Enhanced Recovery After SurgeryERACS2NCT06257745
Audit of the Revised PACU Centric ERACS Program
An observational study of Enhanced Recovery After Surgery and Cardiac Surgical Procedures, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
A previous audit (S63843) found an association between improved compliance with these interventions and postoperative outcomes (hospital length of stay (LOS) and presence of ≥1 postoperative complication). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Enhanced Recovery After Surgery, Cardiac Surgical Procedures
- What is being tested?
- Compliance with ERACS guideline as described in the current ERACS guidelines from Engelman et al. 2019
- How many people
- 487 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jan 2024to 31 Jan 2025
- How long will I take part?
- 1 Month
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: any patient undergoing cardiac surgery in our hospital and requiring admittance to a high-depency unit for overnight stay.
Who may be able to join
- Included in our post anesthesia care unit centric ERACS program during 2024
Who cannot join
- Patients transferred to the PACU but awaiting planned admission to the intensive care unit following cardiac surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Revised Enhanced Recovery After Cardiac Surgery Protocol. A Prospective Audit.
A previous audit (S63843) found an association between improved compliance with these interventions and postoperative outcomes (hospital length of stay (LOS) and presence of ≥1 postoperative complication). The investigators found that every 10% increase in compliance was associated with an increased risk (HR=1.25, p=0.0008) for early discharge. In addition, improved compliance was also associated with a reduction (OR=0.60, p=0.0003) of postoperative complications. Based on these findings, improving compliance with current guidelines remains a hurdle that clinicians should overcome. The investigators previous retrospective study was unable to identify the reason for non-compliance and the relation to postoperative outcomes. Therefore, a prospective audit is warranted to assess reach, fidelity, and dose of the different interventions.
Read the detailed description
Trial Design:
Prospective audit in patients undergoing cardiac surgery and planned for overnight stay within our post-anesthesia care unit (PACU) enhanced recovery after cardiac surgery (ERACS) program. The medical records of all patients will be evaluated for the implementation of various interventions of our ERACS program (primary objective). For the secondary objective the investigators will assess the occurrence of postoperative complications and hospital LOS.
For benchmarking (third objective), the investigators will compare the findings with the results of a previous audit (S63843).(4) Data in this retrospective audit was collected from the electronic patient registry (KWS = Klinisch Werk Station). This included all interventions described in the ERACS guidelines. In addition, postoperative complications that occurred up to 7 days were also collected.
Data management:
Data will be obtained, according to the strategy used in the previous audit (S63843), by a research collaborator and an anesthesiologist using the medical records of the included patients. Appropriate data will also be collected from the preoperative anesthesia evaluation sheets (digitally stored in the hospital information system, KWS Nexus health) and from all intra- and postoperative anesthesia records up to 30 days after the index surgery.
Statistics:
The investigators aim for a convenience sample of 1-year recruitment, from January 1st 2024 until December 31st 2024 and expect to include approximately 350 cardiac surgical patients in this ERACS audit.
Patient characteristics will be tabulated as absolute numbers, percentages, mean and standard deviation, Objective 1 95% confidence intervals will be reported for the mean (or median) percentage compliances well as for each of the interventions separately, the proportion of patients who adhere to the intervention.
Objective 2 Logistic regressions will be used to verify the relation between the percentage adherence and the presence of a complication (for each complication separately and for the composite endpoint). Odds ratios and 95% confidence intervals will be reported. These analyses will also be performed for the adherence at each intervention separately (fidelity and dose). Spearman correlations and MWU tests will be used to explore relations between adherence (percentage and each intervention separately) and length of hospital stay. Given the possible presence of in-hospital mortality, a LOS value higher than the maximal observed value of the discharged patients will be given to patients who die in the hospital when applying these rank-based methods. Further, Cox regressions will be used to model the cause-specific hazard in presence of in-hospital mortality and hazard ratios (with 95%CI) will be given. A multivariable logistic regression will be used to verify if the relation between protocol adherence and postoperative complications is not confounded by patient (e.g. EuroSCORE II) and procedural (e.g. type of surgery being valvular, bypass or minimally invasive) characteristics. To verify the independent impact of protocol adherence on length of stay, a multivariable Cox regression will be used.
