The Application of Enhanced Recovery After Surgery (ERAS) for Cardiovascular Surgery in Adult

Cardiac Surgery Clinical Trial

Official title:

The Application of Enhanced Recovery After Surgery (ERAS) for Cardiovascular Surgery in Adult: a Stepped Wedge Cluster Randomized Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05914090
• Other study ID #: 2023--1968
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 11, 2023
• Est. completion date: December 30, 2024

Study information

• Verified date: October 2023
• Source: Chinese Academy of Medical Sciences, Fuwai Hospital
• Contact: Yan/Principle investigator
• Phone: 13641158173
• Email: yanfuxia[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 3600
• Est. completion date: December 30, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients aged 18 to 80 years
• Patients awaiting elective cardiac surgery with cardiopulmonary bypass (CPB)

Exclusion Criteria:

• 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
• 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

Related Conditions & MeSH terms

• Cardiac Surgery
• Enhanced Recovery After Surgery

Intervention

Procedure:
• ERAS
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.

Locations

Country	Name	City	State
China	Fuwai hospital	China	Beijing
China	Fuwai hospital	China	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Yan Fuxia

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite outcomes	The composite outcomes include the major adverse cardiac and cerebrovascular events (MACCE), major postoperative pulmonary complication (PPCs), and acute kidney injury (AKI).	during hospitalization, an average of 1 week, assessed up to 30 days
Secondary	the quality of recovery score (QoR)-15 after surgery		At 24 hour after surgery
Secondary	length of hospital stay	From the date of admission until the date of discharging	From the date of admission until the date of discharging, assessed up to 30 days
Secondary	the duration of intensive care unit (ICU) stay	Time from ICU admission to ICU discharge	Time from ICU admission to ICU discharge, assessed up to 30 days
Secondary	time to extubation	The time from the end of operation to the removal of tracheal intubation	The time from the end of operation to the removal of tracheal intubation, assessed up to 30 days
Secondary	time to drainage removal	The time from the end of operation to the removal of drainage tube	The time from the end of operation to the removal of drainage tube, assessed up to 30 days
Secondary	the rate of other complications	The rate of other complications include delium, pneumonia, pneumothorax, hematorrhea and so on	during hospitalization, an average of 1 week, assessed up to 30 days
Secondary	the rate of reintubation for any cause	The rate of reintubation for any cause	during hospitalization, an average of 1 week, assessed up to 30 days
Secondary	cumulative opioid dosage	Total perioperative consumption of opioid analgesics	during hospitalization, an average of 1 week, assessed up to 30 days
Secondary	overall medical costs	Total cost of patients during hospitalization	during hospitalization, an average of 1 week, assessed up to 30 days
Secondary	satisfaction score	A satisfaction rating using a 0-10 number scale (0=unsatisfactory, 10=satisfactory)	the day before discharge, assessed up to 30 days
Secondary	the outcomes of long-term prognosis by telephone follow-up	the outcomes of prognosis	within 30 days, 3 months, and 1 year