The Impact of ERAS Program in Cardiac Surgery on Patient Prognosis

ERAS Clinical Trial

Official title:

The Impact of ERAS Program in Cardiac Surgery on Patient Prognosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04642274
• Other study ID #: ERAS in CS
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: November 2021
• Source: Shanghai Zhongshan Hospital
• Contact: Guo Kefang, MD
• Phone: +86-13817706936
• Email: drguokefang[@]foxmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the study is to develop, verify and optimize the ERAS protocol for cardiac surgery.

Description:

The aim of the study is to develop, verify and optimize the ERAS protocol for cardiac surgery, thereby improving the overall prognosis of cardiac surgery patients, reducing the incidence of complications, and shortening the length of hospital stay.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 31, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• ASA II/III

• BMI 16.5-31 kg/?

• Elective cardiac surgery under CPB

• Volunteer to participate and sign informed consent

Exclusion Criteria:

• Redo cardiac surgery

• Patients who do not cooperate or cannot communicate

• Abusers of alcohol, drugs or narcotics

• Pregnant or Breastfeeding

Related Conditions & MeSH terms

• ERAS

Intervention

Other:
• Nutrition
Correct the patient's low nutritional status before surgery.
• Control Blood Glucose
Control the patient's blood glucose before surgery, fasting blood glucose level = 8mmol/L or HbA1c = 7%.

Drug:
• Fasting
Take 10% glucose water 6ml/kg 2 to 4 hours before operation (except for diabetes).

Behavioral:
• Smoking and Alcohol
Quit smoking and alcohol before surgery

Other:
• Control Anemia
Correct anemia before surgery
• Blood Transfusion
Use strict blood transfusion indications and blood protection strategy during surgery.
• GDFT
Use goal-directed fluid therapy during surgery.
• Remove the tracheal tube
Remove the tracheal tube as soon as possible after surgery.

Behavioral:
• Eating and Drinking
Eat and drink as soon as possible after extubation after surgery.

Other:
• Prevent Thrombosis
Actively prevent thrombosis after surgery.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of AnHui Medical University	Hefei	Anhui
China	Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai
China	Shanghai Chest Hospital Affiliated to Shanghai Jiaotong University	Shanghai	Shanghai
China	Zhongshan Hospital Affiliated to Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of hospital stay		Within 1 month after surgery
Secondary	Duration of mechanical ventilation after surgery		Within 1 week after surgery
Secondary	Length of ICU stay		Within 1 month after surgery
Secondary	Mortality		Within 1 month after surgery
Secondary	Overall hospitalization costs		Within 3 months after surgery