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CompletedNCT07783204ERAS-CARDUpdated Sep 11, 2026

ERAS Compliance and Hospital Stay After Open Heart Surgery

An observational study in Cardiac Surgery, Nutritional Risk and Frailty, sponsored by Bursa City Hospital. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-09-11.

Sponsored by Bursa City Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
120
Ages
18 Years to 85 Years
Sex
All
01

Study summary

This prospective observational study will evaluate the association between compliance with an Enhanced Recovery After Surgery (ERAS) protocol and length of hospital stay in 120 adults undergoing elective open heart surgery. Secondary outcomes will include nutritional status, postoperative complications, intensive care unit stay, 30-day readmission, and mortality.

Read the detailed description

This single-center, prospective observational study will include 120 adults undergoing elective open heart surgery. Participants will receive routine perioperative care without any research-specific intervention. ERAS compliance will be calculated and classified as high (≥80%), moderate (60-79%), or low (\<60%). The primary outcome will be length of hospital stay. Secondary outcomes will include changes in NRS-2002 and PNI, postoperative complications, intensive care unit stay, 30-day readmission, and mortality.

02

Conditions studied

  • Cardiac Surgery
  • Nutritional Risk
  • Frailty

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Keywords

  • Enhanced Recovery After Surgery
  • ERAS Compliance
  • Prognostic Nutritional Index
  • NRS-2002
  • Clinical Frailty Scale
  • Open Heart Surgery
03

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

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
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
120 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • OtherERAS Protocol Compliance Assessment

    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.

05

What researchers measure

Primary outcomes

  1. Length of Hospital Stay

    Length of hospital stay will be defined as the number of calendar days from the date of surgery to hospital discharge. The duration will be calculated for each participant and compared among the high, moderate, and low ERAS compliance cohorts. A shorter hospital stay indicates earlier postoperative recovery and discharge.

    Time frame: From the date of surgery to hospital discharge, up to 60 days

Secondary outcomes

  1. Change in Prognostic Nutritional Index

    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 the preoperative assessment to 48 hours after surgery

  2. Incidence of Postoperative Complications

    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.

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

  3. 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.

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

06

Study locations

1 site
  • Bursa City Hospital
    Bursa, Nilüfer 16110, Turkey (Türkiye)
07

References and documents

Individual participant data

Plan to share: No — Individual participant data will not be publicly shared because the informed consent and ethics approval do not include public sharing of participant-level data. Deidentified aggregate study results may be reported in scientific publications and presentations.

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07783204
Lead sponsor
Bursa City Hospital
Responsible party
Emre Ulusoy (MD, Bursa City Hospital) — Principal investigator
First posted
Aug 24, 2026
Start date
Jun 1, 2026
Primary completion
Sep 9, 2026
Completion
Sep 9, 2026
Last update
Sep 11, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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