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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04642274
Other study ID # ERAS in CS
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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