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

NCT04187664 | Unknown

• 1 other identifier: 2019-0066
• Study Type: interventional
• Target: 1,720
• Locations: 1 country
• Sites: 1

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).

Conditions

Postoperative Complications; Patient Care Team

Keywords

failure to rescue; high-risk surgical patient

Outcome Measures

Primary Outcomes (2)

• Mortality

  In-hospital mortality within 30 days

  30 days

• Postoperative complications

  Postoperative complications within 7-days defined by Post-operative Morbidity Survey (POMS) domains

  7 days

Secondary Outcomes (7)

• Length of stay (LOS)

  6 months

• Unplanned intensive care unit (ICU) admission

  30 days

• Calls to rapid response team (RRT)

  30 days

• Surgical reintervention

  30 days

• Hospital readmission

  30 days

Study Arms (1)

EXCARE Pathway Group

EXPERIMENTAL

The proposed pathway comprises a range of actions that include individual patient-centered risk assessment by the SAMPE Risk Model (30-day probability of death), specialized care in Post-Anesthetic and Intensive Care Units, and also in the surgical wards performed by the nursing, anesthesia, clinic and surgery teams.

Behavioral: Postoperative Monitoring; Diagnostic Test: High-sensitivity cardiac troponin testing

Interventions

Postoperative Monitoring BEHAVIORAL

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

EXCARE Pathway Group

High-sensitivity cardiac troponin testing DIAGNOSTIC_TEST

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

EXCARE Pathway Group

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (1)

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035007, Brazil

RECRUITING

Related Publications (7)

• Stefani LC, Gutierrez CS, Castro SMJ, Zimmer RL, Diehl FP, Meyer LE, Caumo W. Derivation and validation of a preoperative risk model for postoperative mortality (SAMPE model): An approach to care stratification. PLoS One. 2017 Oct 30;12(10):e0187122. doi: 10.1371/journal.pone.0187122. eCollection 2017.

  PMID: 29084236 BACKGROUND

• Writing Committee for the VISION Study Investigators; Devereaux PJ, Biccard BM, Sigamani A, Xavier D, Chan MTV, Srinathan SK, Walsh M, Abraham V, Pearse R, Wang CY, Sessler DI, Kurz A, Szczeklik W, Berwanger O, Villar JC, Malaga G, Garg AX, Chow CK, Ackland G, Patel A, Borges FK, Belley-Cote EP, Duceppe E, Spence J, Tandon V, Williams C, Sapsford RJ, Polanczyk CA, Tiboni M, Alonso-Coello P, Faruqui A, Heels-Ansdell D, Lamy A, Whitlock R, LeManach Y, Roshanov PS, McGillion M, Kavsak P, McQueen MJ, Thabane L, Rodseth RN, Buse GAL, Bhandari M, Garutti I, Jacka MJ, Schunemann HJ, Cortes OL, Coriat P, Dvirnik N, Botto F, Pettit S, Jaffe AS, Guyatt GH. Association of Postoperative High-Sensitivity Troponin Levels With Myocardial Injury and 30-Day Mortality Among Patients Undergoing Noncardiac Surgery. JAMA. 2017 Apr 25;317(16):1642-1651. doi: 10.1001/jama.2017.4360.

  PMID: 28444280 BACKGROUND

• Pearse RM, Moreno RP, Bauer P, Pelosi P, Metnitz P, Spies C, Vallet B, Vincent JL, Hoeft A, Rhodes A; European Surgical Outcomes Study (EuSOS) group for the Trials groups of the European Society of Intensive Care Medicine and the European Society of Anaesthesiology. Mortality after surgery in Europe: a 7 day cohort study. Lancet. 2012 Sep 22;380(9847):1059-65. doi: 10.1016/S0140-6736(12)61148-9.

  PMID: 22998715 BACKGROUND

• Ferraris VA, Bolanos M, Martin JT, Mahan A, Saha SP. Identification of patients with postoperative complications who are at risk for failure to rescue. JAMA Surg. 2014 Nov;149(11):1103-8. doi: 10.1001/jamasurg.2014.1338.

  PMID: 25188264 BACKGROUND

• Bennett-Guerrero E, Welsby I, Dunn TJ, Young LR, Wahl TA, Diers TL, Phillips-Bute BG, Newman MF, Mythen MG. The use of a postoperative morbidity survey to evaluate patients with prolonged hospitalization after routine, moderate-risk, elective surgery. Anesth Analg. 1999 Aug;89(2):514-9. doi: 10.1097/00000539-199908000-00050.

  PMID: 10439777 BACKGROUND

• Stahlschmidt A, Passos SC, Dornelles DD, Polanczyk C, Gutierrez CS, Minuzzi RR, Castro SMJ, Stefani LC; and the Ex-Care Collaborative. 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. Can J Anaesth. 2023 Nov;70(11):1776-1788. doi: 10.1007/s12630-023-02558-4. Epub 2023 Oct 18.

  PMID: 37853279 DERIVED

• Stahlschmidt A, Passos SC, Cardoso GR, Schuh GJ, Gutierrez CS, Castro SMJ, Caumo W, Pearse RM; Ex-Care collaborative; Stefani LC. Enhanced peri-operative care to improve outcomes for high-risk surgical patients in Brazil: a single-centre before-and-after cohort study. Anaesthesia. 2022 Apr;77(4):416-427. doi: 10.1111/anae.15671. Epub 2022 Feb 15.

  PMID: 35167136 DERIVED

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Luciana Cadore Stefani, PhD

  Hospital de Clinicas de Porto Alegre

  STUDY DIRECTOR

Central Study Contacts

Luciana Cadore Stefani, PhD

CONTACT

+555133598226; lpstefani@hcpa.edu.br

Adriene Stahlschmidt, MD

CONTACT

+555133598226; adristah@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Quasi-experimental study, nonrandomized, pre-post intervention study

Study Record Dates

• First Submitted: December 3, 2019
• First Posted: December 5, 2019
• Study Start: January 30, 2019
• Primary Completion: July 31, 2021
• Study Completion: July 31, 2021
• Last Updated: June 26, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)