Bursa City Hospital
Bursa, Nilüfer, 16110, Turkey (Türkiye)
Location status: Recruiting
NCT Number: NCT07783204
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.
Interested in participating?
Request Info18 year–85 year
All sexes
Observational
Bursa, Nilüfer, 16110, Turkey (Türkiye)
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
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.
Contact information is provided by the study sponsor or research team.
Bursa City Hospital
Other Gov
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
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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