Skip to content

Extended Care in High-Risk Surgical Patient (EXCARE) Pathway in High-risk Surgical Population

Implementation of the Extended Care in High-Risk Surgical Patient (EXCARE) Pathway in High-risk Non-cardiac Surgical Population: Impact on Morbidity and 30-day Mortality

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04187664
Acronym
EXCARE
Enrollment
1720
Registered
2019-12-05
Start date
2019-01-30
Completion date
2021-07-31
Last updated
2020-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patient Care Team, Postoperative Complications

Keywords

failure to rescue, high-risk surgical patient

Brief summary

High risk surgical patients are subject to complications that impact rehabilitation time, overall mortality and costs. This project proposes the creation of a post-surgery care pathway called Extended Care in High-Risk Surgical Patients (EXCARE) in the form of coordinated multiprofessional actions dedicated to high-risk non-cardiac surgical patients with the aim of improving the postoperative outcomes. The proposed pathway comprises a range of actions that include individual patient-centered risk assessment by the Anaesthesia and Perioperative Medicine Service (SAMPE) Risk Model (30-day probability of death), specialized care in Post-Anesthetic and Intensive Care Units (ICU), and also in the surgical wards performed by the nursing, anesthesia, clinic and surgery teams. This is a quasi-experiment in which the clinical effectiveness of the extended care will be analyzed using a before-and-after comparison, the primary outcome being 30-day surgical mortality and postoperative complications at day 7 defined by PostOperative Morbidity Survey (POMS), a reliable and valid survey of short-term postoperative morbidity in major elective surgery. POMS domains evaluated are: pulmonary, infectious, renal, gastrointestinal, cardiovascular, neurological, haematological and wound complications. Secondary outcomes include 30-day mortality, hospital length of stay, number of Rapid Response Team calls, unplanned postoperative ICU admission, surgical reintervention, failure to rescue and hospital readmission. High-sensitive cardiac troponin (hs-cTn) levels will be measured before surgery and daily until 48 hours postoperatively to identify patients with myocardial injury (defined as any hs-cTn concentration greater than the 99th-percentile upper reference limit).

Detailed description

Study Strengths and Limitations: This is the first study to evaluate the implementation of surgical patient stratification using the SAMPE Risk Model, pioneering the creation of a multidisciplinary care pathway that involves nursing and medical teams, and can be consolidated as a future standard of assistance. The care bundle, using an objective risk communication tool, is expected to integrate the teams involved in the perioperative care, reducing the fragmentation of care and, consequently, postoperative complications. The study is designed to use historical controls (before and after) and is therefore inherently vulnerable to the biases of this design. It will be conducted in a single teaching hospital and referral centre that provides care to patients from across southern Brazil through the national unified health system centre, which can therefore limit its external validity.

Interventions

BEHAVIORALPostoperative Monitoring

Nursing and medical staff will monitor patients vital signs and clinical deterioration triggers twice as often as in previous ward care.

High-risk patients will have their high-sensitivity cardiac troponin tested preoperatively and daily for the first 48h postoperatively

Sponsors

Hospital de Clinicas de Porto Alegre
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

Quasi-experimental study, nonrandomized, pre-post intervention study

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age over 16 years; * Classified as high-risk by the SAMPE Risk Model (30-day mortality \>5%); * Underwent non-cardiac surgeries at the main operating room unit; * Referred postoperatively to the postanesthesia care unit or intensive care unit.

Exclusion criteria

* Patients undergoing procedures performed outside the operating room unit (outpatient, diagnostic, performed under local anesthesia); * Patients undergoing cardiac surgery with cardiopulmonary bypass and / or referred to the cardiac ICU postoperatively; * Patients undergoing organ transplantation; * Low-risk patients (classified as \<5% probability of death within 30 days by the SAMPE Risk Model).

Design outcomes

Primary

MeasureTime frameDescription
Mortality30 daysIn-hospital mortality within 30 days
Postoperative complications7 daysPostoperative complications within 7-days defined by Post-operative Morbidity Survey (POMS) domains

Secondary

MeasureTime frameDescription
Calls to rapid response team (RRT)30 daysNumber of calls to the RRT within 30 days
Surgical reintervention30 daysNumber of surgical reinterventions within 30 days
Length of stay (LOS)6 monthsHospital length of stay (days)
Failure to rescue30 daysDeath after a treatable complication within 30 days
High-sensitivity cardiac troponin levels3 daysHigh-sensitivity cardiac troponin (hs-cTn) elevation due to myocardial injury (defined as any hs-cTn concentration greater than the 99th-percentile upper reference limit.) 3 categories: * Acute myocardial injury due to myocardial infarction (requires at least 1 of the following: symptoms of myocardial ischemia, new ischemic electrocardiographic changes, new ischemic regional wall-motion abnormalities on cardiac imaging, and/or an acute coronary thrombus on coronary angiography) or nonischemic causes (documented nonischemic etiology); * Myocardial Injury After Noncardiac Surgery (MINS): myocardial injury caused by ischemia (that may or may not result in necrosis), has prognostic relevance and occurs during or within 30 days after noncardiac surgery. * Chronic myocardial injury: stable but elevated troponin.
Hospital readmission30 daysHospital readmission within 30 days
Unplanned intensive care unit (ICU) admission30 daysAdmission to ICU due to clinical deterioration within 30 days

Countries

Brazil

Contacts

Primary ContactLuciana Cadore Stefani, PhD
lpstefani@hcpa.edu.br+555133598226
Backup ContactAdriene Stahlschmidt, MD
adristah@gmail.com+555133598226

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026