The Safety and Efficacy of the Enhanced Recovery After Surgery(ERAS)Applied on Cardiac Surgery With Cardiopulmonary Bypass
- Conditions
- Valvular Heart Disease
- Interventions
- Procedure: ERAS groupProcedure: Conventional control group
- Registration Number
- NCT02479581
- Lead Sponsor
- Xiangya Hospital of Central South University
- Brief Summary
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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 226
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Conventional control group ERAS group Perioperative management follows the conventional program ERAS group ERAS group Perioperative management follows the Enhanced Recovery after Surgery（ERAS） program Conventional control group Conventional control group Perioperative management follows the conventional program
- Primary Outcome Measures
Name Time Method The length of hospital stay From pre-surgery to discharge, up to 8 weeks The postoperative hospital time From pre-surgery to discharge, up to 4 weeks The time of readiness to discharge From pre-surgery to discharge, up to 4 weeks Length of ICU stay From entering the ICU to roll out, up to 4 weeks Hospitalization cost When the patient is discharged
- Secondary Outcome Measures
Name Time Method C-reactive protein baseline and 5 days after operation 1day before and 1-5days after operation
Serum Creatinine baseline and 5 days after operation 1day before and 1-5days after operation
Postoperative tracheal tube time From the end of surgery to the removal of tracheal tube, up to 4 weeks Time to first bowel movement From the end of surgery to first exhaust, up to 2 weeks Hemoglobin baseline and 5 days after operation 1day before and 1-5days after operation
Troponin I baseline and 5 days after operation 1day before and 1-5days after operation
Perioperative major adverse events From pre-surgery to discharge, up to 4 weeks Procalcitonin baseline and 5 days after operation 1day before and 1-5days after operation
Duration of mechanical ventilation after surgery From the end of surgery to the recovery of spontaneous breathing, up to 4 weeks Postoperative time to first exhaust From the end of surgery to first exhaust, up to 2 weeks Erythrocyte Sedimentation Rate baseline and 5 days after operation 1day before and 1-5days after operation
Vasoactive drugs Support Hours From the start of drugs to stop them, up to 4 weeks N-terminal B-type natriuretic peptide（NT-proBNP) baseline and 5 days after operation 1day before and 1-5days after operation
Trial Locations
- Locations (1)
Xiangya Hospital of Central South University
🇨🇳Changsha, Hunan, China