Complex Congenital Heart DiseaseNCT05914103
The Application of Enhanced Recovery After Surgery (ERAS) for Cardiovascular Surgery in the Correction of Complex Congenital Heart Disease
A study testing ERAS in people with Complex Congenital Heart Disease and Enhanced Recovery After Surgery, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 2 sites in China.
Trial summary
This study is a multicenter, stepwise design, cluster randomized controlled trial. Random sequence is generated by computer, and each center enters the intervention expectation (Phase I) in random order to implement ERAS strategy. Read more about this study
- Who is it for?
- Ages 28 days to 6 years
- Conditions the study is for
- Complex Congenital Heart Disease, Enhanced Recovery After Surgery
- What is being tested?
- ERAS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,030 participants
- Where
- 2 sitesChina
- Study dates
- 1 Jul 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 28 days to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients aged 28 days to 6 years
- Patients awaiting elective cardiac surgery with cardiopulmonary bypass (CPB).
Who cannot join
- The risk adjustment for congenital heart surgery (RACHS) is above class 5
- Patients with cardiac assist device, mechanical ventilation or the history of asphyxia
- Patients with pulmonary disease, including respiratory tract infections and asthma
- 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
- Fetal malformation includes polysplenia syndrome, Asplenia Syndrome, Down syndrome, DiGeoge syndrome, Marfan syndrome, trachea-bronchus stricture, diabetes, nervous functioning disorders, genital system malformations, imperforate anus, and Williams syndrome
- Current enrollment in another clinical trial
- Guardian's refusal or low adherence
Trial locations and contacts
2 sites in 1 country.
China2 sites
Fuwai hospital
Beijing, Beijing Municipality, 100037
Fuxia Yan, Dr, 13641158173, yanfuxia@sina.com
Dou Dou, Dr, 18810601342, do.1995@163.com
Fuwai hospital
China, Beijing Municipality, 100037
About this study
Official title: The Application of Enhanced Recovery After Surgery (ERAS) for Cardiovascular Surgery in the Correction of Complex Congenital Heart Disease: a Stepped Wedge Cluster Randomized Trial
This study is a multicenter, stepwise design, cluster randomized controlled trial. Random sequence is generated by computer, and each center enters the intervention expectation (Phase I) in random order to implement ERAS strategy. If it does not enter the intervention expectation (Phase C) center, clinical diagnosis and treatment will be completed according to the traditional scheme.
Among children, patients aged 28 to 6 who underwent cardiac surgery were included in the ERAS strategy intervention plan, which mainly includes preoperative education, preoperative comfort for the patient, preoperative oral sugary beverage, continuous infusion of dexmedetomidine, multimodal analgesia, blood protection strategies, prevention of postoperative nausea and vomiting, intraoperative insulation, early tracheal extubation and intubation, 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 (MACE 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, the pain score during hospitalization, the total amount of opioid drug use (converted to the same dose of morphine), hospitalization expenses, and family satisfaction scores 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.
- 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
The primary endpoint is the rate of composite outcomes. The composite outcomes include the major adverse cardiac events (MACE), major postoperative pulmonary complication (PPCs), and acute kidney injury (AKI)
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: Procedure: ERAS |
| Control | 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 events (MACE), 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 (10)
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 cumulative incidence of death from any cause within 30 days and 1 year
the cumulative incidence of death from any cause within 30 days and 1 year
Measured: within 30 days 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 start1 Jul 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Complex Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Chinese Academy of Medical Sciences, Fuwai HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 3,030 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Fuwai Yunnan Cardiovascular Hospital, Beijing Anzhen Hospital, The Second People's Hospital of GuangDong Province, Shanghai Children's Medical Center
- Responsible party
- Principal investigator, Yan Fuxia, Chinese Academy of Medical Sciences, Fuwai Hospital
- Investigators
- Yan, Principal investigator, Fuxia hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05914103
- Sponsor's protocol ID
- 2023-1969
- Status last verified
- Jun 2023
- First submitted
- 17 May 2023
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dou D, Jia Y, Yuan S, Wang Y, Li Y, Wang H, Ding J, Wu X, Bie D, Liu Q, An R, Yan H, Yan F. The protocol of Enhanced Recovery After Cardiac Surgery (ERACS) in congenital heart disease: a stepped wedge cluster randomized trial. BMC Pediatr. 2024 Jan 5;24(1):22. doi: 10.1186/s12887-023-04422-2.
