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

NCT05914090 | Unknown DMC

• 1 other identifier: 2023--1968
• Study Type: interventional
• Target: 3,600
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• the quality of recovery score (QoR)-15 after surgery

  At 24 hour after surgery

• length of hospital stay

  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, assessed up to 30 days

• time to extubation

  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, assessed up to 30 days

Study Arms (2)

Intervention group

EXPERIMENTAL

Procedure: ERAS

Control group

NO INTERVENTION

Interventions

ERAS 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.

Intervention group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yan Fuxia: lead

Study Sites (2)

Fuwai hospital

China, Beijing Municipality, 100037, China

Location

Fuwai hospital

China, Beijing Municipality, 100037, China

Location

Central Study Contacts

Yan/Principle investigator

CONTACT

13641158173; yanfuxia@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: May 15, 2023
• First Posted: June 22, 2023
• Study Start: October 11, 2023
• Primary Completion: June 1, 2024
• Study Completion: December 30, 2024
• Last Updated: October 13, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)