 1, 2023

Enrollment Period

4 years

First QC Date

March 21, 2023

Last Update Submit

March 21, 2023

Conditions

Postoperative Complications

Keywords

risk assessementvalidation studypostoperativemortality

Outcome Measures

Primary Outcomes (1)

  • Develop and validate a model for predicting the risk of in-hospital death within 30 days postoperatively, from a sample composed of patients operated in Brazil

    From four predictors collected preoperatively, the developed model will be able to estimate the probability of in-hospital death of patients undergoing surgery in Brazilian hospitals. For the creation of this tool, multilevel logistic regression will be made with hospital as a random effect

    Surgery day up to 30 days postoperatively

Secondary Outcomes (1)

  • Develop smartphone application contemplating the new model developed

    Preoperative

Study Arms (2)

Derivation Cohort

The derivation cohort will correspond to approximately 70% of the total sample to be analyzed in the study. The Ex-Care II risk model will build upon it. It is composed of patients operated in the participating institutions.

Validation Cohort

Composed of the remaining 30% of the sample. It will be used for the external validation of the Ex-Care II model

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients aged 16 years or older undergoing surgery in hospitals in different regions of Brazil

You may qualify if:

  • Patients from 16 years of age undergoing elective, urgent or emergency surgeries in the hospitals participating in the study

You may not qualify if:

  • Diagnostic procedures, with sedation only or with local anesthesia
  • Patients undergoing liver, pulmonary and/or cardiac transplant surgery, as well as those diagnosed with brain death submitted to organ donation
  • In the event that the patient undergoes more than one surgical intervention in the same hospitalization, only the major procedure will be considered for the purpose of denouement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 91360390, Brazil

Location

Related Publications (2)

  • Passos SC, Stahlschmidt A, Blanco J, Spader ML, Brandao RB, Castro SMJ, Gutierrez CS, Silva Neto PCD, Stefani LPC. Derivation and validation of a national multicenter mortality risk stratification model - the ExCare model: a study protocol. Braz J Anesthesiol. 2022 May-Jun;72(3):316-321. doi: 10.1016/j.bjane.2021.07.003. Epub 2021 Jul 26.

    PMID: 34324938RESULT

  • Passos SC, de Jezus Castro SM, Stahlschmidt A, da Silva Neto PC, Irigon Pereira PJ, da Cunha Leal P, Lopes MB, Dos Reis Falcao LF, de Azevedo VLF, Lineburger EB, Mendes FF, Vilela RM, de Araujo Azi LMT, Antunes FD, Braz LG, Stefani LC. Development and validation of the Ex-Care BR model: a multicentre initiative for identifying Brazilian surgical patients at risk of 30-day in-hospital mortality. Br J Anaesth. 2024 Jul;133(1):125-134. doi: 10.1016/j.bja.2024.04.001. Epub 2024 May 10.

    PMID: 38729814DERIVED

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Luciana C Stefani, PhD

    Hospital de Clínicas de Porto Alegre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2023

First Posted

April 3, 2023

Study Start

January 2, 2019

Primary Completion

December 31, 2022

Study Completion

November 30, 2023

Last Updated

April 3, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)