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NCT Number: NCT07783204

ERAS Compliance and Nutritional Outcomes After Open Heart Surgery

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Bursa City Hospital

Bursa, Nilüfer, 16110, Turkey (Türkiye)

Location status: Recruiting

Location contact

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change in Nutritional Risk Screening 2002 Score

    Time frame: From the preoperative assessment to 48 hours after surgery

    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.

Secondary outcomes

  1. Change in Prognostic Nutritional Index

    Time frame: From the preoperative assessment to 48 hours after surgery

    The Prognostic Nutritional Index (PNI) will be calculated as: (10 × serum albumin [g/dL]) + (0.005 × total lymphocyte count [/mm³]). Higher scores indicate better nutritional and immunological status. The change from the preoperative value to the postoperative 48-hour value will be compared among the ERAS compliance cohorts.

  2. Incidence of Postoperative Complications

    Time frame: From surgery until hospital discharge, up to 30 days

    Number and percentage of participants who develop at least one postoperative complication, including infection, atrial fibrillation, acute kidney injury, or respiratory complications. Complications will be identified from routine clinical records and compared among the ERAS compliance cohorts.

Study contacts

Contact information is provided by the study sponsor or research team.

EMRE ULUSOY, MD

CONTACT

[email protected]

05379492799

Sponsors and collaborators

Lead sponsor

Bursa City Hospital

Other Gov

Registry information

Official study 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

Acronym: ERAS-CARD

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 24, 2026
Registry last updated
Aug 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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