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

NCT04187664 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1720

Last updated 2020-06-26

No results posted yet for this study

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).

Conditions

  • Postoperative Complications
  • Patient Care Team

Interventions

BEHAVIORAL

Postoperative Monitoring

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

DIAGNOSTIC_TEST

High-sensitivity cardiac troponin testing

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

Sponsors & Collaborators

  • Hospital de Clinicas de Porto Alegre

    lead OTHER

Principal Investigators

  • Luciana Cadore Stefani, PhD · Hospital de Clinicas de Porto Alegre

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-30
Primary Completion
2021-07-31
Completion
2021-07-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04187664 on ClinicalTrials.gov