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

Not Applicable

• Conditions: Postoperative Complications; Patient Care Team

• Registration Number: NCT04187664
• Lead Sponsor: Hospital de Clinicas de Porto Alegre

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.

Study Timeline

• Study Start: 2019-01-30
• Study First Submitted: 2019-12-03
• Study First Submitted QC: 2019-12-04
• Study First Posted: 2019-12-05
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-25
• Last Update Posted: 2020-06-26
• Primary Completion: 2021-07-31
• Study Completion: 2021-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1720

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Mortality	30 days	In-hospital mortality within 30 days
Postoperative complications	7 days	Postoperative complications within 7-days defined by Post-operative Morbidity Survey (POMS) domains

Secondary Outcome Measures

Name	Time	Method
Unplanned intensive care unit (ICU) admission	30 days	Admission to ICU due to clinical deterioration within 30 days
Calls to rapid response team (RRT)	30 days	Number of calls to the RRT within 30 days
Surgical reintervention	30 days	Number of surgical reinterventions within 30 days
Length of stay (LOS)	6 months	Hospital length of stay (days)
High-sensitivity cardiac troponin levels	3 days	High-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 readmission	30 days	Hospital readmission within 30 days
Failure to rescue	30 days	Death after a treatable complication within 30 days

Trial Locations

Locations (1)

Hospital de Clinicas de Porto Alegre; 🇧🇷 Porto Alegre, Rio Grande Do Sul, Brazil