Objective 3 For benchmarking purposes, the percentage adherence will be compared between current sample and the data of the retrospective study using a linear normal model, correcting for potential differences in patient-mix (patient and procedural characteristics) between both periods. Note however that differences are expected to be minimal, since the same inclusion criteria were used, and the accrual period covered a full year. To compare the adherence to each intervention separately and to compare the complication rate(s) a logistic regression will be used.
A p-value of less than 0.05 will be considered statistically significant. Given the large number of planned statistical tests, a single significant p-value will be interpreted with caution.
- Being tested
- Compliance with ERACS guideline as described in the current ERACS guidelines from Engelman et al. 2019
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compliance with ERACS guideline as described in the current ERACS guidelines from Engelman et al. 2019Other
Compliance with the interventions as proposed in the ERACS guidelines and described in our previous publication (https://doi.org/10.1016/j.jtcvs.2022.07.010
| Study group | Role | What they receive |
|---|---|---|
| ERACS group | Any patient admitted to our post-anesthesia care unit following cardiac surgery and planned for overnight stay. Receives: Other: Compliance with ERACS guideline as described in the current ERACS guidelines from Engelman et al. 2019 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall percentage of compliance with the 24 interventions of the ERACS guidelines
Performed interventions as described in the ERACS guidelines and adapted to local standards
Measured: From 6 week prior to surgery up to 1 month after surgery
Secondary outcomes (5)
Hospital length of stay following the index surgery
Number of nights in the hospital
Measured: From date of surgery until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 30days.
Occurrence of each postoperative complication during the first 7 days
Complications as described in our previous publication (https://doi.org/10.1016/j.jtcvs.2022.07.010)
Measured: From date of surgery up to 7 postoperative days
Composite endpoint of 1 or more postoperative complications
Complications as described in our previous publication (https://doi.org/10.1016/j.jtcvs.2022.07.010)
Measured: From date of surgery up to 7 postoperative days
Percentage of patients in whom each ERACS intervention was performed as intended (referred to as fidelity)
Interventions as described in the ERACS guidelines
Measured: From 6 week prior to surgery up to 1 month after surgery
Percentage of patients in whom each the frequency of ERACS intervention was performed as planned (referred to as dose)
Number of interventions as described in the ERACS guidelines
Measured: From 6 week prior to surgery up to 1 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2024
- Study start1 Jan 2024
- Primary completion31 Jan 2025
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Enhanced Recovery After SurgeryStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- 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
- 487 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Danny Feike Hoogma, MD, PhD, Principal investigator, Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06257745
- Sponsor's protocol ID
- s68333
- Acronym
- ERACS2
- Status last verified
- Jan 2024
- First submitted
- 25 Jan 2024
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD is available upon request from the primary investigator.
Publications
Engelman DT, Ben Ali W, Williams JB, Perrault LP, Reddy VS, Arora RC, Roselli EE, Khoynezhad A, Gerdisch M, Levy JH, Lobdell K, Fletcher N, Kirsch M, Nelson G, Engelman RM, Gregory AJ, Boyle EM. Guidelines for Perioperative Care in Cardiac Surgery: Enhanced Recovery After Surgery Society Recommendations. JAMA Surg. 2019 Aug 1;154(8):755-766. doi: 10.1001/jamasurg.2019.1153.
PubMed 31054241Hoogma DF, Croonen R, Al Tmimi L, Tournoy J, Verbrugghe P, Fieuws S, Rex S. Association between improved compliance with enhanced recovery after cardiac surgery guidelines and postoperative outcomes: A retrospective study. J Thorac Cardiovasc Surg. 2024 Apr;167(4):1363-1371.e2. doi: 10.1016/j.jtcvs.2022.07.010. Epub 2022 Jul 19.
PubMed 35989120Fleming IO, Garratt C, Guha R, Desai J, Chaubey S, Wang Y, Leonard S, Kunst G. Aggregation of Marginal Gains in Cardiac Surgery: Feasibility of a Perioperative Care Bundle for Enhanced Recovery in Cardiac Surgical Patients. J Cardiothorac Vasc Anesth. 2016 Jun;30(3):665-70. doi: 10.1053/j.jvca.2016.01.017. Epub 2016 Jan 16.
