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The Impact of ERAS Program in Cardiac Surgery on Patient Prognosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04642274
Recruitment Status : Not yet recruiting
First Posted : November 24, 2020
Last Update Posted : November 24, 2020
Sponsor:
Information provided by (Responsible Party):
Shanghai Zhongshan Hospital

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

Condition or disease Intervention/treatment Phase
ERAS Other: Nutrition Other: Control Blood Glucose Drug: Fasting Behavioral: Smoking and Alcohol Other: Control Anemia Other: Blood Transfusion Other: GDFT Other: Remove the tracheal tube Behavioral: Eating and Drinking Other: Prevent Thrombosis Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Impact of ERAS Program in Cardiac Surgery on Patient Prognosis
Estimated Study Start Date : January 1, 2021
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Arm Intervention/treatment
Experimental: ERAS Other: Nutrition
Correct the patient's low nutritional status before surgery.

Other: 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

Other: Blood Transfusion
Use strict blood transfusion indications and blood protection strategy during surgery.

Other: GDFT
Use goal-directed fluid therapy during surgery.

Other: 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.

No Intervention: Control



Primary Outcome Measures :
  1. Length of hospital stay [ Time Frame: Within 1 month after surgery ]

Secondary Outcome Measures :
  1. Duration of mechanical ventilation after surgery [ Time Frame: Within 1 week after surgery ]
  2. Length of ICU stay [ Time Frame: Within 1 month after surgery ]
  3. Mortality [ Time Frame: Within 1 month after surgery ]
  4. Overall hospitalization costs [ Time Frame: Within 3 months after surgery ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ASA II/III
  • BMI 18-31 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04642274


Contacts
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Contact: Guo Kefang, MD +86-13817706936 drguokefang@foxmail.com

Sponsors and Collaborators
Shanghai Zhongshan Hospital
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Responsible Party: Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier: NCT04642274    
Other Study ID Numbers: ERAS in CS
First Posted: November 24, 2020    Key Record Dates
Last Update Posted: November 24, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shanghai Zhongshan Hospital:
ERAS
Cardiac surgery