ERAS Compliance and Nutritional Outcomes After Open Heart Surgery | NCT07783204 | Trialant

RecruitingObservationalUpdated Aug 24, 2026

ERAS Compliance and Nutritional Outcomes After Open Heart Surgery

Prospective Evaluation of the Association Between ERAS Protocol Compliance and Postoperative Nutritional Risk, Prognostic Nutritional Index, Frailty Status, and Surgical Risk Scores in Patients Undergoing Open Heart Surgery

Overview

Key facts that identify this study and show where it stands today.

ClinicalTrials.gov ID: NCT07783204
Lead Sponsor: Bursa City HospitalOTHER_GOV
Overall Status: Recruiting
Study Type: Observational
Enrollment: 120Estimated
Last Update Posted: Aug 24, 2026Actual
Start Date: Jun 1, 2026Actual
Primary Completion Date: Sep 2, 2026Estimated
Completion Date: Sep 30, 2026Estimated

Description

What the study is about and why it is being run, in the researchers' own words.

Official Title: Prospective Evaluation of the Association Between ERAS Protocol Compliance and Postoperative Nutritional Risk, Prognostic Nutritional Index, Frailty Status, and Surgical Risk Scores in Patients Undergoing Open Heart Surgery
Brief Summary: This prospective observational cohort study will evaluate the association between compliance with an Enhanced Recovery After Surgery (ERAS) protocol and postoperative nutritional and clinical outcomes in adult patients undergoing elective open heart surgery through median sternotomy. No research-specific treatment or intervention will be assigned.

Compliance with preoperative, intraoperative, and postoperative ERAS components will be recorded for each participant. An overall ERAS compliance percentage will be calculated, and participants will be classified as having high (≥80%), moderate (60-79%), or low (<60%) compliance.

Nutritional status will be assessed using the Nutritional Risk Screening 2002 (NRS-2002) score and the Prognostic Nutritional Index (PNI) before surgery and 48 hours after surgery. Frailty will be assessed preoperatively using the Clinical Frailty Scale, and surgical risk will be estimated using EuroSCORE II. Postoperative complications, intensive care unit and hospital length of stay, and readmission within 30 days will also be recorded.

Conditions

The medical conditions and diseases this study investigates.

Cardiac Surgery
Nutritional Risk
Frailty

Interventions

The treatments and procedures being evaluated in this study.

ERAS Protocol Compliance Assessment

Participation

Who can join this study and the criteria used to decide.

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Eligibility Criteria: Inclusion Criteria:

Aged 18 to 85 years

Scheduled to undergo elective open heart surgery through median sternotomy under general anesthesia

Able to provide written informed consent

Exclusion Criteria:

Emergency cardiac surgery

Preoperative total parenteral nutrition

End-stage renal disease or severe hepatic failure

Uncontrolled metabolic disease, including uncontrolled diabetes mellitus or hypertension

Active infection

Cognitive or mental impairment preventing valid informed consent

Pregnancy, suspected pregnancy, or breastfeeding

Design

How the study is designed and how its participant groups are organized.

Observational Model: Cohort
Time Perspective: Prospective

Contacts

The people to reach with questions about this study or how to join it.

EMRE ULUSOY, MDContact

emreulusoy36@gmail.com05379492799

Locations

Where the study is run and whether each site is currently recruiting.

Bursa City HospitalRecruiting

Bursa, Nilüfer 16110, Turkey (Türkiye)

Collaborators

The organizations and people involved in this study.

Lead Sponsor: Bursa City HospitalOTHER_GOV

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Other registered studies that closely resemble this one.

Detailed Description

Patients undergoing open heart surgery are at increased risk of postoperative complications and delayed recovery because of surgical trauma, cardiopulmonary bypass-related inflammation, metabolic stress, and temporary organ dysfunction. ERAS protocols use evidence-based multimodal perioperative care components to reduce surgical stress and improve recovery.

This single-center, prospective observational cohort study will include 120 adult patients undergoing elective open heart surgery through median sternotomy under general anesthesia. All participants will receive routine perioperative care according to the institutional cardiac surgery ERAS protocol. The study will not assign participants to an intervention, alter routine treatment, or require any additional invasive procedure.

Compliance with predefined ERAS components will be assessed during the preoperative, intraoperative, and postoperative periods. Each implemented component will receive one point, and each non-implemented component will receive zero points. The number of implemented components will be divided by the total number of applicable components to calculate an overall ERAS compliance percentage. Participants will subsequently be categorized into high-compliance (≥80%), moderate-compliance (60-79%), and low-compliance (<60%) groups.

Nutritional risk will be evaluated using NRS-2002 before surgery and at postoperative 48 hours. PNI will be calculated at the same time points using serum albumin concentration and total lymphocyte count. Frailty will be evaluated preoperatively using the Clinical Frailty Scale, and operative mortality risk will be estimated using EuroSCORE II.

The study will examine changes in nutritional risk and PNI and their associations with ERAS compliance. Postoperative complications, intensive care unit length of stay, total hospital length of stay, and readmission within 30 days will also be recorded. Relationships among ERAS compliance, nutritional parameters, frailty, surgical risk, and postoperative clinical outcomes will be analyzed.