ERAS Compliance and Nutritional Outcomes After Open Heart Surgery

NCT07783204 | Recruiting

• 1 other identifier: EU01
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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

Cardiac Surgery; Nutritional Risk; Frailty

Keywords

Enhanced Recovery After Surgery; ERAS Compliance; Prognostic Nutritional Index; NRS-2002; Clinical Frailty Scale; Open Heart Surgery

Outcome Measures

Primary Outcomes (1)

• Change in Nutritional Risk Screening 2002 Score

  Nutritional risk will be assessed using the Nutritional Risk Screening 2002 (NRS-2002). The score incorporates impaired nutritional status, disease severity, and an additional point for participants aged 70 years or older. Total scores range from 0 to 7, with higher scores indicating greater nutritional risk. A score of 3 or higher indicates the presence of nutritional risk. The primary outcome is the change in NRS-2002 score from the preoperative assessment to 48 hours after surgery. Changes will be compared among the high, moderate, and low ERAS compliance cohorts.

  From the preoperative assessment to 48 hours after surgery

Secondary Outcomes (2)

• Change in Prognostic Nutritional Index

  From the preoperative assessment to 48 hours after surgery

• Incidence of Postoperative Complications

  From surgery until hospital discharge, up to 30 days

Study Arms (3)

High ERAS Compliance

Participants with an overall ERAS protocol compliance rate of 80% or higher. Group classification will be based on the observed proportion of applicable preoperative, intraoperative, and postoperative ERAS components implemented during routine clinical care.

Other: ERAS Protocol Compliance Assessment

Moderate ERAS Compliance

Participants with an overall ERAS protocol compliance rate between 60% and 79%. Group classification will be based on the observed proportion of applicable preoperative, intraoperative, and postoperative ERAS components implemented during routine clinical care.

Other: ERAS Protocol Compliance Assessment

Low ERAS Compliance

Participants with an overall ERAS protocol compliance rate below 60%. Group classification will be based on the observed proportion of applicable preoperative, intraoperative, and postoperative ERAS components implemented during routine clinical care.

Other: ERAS Protocol Compliance Assessment

Interventions

ERAS Protocol Compliance Assessment OTHER

Compliance with applicable preoperative, intraoperative, and postoperative ERAS components will be recorded without altering routine clinical care. Each implemented component will be scored as 1 and each non-implemented component as 0. Overall compliance will be calculated as the percentage of applicable components implemented. No study-specific therapeutic intervention will be assigned.

High ERAS Compliance; Low ERAS Compliance; Moderate ERAS Compliance

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of consecutive adult patients aged 18 to 85 years who are scheduled to undergo elective open heart surgery through median sternotomy at Bursa City Hospital. Eligible participants will receive routine perioperative care according to the institutional cardiac surgery ERAS protocol. Participants will be observed prospectively and categorized according to their overall ERAS compliance rate as high (≥80%), moderate (60-79%), or low (\<60%) compliance.

You may qualify if:

• Aged 18 to 85 years
• Scheduled to undergo elective open heart surgery through median sternotomy under general anesthesia
• Able to provide written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Bursa City Hospital: lead

Study Sites (1)

Bursa City Hospital

Bursa, Nilüfer, 16110, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

EMRE ULUSOY, MD

CONTACT

05379492799; emreulusoy36@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 20, 2026
• First Posted: August 24, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): September 2, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: August 24, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)