The Safety and Efficacy of the Enhanced Recovery After Surgery(ERAS)Applied on Cardiac Surgery With Cardiopulmonary Bypass

Central South University

Status and phase: Completed; Phase 2

Conditions: Valvular Heart Disease

Treatments: Procedure: ERAS group; Procedure: Conventional control group

Study type: Interventional

Funder types: Other

Identifiers

NCT02479581

liman20150516

Details and patient eligibility

About

This study evaluates the enhanced recovery after surgery (ERAS) concept over conventional postoperative care in patients with heart valve disease undergoing cardiac surgery with cardiopulmonary bypass. Half of participants will adherence to the ERAS, while the other half will under the conventional postoperative care.

Full description

Enhanced recovery after surgery (ERAS) or fast-track surgery is a perioperative and postoperative care concept initiated in the early 1990s aiming to reduce the length of hospital stays following elective abdominal surgery. The success of ERAS depends highly on multidisciplinary teamwork and patient compliance.

This study intends to compare the Enhanced Recovery After Surgery (ERAS) concept applied to patients with heart valve disease undergoing cardiac surgery with cardiopulmonary bypass under traditional perioperative management of patients, committed to reducing patient's physical and psychological stress by surgical trauma, achieve the purpose of fast recovery, in order to establish an effective perioperative management during cardiopulmonary bypass surgery, improve patients' satisfaction and to accelerate postoperative rehabilitation safely.

Enrollment: 226 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Heart function grade II - III (Using the cardiac function classification method formulated by American Heart Disease Institute)
• The in - hospital was treated with extracorporeal circulation operation and general anesthesia.
• Had a good cognition, and signed the informed consent.
• Aged between 18 and 70.
• The age, clinical examination and other generally situation of the two groups of patients had no statistical significance.

Exclusion criteria

• Combined with other blood coagulation dysfunction, serious brain, liver and kidney dysfunction, endocrine system diseases and serious infectious disease.
• Patients with severe mental disorders cannot cooperate with the treatment.
• Emergency operation
• Have taboo of Echocardiography and pulmonary catheterization by echocardiography.
• Patients have been fitted with a pacemaker.
• Allergic to erythropoietin.
• Suspected or had alcohol, drug abuse history.
• Spinal deformity or paravertebral lesions.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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226 participants in 2 patient groups

ERAS group

Experimental group

Description:

Perioperative management follows the Enhanced Recovery after Surgery（ERAS） program

Treatment:

Procedure: ERAS group

Procedure: ERAS group

Procedure: ERAS group

Procedure: ERAS group

Procedure: ERAS group

Procedure: ERAS group

Procedure: ERAS group

Procedure: ERAS group

Procedure: ERAS group

Procedure: ERAS group

Procedure: ERAS group

Procedure: ERAS group

Procedure: ERAS group

Conventional control group

Experimental group

Description:

Perioperative management follows the conventional program

Treatment:

Procedure: ERAS group

Procedure: ERAS group

Procedure: Conventional control group

Procedure: ERAS group

Procedure: ERAS group

Procedure: ERAS group

Procedure: ERAS group

Procedure: Conventional control group

Procedure: ERAS group

Procedure: Conventional control group

Procedure: ERAS group

Procedure: Conventional control group

Procedure: ERAS group

Procedure: Conventional control group

Procedure: ERAS group

Procedure: ERAS group

Procedure: ERAS group

Procedure: ERAS group

Procedure: Conventional control group

Procedure: Conventional control group