PubMed 27321791Van Grootven B, Jeuris A, Jonckers M, Devriendt E, Dierckx de Casterle B, Dubois C, Fagard K, Herregods MC, Hornikx M, Meuris B, Rex S, Tournoy J, Milisen K, Flamaing J, Deschodt M. How to implement geriatric co-management in your hospital? Insights from the G-COACH feasibility study. BMC Geriatr. 2022 May 2;22(1):386. doi: 10.1186/s12877-022-03051-1.
PubMed 35501840
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Revised Enhanced Recovery After Cardiac Surgery Protocol. A Prospective Audit.
- ClinicalTrials.gov ID
- NCT06257745
- Acronym / sponsor ID
- ERACS2 / s68333
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 487 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 14 Feb 2024 (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.
A previous audit (S63843) found an association between improved compliance with these interventions and postoperative outcomes (hospital length of stay (LOS) and presence of ≥1 postoperative complication). The investigators found that every 10% increase in compliance was associated with an increased risk (HR=1.25, p=0.0008) for early discharge. In addition, improved compliance was also associated with a reduction (OR=0.60, p=0.0003) of postoperative complications. Based on these findings, improving compliance with current guidelines remains a hurdle that clinicians should overcome. The investigators previous retrospective study was unable to identify the reason for non-compliance and the relation to postoperative outcomes. Therefore, a prospective audit is warranted to assess reach, fidelity, and dose of the different interventions.
Detailed description
Trial Design:
Prospective audit in patients undergoing cardiac surgery and planned for overnight stay within our post-anesthesia care unit (PACU) enhanced recovery after cardiac surgery (ERACS) program. The medical records of all patients will be evaluated for the implementation of various interventions of our ERACS program (primary objective). For the secondary objective the investigators will assess the occurrence of postoperative complications and hospital LOS.
For benchmarking (third objective), the investigators will compare the findings with the results of a previous audit (S63843).(4) Data in this retrospective audit was collected from the electronic patient registry (KWS = Klinisch Werk Station). This included all interventions described in the ERACS guidelines. In addition, postoperative complications that occurred up to 7 days were also collected.
Data management:
Data will be obtained, according to the strategy used in the previous audit (S63843), by a research collaborator and an anesthesiologist using the medical records of the included patients. Appropriate data will also be collected from the preoperative anesthesia evaluation sheets (digitally stored in the hospital information system, KWS Nexus health) and from all intra- and postoperative anesthesia records up to 30 days after the index surgery.
Statistics:
The investigators aim for a convenience sample of 1-year recruitment, from January 1st 2024 until December 31st 2024 and expect to include approximately 350 cardiac surgical patients in this ERACS audit.
Patient characteristics will be tabulated as absolute numbers, percentages, mean and standard deviation, Objective 1 95% confidence intervals will be reported for the mean (or median) percentage compliances well as for each of the interventions separately, the proportion of patients who adhere to the intervention.
Objective 2 Logistic regressions will be used to verify the relation between the percentage adherence and the presence of a complication (for each complication separately and for the composite endpoint). Odds ratios and 95% confidence intervals will be reported. These analyses will also be performed for the adherence at each intervention separately (fidelity and dose). Spearman correlations and MWU tests will be used to explore relations between adherence (percentage and each intervention separately) and length of hospital stay. Given the possible presence of in-hospital mortality, a LOS value higher than the maximal observed value of the discharged patients will be given to patients who die in the hospital when applying these rank-based methods. Further, Cox regressions will be used to model the cause-specific hazard in presence of in-hospital mortality and hazard ratios (with 95%CI) will be given. A multivariable logistic regression will be used to verify if the relation between protocol adherence and postoperative complications is not confounded by patient (e.g. EuroSCORE II) and procedural (e.g. type of surgery being valvular, bypass or minimally invasive) characteristics. To verify the independent impact of protocol adherence on length of stay, a multivariable Cox regression will be used.
Objective 3 For benchmarking purposes, the percentage adherence will be compared between current sample and the data of the retrospective study using a linear normal model, correcting for potential differences in patient-mix (patient and procedural characteristics) between both periods. Note however that differences are expected to be minimal, since the same inclusion criteria were used, and the accrual period covered a full year. To compare the adherence to each intervention separately and to compare the complication rate(s) a logistic regression will be used.