PubMed 38183047
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 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 the Correction of Complex Congenital Heart Disease: a Stepped Wedge Cluster Randomized Trial
- ClinicalTrials.gov ID
- NCT05914103
- Acronym / sponsor ID
- 2023-1969
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3,030 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai HospitalUniversity, hospital or other
- Collaborators
- Fuwai Yunnan Cardiovascular Hospital, Beijing Anzhen Hospital, The Second People's Hospital of GuangDong Province, Shanghai Children's Medical Center
- Study start
- 1 Jul 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.
This study is a multicenter, stepwise design, cluster randomized controlled trial. Random sequence is generated by computer, and each center enters the intervention expectation (Phase I) in random order to implement ERAS strategy. If it does not enter the intervention expectation (Phase C) center, clinical diagnosis and treatment will be completed according to the traditional scheme.
Among children, patients aged 28 to 6 who underwent cardiac surgery were included in the ERAS strategy intervention plan, which mainly includes preoperative education, preoperative comfort for the patient, preoperative oral sugary beverage, continuous infusion of dexmedetomidine, multimodal analgesia, blood protection strategies, prevention of postoperative nausea and vomiting, intraoperative insulation, early tracheal extubation and intubation, 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 (MACE 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, the pain score during hospitalization, the total amount of opioid drug use (converted to the same dose of morphine), hospitalization expenses, and family satisfaction scores 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 | Experimental | Procedure: ERAS |
| Control | No intervention | – |
Who may qualify
- Ages
- 28 days to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Patients aged 28 days to 6 years
- Patients awaiting elective cardiac surgery with cardiopulmonary bypass (CPB).
Key exclusion criteria (7 listed)
- The risk adjustment for congenital heart surgery (RACHS) is above class 5
- Patients with cardiac assist device, mechanical ventilation or the history of asphyxia
- Patients with pulmonary disease, including respiratory tract infections and asthma
- 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
- Fetal malformation includes polysplenia syndrome, Asplenia Syndrome, Down syndrome, DiGeoge syndrome, Marfan syndrome, trachea-bronchus stricture, diabetes, nervous functioning disorders, genital system malformations, imperforate anus, and Williams syndrome
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 |
|---|---|---|
| ERASThe primary endpoint is the rate of composite outcomes. The composite outcomes include the major adverse cardiac events (MACE), major postoperative pulmonary complication (PPCs), and acute kidney injury (AKI) | Procedure or surgery | Intervention |
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 events (MACE), major postoperative pulmonary complication (PPCs), and acute kidney injury (AKI)
10 secondary outcomes
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 cumulative incidence of death from any cause within 30 days and 1 year
Time frame: within 30 days 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 22 Jun 2023.
- Derived from this study: PubMed 38183047Dou D, Jia Y, Yuan S, Wang Y, Li Y, Wang H, Ding J, Wu X, Bie D, Liu Q, An R, Yan H, Yan F. The protocol of Enhanced Recovery After Cardiac Surgery (ERACS) in congenital heart disease: a stepped wedge cluster randomized trial. BMC Pediatr. 2024 Jan 5;24(1):22. doi: 10.1186/s12887-023-04422-2.
- 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.
Yan principal investigator
Fuxia hospital
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 Complex Congenital Heart Disease and Enhanced Recovery After Surgery, run by Chinese Academy of Medical Sciences, Fuwai Hospital 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 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: status not confirmed, as of the sponsor's last update on 22 Jun 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 Fuxia Yan (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?
On the ClinicalTrials.gov record for NCT05914103, which also lists 1 linked publication.
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 22 Jun 2023.