Cardiac SurgeryNCT05914090
The Application of Enhanced Recovery After Surgery (ERAS) for Cardiovascular Surgery in Adult
A study testing ERAS in people with Cardiac Surgery and Enhanced Recovery After Surgery, run by Yan Fuxia at 2 sites in China.
Trial summary
Among adults, patients undergoing elective extracorporeal circulation for cardiac surgery are included in the ERAS strategy intervention plan, which mainly includes preoperative education, preoperative oral intake of multidimensional carbohydrate beverages, multimodal analgesia, blood protection strategies, correction… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cardiac Surgery, Enhanced Recovery After Surgery
- What is being tested?
- ERAS
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,600 participants
- Where
- 2 sitesChina
- Study dates
- 11 Oct 2023to 30 Dec 2024
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 to 80 years
- Patients awaiting elective cardiac surgery with cardiopulmonary bypass (CPB)
Who cannot join
- American Society of Anesthesiologists (ASA) class is above class V
- Patients with cardiac assist device or mechanical ventilation
- The ejection fraction of patients is less than 30%
- Patients with morbid obesity
- Patients with severe obstructive sleep apnea-hypopnea syndrome (OSAHS)
- Patients with severe pulmonary disease, including severe chronic obstructive pulmonary disease (COPD) or respiratory failure
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- Patients with severe liver or renal dysfunction, including severe acute or chronic renal dysfunction need renal replacement therapy, and acute or chronic liver failure need artificial liver therapy
- Patients with long-term opioid or sedative utilization
- Patients with a history of alcohol or cigarette abuse
- Patients with long-term hormone therapy
- An international normalized ratio > 2.0
- Patients with severe malnutrition
- Mental or legal disability
- Current enrollment in another clinical trial
- Patients' refusal or low adherence
Trial locations and contacts
2 sites in 1 country.
China2 sites
Fuwai hospital
China, Beijing Municipality, 100037
Fuxia Yan, Dr, 13641158173, yanfuxia@sina.com
Dou Dou, Dr., 18810601342, do.1995@163.com
Fuwai hospital
China, Beijing Municipality, 100037
Fuxia Yan/Principal investigator, 13641158173, yanfuxia@sina.com
About this study
Official title: The Application of Enhanced Recovery After Surgery (ERAS) for Cardiovascular Surgery in Adult: a Stepped Wedge Cluster Randomized Trial
Among adults, patients undergoing elective extracorporeal circulation for cardiac surgery are included in the ERAS strategy intervention plan, which mainly includes preoperative education, preoperative oral intake of multidimensional carbohydrate beverages, multimodal analgesia, blood protection strategies, correction of perioperative hypoalbuminemia, early removal of tracheal intubation, maintenance of blood sugar at reasonable levels, and targeted liquid therapy. The traditional plan group follows the current clinical diagnosis and treatment routine. By comparing the differences in the incidence of major postoperative outcomes (MACCE events, major pulmonary complications, and acute kidney injury) between the intervention group and the non intervention group, as well as comparing other adverse events (including but not limited to pneumonia, massive bleeding, postoperative arrhythmia, incision infection, postoperative nausea, vomiting, and delirium), all cause secondary intubation, and all cause secondary surgery between the two groups, and recording hospitalization time, ICU stay time The removal time of tracheal intubation and drainage tube, as well as the pain score during hospitalization and the total amount of opioid drug use (converted to equivalent dose morphine), hospitalization cost, postoperative recovery quality QoR15 scale score, and patient satisfaction score, were recorded to explore whether the ERAS regimen can reduce the incidence of major postoperative adverse events, improve patient prognosis, and accelerate postoperative recovery compared to traditional regimens.
- Conditions
- Cardiac Surgery, Enhanced Recovery After Surgery
- Being tested
- ERAS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERASProcedure or surgery
Among adults, patients undergoing elective extracorporeal circulation for cardiac surgery are included in the ERAS strategy intervention plan, which mainly includes preoperative education, preoperative oral intake of multidimensional carbohydrate beverages, multimodal analgesia, blood protection strategies, correction of perioperative hypoalbuminemia, early removal of tracheal intubation, maintenance of blood sugar at reasonable levels, and targeted liquid therapy.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Not described Receives: Procedure: ERAS |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite outcomes
The composite outcomes include the major adverse cardiac and cerebrovascular events (MACCE), major postoperative pulmonary complication (PPCs), and acute kidney injury (AKI).
