NCT05225272

Brief Summary

In 2019, the Enhanced Recovery After Surgery (ERAS) Society published recommendations for perioperative care in cardiac surgery. ERAS recommendations included 22 perioperative interventions that may be part of any cardiac Enhanced Recovery Program (ERP). Since that publication, additional perioperative interventions were reported and may be added to a cardiac ERP. Studies on cardiac ERPs report variable benefits on postoperative recovery including lower pain scores, lower opioid consumption and related side effects, shorter intensive care unit and hospital discharge times. At the "Centre Hospitalier de l'Université de Montréal" (CHUM), although most care takers are aware of ERAS recommendations for cardiac surgery patients, adherence to these recommendations is heterogeneous and a cardiac ERP was never implemented.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for all trials

Timeline
12mo left

Started Sep 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 26, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 4, 2022

Completed
4.6 years until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

September 18, 2025

Status Verified

September 1, 2025

Enrollment Period

1 year

First QC Date

January 26, 2022

Last Update Submit

September 12, 2025

Conditions

Disorder; Heart, Functional, Postoperative, Cardiac Surgery

Keywords

On-pump cardiac surgeryEnhanced recovery after surgery

Outcome Measures

Primary Outcomes (1)

  • Time before patient extubation

    Time elapsed between final wound dressing and removal of the endotracheal tube, before and after implementation of the cardiac ERP.

    From the end of the surgery to extubation, up to 1 week

Secondary Outcomes (11)

  • Incidence of reintubation

    Up to 24 hours after extubation

  • Acute pain scores using the Numerical Rating Scale (NRS)

    8, 16, 24 and 48 hours after surgery

  • Opioid consumption

    8, 16, 24 and 48 hours after surgery

  • Opioid side effects

    8, 16, 24 and 48 hours after surgery

  • Incidence of delirium in the intensive care unit (ICU) using the ICDSC score

    Up to 7 days after surgery or ICU discharge, whichever comes first

  • +6 more secondary outcomes

Study Arms (1)

Patients undergoing on-pump cardiac surgery

The investigators aim to conduct a bidirectional (prospective and retrospective) observational, cohort study including on-pump cardiac surgery patients.

Other: Enhanced Recovery Program for on-pump cardiac surgery

Interventions

Enhanced Recovery Program for on-pump cardiac surgeryOTHER

Implementation of a Enhanced Recovery Program for on-pump cardiac surgery patients

Patients undergoing on-pump cardiac surgery

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The investigators aim to conduct a bidirectional cohort study including on-pump cardiac surgery patients. This study will take place at the Centre Hospitalier de l'Université de Montréal (CHUM).

You may qualify if:

  • On-pump cardiac surgery

You may not qualify if:

  • Left Ventricular Ejection Fraction (LVEF) lower than 50%
  • Glomerular filtration rate lower than 50 mL/min
  • Significant pulmonary hypertension (systolic pulmonary artery pressure higher than 65 mmHg)
  • Presence of Intra-aortic balloon pump therapy before surgery
  • Endocarditis surgery
  • An estimated mortality over 8% based on the EuroSCORE II
  • Patients who already had cardiac surgery in the past.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, H2X 0A9, Canada

Location

Study Officials

  • Alex Moore, MD, FRCPC

    Centre hospitalier de l'Université de Montréal (CHUM)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alex Moore, MD, FRCPC

CONTACT

514-890-8000alex.moore@umontreal.ca

Julie Desroches, PhD

CONTACT

514-890-8000anesthesie.recherche.chum@ssss.gouv.qc.ca

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2022

First Posted

February 4, 2022

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

September 18, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)