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

NCT ID: NCT05914090

Last Updated: 2023-10-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 3600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-11
• Study Completion Date: 2024-12-30

Brief 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.

Conditions

Cardiac Surgery; Enhanced Recovery After Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Intervention group

Group Type: EXPERIMENTAL

ERAS

Intervention Type: PROCEDURE

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.

Control group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yan Fuxia

OTHER

Sponsor Role: lead

Responsible Party

Yan Fuxia

principal investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Fuwai hospital

China, Beijing Municipality, China

Fuwai hospital

China, Beijing Municipality, China

Countries

China

Central Contacts

Yan/Principle investigator

Role: CONTACT

yanfuxia@sina.com

13641158173

Facility Contacts

Fuxia Yan, Dr

Role: primary

yanfuxia@sina.com

13641158173

Dou Dou, Dr.

Role: backup

do.1995@163.com

18810601342

Fuxia Yan/Principal investigator

Role: primary

yanfuxia@sina.com

13641158173

Other Identifiers

2023--1968

Identifier Type: -

Identifier Source: org_study_id