A p-value of less than 0.05 will be considered statistically significant. Given the large number of planned statistical tests, a single significant p-value will be interpreted with caution.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ERACS group | – | Other: Compliance with ERACS guideline as described in the current ERACS guidelines from Engelman et al. 2019Any patient admitted to our post-anesthesia care unit following cardiac surgery and planned for overnight stay. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- any patient undergoing cardiac surgery in our hospital and requiring admittance to a high-depency unit for overnight stay.
Key inclusion criteria (1 listed)
- Included in our post anesthesia care unit centric ERACS program during 2024
Key exclusion criteria (1 listed)
- Patients transferred to the PACU but awaiting planned admission to the intensive care unit following cardiac surgery
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 |
|---|---|---|
| Compliance with ERACS guideline as described in the current ERACS guidelines from Engelman et al. 2019Compliance with the interventions as proposed in the ERACS guidelines and described in our previous publication (https://doi.org/10.1016/j.jtcvs.2022.07.010 | Other | ERACS group |
Primary outcome
Overall percentage of compliance with the 24 interventions of the ERACS guidelines
Time frame: From 6 week prior to surgery up to 1 month after surgery
Performed interventions as described in the ERACS guidelines and adapted to local standards
5 secondary outcomes
Hospital length of stay following the index surgery
Time frame: From date of surgery until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 30days.
Occurrence of each postoperative complication during the first 7 days
Time frame: From date of surgery up to 7 postoperative days
Composite endpoint of 1 or more postoperative complications
Time frame: From date of surgery up to 7 postoperative days
Percentage of patients in whom each ERACS intervention was performed as intended (referred to as fidelity)
Time frame: From 6 week prior to surgery up to 1 month after surgery
Percentage of patients in whom each the frequency of ERACS intervention was performed as planned (referred to as dose)
Time frame: From 6 week prior to surgery up to 1 month 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 May 2026.
- Background: PubMed 31054241Engelman DT, Ben Ali W, Williams JB, Perrault LP, Reddy VS, Arora RC, Roselli EE, Khoynezhad A, Gerdisch M, Levy JH, Lobdell K, Fletcher N, Kirsch M, Nelson G, Engelman RM, Gregory AJ, Boyle EM. Guidelines for Perioperative Care in Cardiac Surgery: Enhanced Recovery After Surgery Society Recommendations. JAMA Surg. 2019 Aug 1;154(8):755-766. doi: 10.1001/jamasurg.2019.1153.
- Background: PubMed 35989120Hoogma DF, Croonen R, Al Tmimi L, Tournoy J, Verbrugghe P, Fieuws S, Rex S. Association between improved compliance with enhanced recovery after cardiac surgery guidelines and postoperative outcomes: A retrospective study. J Thorac Cardiovasc Surg. 2024 Apr;167(4):1363-1371.e2. doi: 10.1016/j.jtcvs.2022.07.010. Epub 2022 Jul 19.
- Background: PubMed 27321791Fleming IO, Garratt C, Guha R, Desai J, Chaubey S, Wang Y, Leonard S, Kunst G. Aggregation of Marginal Gains in Cardiac Surgery: Feasibility of a Perioperative Care Bundle for Enhanced Recovery in Cardiac Surgical Patients. J Cardiothorac Vasc Anesth. 2016 Jun;30(3):665-70. doi: 10.1053/j.jvca.2016.01.017. Epub 2016 Jan 16.
- Background: PubMed 35501840Van Grootven B, Jeuris A, Jonckers M, Devriendt E, Dierckx de Casterle B, Dubois C, Fagard K, Herregods MC, Hornikx M, Meuris B, Rex S, Tournoy J, Milisen K, Flamaing J, Deschodt M. How to implement geriatric co-management in your hospital? Insights from the G-COACH feasibility study. BMC Geriatr. 2022 May 2;22(1):386. doi: 10.1186/s12877-022-03051-1.
- Individual participant dataSharing planned: Yes. IPD is available upon request from the primary investigator.
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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.
Danny Feike Hoogma, MD, PhD principal investigator
Anesthesiology
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 Enhanced Recovery After Surgery and Cardiac Surgical Procedures, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 1 inclusion and 1 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 May 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 Belgium. 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?
Overall percentage of compliance with the 24 interventions of the ERACS guidelines (time frame: From 6 week prior to surgery up to 1 month after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06257745, which also lists 4 linked publications.
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 May 2026.