Measured: during hospitalization, an average of 1 week, assessed up to 30 days
Secondary outcomes (11)
the quality of recovery score (QoR)-15 after surgery
Measured: At 24 hour after surgery
length of hospital stay
From the date of admission until the date of discharging
Measured: From the date of admission until the date of discharging, assessed up to 30 days
the duration of intensive care unit (ICU) stay
Time from ICU admission to ICU discharge
Measured: Time from ICU admission to ICU discharge, assessed up to 30 days
time to extubation
The time from the end of operation to the removal of tracheal intubation
Measured: The time from the end of operation to the removal of tracheal intubation, assessed up to 30 days
time to drainage removal
The time from the end of operation to the removal of drainage tube
Measured: The time from the end of operation to the removal of drainage tube, assessed up to 30 days
the rate of other complications
The rate of other complications include delium, pneumonia, pneumothorax, hematorrhea and so on
Measured: during hospitalization, an average of 1 week, assessed up to 30 days
the rate of reintubation for any cause
The rate of reintubation for any cause
Measured: during hospitalization, an average of 1 week, assessed up to 30 days
cumulative opioid dosage
Total perioperative consumption of opioid analgesics
Measured: during hospitalization, an average of 1 week, assessed up to 30 days
overall medical costs
Total cost of patients during hospitalization
Measured: during hospitalization, an average of 1 week, assessed up to 30 days
satisfaction score
A satisfaction rating using a 0-10 number scale (0=unsatisfactory, 10=satisfactory)
Measured: the day before discharge, assessed up to 30 days
the outcomes of long-term prognosis by telephone follow-up
the outcomes of prognosis
Measured: within 30 days, 3 months, and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start11 Oct 2023 (estimated)
- Primary completion1 Jun 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 3,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yan Fuxia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yan Fuxia, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05914090
- Sponsor's protocol ID
- 2023--1968
- Status last verified
- Oct 2023
- First submitted
- 15 May 2023
- Last updated
- 13 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Application of Enhanced Recovery After Surgery (ERAS) for Cardiovascular Surgery in Adult: a Stepped Wedge Cluster Randomized Trial
- ClinicalTrials.gov ID
- NCT05914090
- Acronym / sponsor ID
- 2023--1968
- Conditions
- Cardiac Surgery, Enhanced Recovery After Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3,600 participants (estimated)
- Lead sponsor
- Yan FuxiaUniversity, hospital or other
- Study start
- 11 Oct 2023 (estimated)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 22 Jun 2023 (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.
Among adults, patients undergoing elective extracorporeal circulation for cardiac surgery are included in the ERAS strategy intervention plan, which mainly includes preoperative education, preoperative oral intake of multidimensional carbohydrate beverages, multimodal analgesia, blood protection strategies, correction of perioperative hypoalbuminemia, early removal of tracheal intubation, maintenance of blood sugar at reasonable levels, and targeted liquid therapy. The traditional plan group follows the current clinical diagnosis and treatment routine. By comparing the differences in the incidence of major postoperative outcomes (MACCE events, major pulmonary complications, and acute kidney injury) between the intervention group and the non intervention group, as well as comparing other adverse events (including but not limited to pneumonia, massive bleeding, postoperative arrhythmia, incision infection, postoperative nausea, vomiting, and delirium), all cause secondary intubation, and all cause secondary surgery between the two groups, and recording hospitalization time, ICU stay time The removal time of tracheal intubation and drainage tube, as well as the pain score during hospitalization and the total amount of opioid drug use (converted to equivalent dose morphine), hospitalization cost, postoperative recovery quality QoR15 scale score, and patient satisfaction score, were recorded to explore whether the ERAS regimen can reduce the incidence of major postoperative adverse events, improve patient prognosis, and accelerate postoperative recovery compared to traditional regimens.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Procedure: ERAS |
| Control group | No intervention | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients aged 18 to 80 years
- Patients awaiting elective cardiac surgery with cardiopulmonary bypass (CPB)
Key exclusion criteria (15 listed)
- American Society of Anesthesiologists (ASA) class is above class V
- Patients with cardiac assist device or mechanical ventilation
- The ejection fraction of patients is less than 30%
- Patients with morbid obesity
- Patients with severe obstructive sleep apnea-hypopnea syndrome (OSAHS)
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 |
|---|---|---|
| ERASAmong adults, patients undergoing elective extracorporeal circulation for cardiac surgery are included in the ERAS strategy intervention plan, which mainly includes preoperative education, preoperative oral intake of multidimensional carbohydrate beverages, multimodal analgesia, blood protection strategies, correction of perioperative hypoalbuminemia, early removal of tracheal intubation, maintenance of blood sugar at reasonable levels, and targeted liquid therapy. | Procedure or surgery | Intervention group |
Primary outcome
Composite outcomes
Time frame: during hospitalization, an average of 1 week, assessed up to 30 days
The composite outcomes include the major adverse cardiac and cerebrovascular events (MACCE), major postoperative pulmonary complication (PPCs), and acute kidney injury (AKI).
11 secondary outcomes
the quality of recovery score (QoR)-15 after surgery
Time frame: At 24 hour after surgery
length of hospital stay
Time frame: From the date of admission until the date of discharging, assessed up to 30 days
the duration of intensive care unit (ICU) stay
Time frame: Time from ICU admission to ICU discharge, assessed up to 30 days
time to extubation
Time frame: The time from the end of operation to the removal of tracheal intubation, assessed up to 30 days
time to drainage removal
Time frame: The time from the end of operation to the removal of drainage tube, assessed up to 30 days
the rate of other complications
Time frame: during hospitalization, an average of 1 week, assessed up to 30 days
the rate of reintubation for any cause
Time frame: during hospitalization, an average of 1 week, assessed up to 30 days
cumulative opioid dosage
Time frame: during hospitalization, an average of 1 week, assessed up to 30 days
overall medical costs
Time frame: during hospitalization, an average of 1 week, assessed up to 30 days
satisfaction score
Time frame: the day before discharge, assessed up to 30 days
the outcomes of long-term prognosis by telephone follow-up
Time frame: within 30 days, 3 months, and 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2023.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ERAS in people with Cardiac Surgery and Enhanced Recovery After Surgery, run by Yan Fuxia at 2 sites in China.
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 2 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 13 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yan/Principle investigator (13641158173, yanfuxia@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite outcomes (time frame: during hospitalization, an average of 1 week, assessed up to 30 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 13 Oct 2023.