NCT04187664: EXCARE

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

Status unknown NA Last updated 26 June 2020

What this trial tests

NA trial testing Postoperative Monitoring in Postoperative Complications in 1,720 participants. Status unknown.

Timeline

30 January 2019

Primary endpoint
31 July 2021

31 July 2021

Quick facts

Lead sponsor	Hospital de Clinicas de Porto Alegre
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	supportive care
Enrollment	1,720
Start date	30 January 2019
Primary completion	31 July 2021
Estimated completion	31 July 2021
Sites	1 location across Brazil

Drugs / interventions tested

• Postoperative Monitoring
• High-sensitivity cardiac troponin testing

Conditions studied

• Postoperative Complications — all drugs for Postoperative Complications →
• Patient Care Team — all drugs for Patient Care Team →

Sponsor

Hospital de Clinicas de Porto Alegre

Who can join

16 and older, any sex, with Postoperative Complications or Patient Care Team. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Development of a recovery-room discharge checklist (SAMPE checklist) for safe handover and its comparison with Aldrete and White scoring systems.
   Prates A, Colognese B, Caumo W, Stefani LC. · · 2022 · cited 8× · PMID 34324931 · DOI 10.1016/j.bjane.2021.07.004
2. The impact of the incorporation of a feasible postoperative mortality model at the Post-Anaesthestic Care Unit (PACU) on postoperative clinical deterioration: A pragmatic trial with 5,353 patients.
   de Souza Gutierrez C, Bottega K, de Jezus Castro SM, Gravina GL, et al · · 2021 · cited 4× · PMID 34780486 · DOI 10.1371/journal.pone.0257941
3. Postoperative intensive care allocation and mortality in high-risk surgical patients: evidence from a low- and middle-income country cohort.
   Stahlschmidt A, Passos SC, Cardoso GR, Schuh GJ, et al · · 2024 · cited 3× · PMID 38789003 · DOI 10.1016/j.bjane.2024.844517
4. Troponin elevation as a marker of short deterioration and one-year death in a high-risk surgical patient cohort in a low and middle income country setting: a postoperative approach to increase surveillance.
   Stahlschmidt A, Passos SC, Dornelles DD, Polanczyk C, et al · · 2023 · cited 1× · PMID 37853279 · DOI 10.1007/s12630-023-02558-4