Cardiac SurgeryERAS-CARDNCT07783204
ERAS Compliance and Hospital Stay After Open Heart Surgery
An observational study of Cardiac Surgery and Nutritional Risk, run by Bursa City Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Cardiac Surgery, Nutritional Risk, Frailty
- What is being tested?
- ERAS Protocol Compliance Assessment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2026to 9 Sep 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Aged 18 to 85 years
- Scheduled to undergo elective open heart surgery through median sternotomy under general anesthesia
- Able to provide written informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association of Compliance With the Enhanced Recovery After Surgery Protocol With Length of Hospital Stay, Nutritional Status, and Clinical Outcomes After Open Heart Surgery: A Prospective Cohort Study
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.
- Conditions
- Cardiac Surgery, Nutritional Risk, Frailty
- Being tested
- ERAS Protocol Compliance Assessment
- Keywords
- Enhanced Recovery After Surgery, ERAS Compliance, Prognostic Nutritional Index, NRS-2002, Clinical Frailty Scale, Open Heart Surgery
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERAS Protocol Compliance AssessmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: ERAS Protocol Compliance Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From the date of surgery to hospital discharge, up to 60 days
Secondary outcomes (3)
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.
Measured: From the preoperative assessment to 48 hours after surgery
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.
Measured: From surgery until hospital discharge, up to 30 days
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.
Measured: From the preoperative assessment to 48 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2026
- Study start1 Jun 2026
- Primary completion9 Sep 2026
- Study completion9 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bursa City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Emre Ulusoy, Bursa City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07783204
- Sponsor's protocol ID
- EU01
- Acronym
- ERAS-CARD
- Status last verified
- Sep 2026
- First submitted
- 20 Aug 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Compliance With the Enhanced Recovery After Surgery Protocol With Length of Hospital Stay, Nutritional Status, and Clinical Outcomes After Open Heart Surgery: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07783204
- Acronym / sponsor ID
- ERAS-CARD / EU01
- Conditions
- Cardiac Surgery, Nutritional Risk, Frailty
- Keywords
- Enhanced Recovery After Surgery, ERAS Compliance, Prognostic Nutritional Index, NRS-2002, Clinical Frailty Scale, Open Heart Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Bursa City HospitalOther government
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 9 Sep 2026 (actual)
- Study completion
- 9 Sep 2026 (actual)
- First posted
- 24 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High ERAS Compliance | – | Other: ERAS Protocol Compliance AssessmentParticipants 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. |
| Moderate ERAS Compliance | – | Other: ERAS Protocol Compliance AssessmentParticipants 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. |
| Low ERAS Compliance | – | Other: ERAS Protocol Compliance AssessmentParticipants 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Aged 18 to 85 years
- Scheduled to undergo elective open heart surgery through median sternotomy under general anesthesia
- Able to provide written informed consent
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ERAS Protocol Compliance AssessmentCompliance 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. | Other | High ERAS Compliance, Low ERAS Compliance, Moderate ERAS Compliance |
Primary outcome
Length of Hospital Stay
Time frame: From the date of surgery to hospital discharge, up to 60 days
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.
3 secondary outcomes
Change in Prognostic Nutritional Index
Time frame: From the preoperative assessment to 48 hours after surgery
Incidence of Postoperative Complications
Time frame: From surgery until hospital discharge, up to 30 days
Change in Nutritional Risk Screening 2002 Score
Time frame: From the preoperative assessment to 48 hours after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Surgery and Nutritional Risk, run by Bursa City Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of Hospital Stay (time frame: From the date of surgery to hospital discharge, up to 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.