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

Study Overview
=================
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.

Official Title
-----------------
The Safety and Efficacy of the Enhanced Recovery After Surgery(ERAS) Applied on Cardiac Surgery With Cardiopulmonary Bypass: a Single Center, Randomized, Controlled Clinical Study

Conditions
-----------------
Valvular Heart Disease

Intervention / 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: Conventional control group
* Procedure: ERAS group
* Procedure: Conventional control group
* Procedure: Conventional control group
* Procedure: Conventional control group
* Procedure: Conventional control group
* Procedure: Conventional control group
* Procedure: Conventional control group


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ERAS group<br>Perioperative management follows the Enhanced Recovery after Surgery（ERAS） program | Procedure: ERAS group<br>* Intravenous infusion of flucloxacillin sodium 1g an hour before operation<br>* Other names: yifen®,Flucloxacillin;Procedure: ERAS group<br>* No routine bowel preparation; Normal eating 1 days before the operation; No drinking 2h and solid food 6h before the operation; Drink 10% glucose 250ml 3h before operation ; Gastric mucosal protective agent was given 3 days before operation(Esomeprazole Magnesium Enteric-coated tablets 40mg/d);<br>Procedure: ERAS group<br>* Emphasize the preoperative psychological preparation for patients.<br>Procedure: ERAS group<br>* Received subcutaneous recombinant human erythropoietin (rhEPO)150（international unit/kg） once very two days from 2 days after hospital admission to 5 days postoperatively；<br>* Other names: Recombinant Human Erythropoietin;Procedure: ERAS group<br>* No scopolamine and morphine before surgery; No midazolam; No anti - choline drugs;<br>Procedure: ERAS group<br>* Solu-Medrol®:5mg/kg intravenous infusion during the surgery;<br>* Other names: Methylprednisolone，Solu-Medrol® ;Procedure: ERAS group<br>* Apply Transesophageal Echocardiography（TEE）after anesthesia induction; Goal-directed fluid management.<br>Procedure: ERAS group<br>* Infusion of Human Albumin Grifol®20% 50ml; Ultrafiltration(TERUMO CARDIOVASCULAR SYSTEMS (TERUMO®)); Shorten the Cardio-pulmonary Bypass line； Continuous near infrared spectrum monitoring of cerebral oxygen saturation(MNIR-P100（chongqingmingxi®）)<br>* Other names: Cardio-pulmonary Bypass measures, during the surgery;Procedure: ERAS group<br>* Monitor urine volume closely, over 0.5ml/kg·h.<br>* Other names: Kidney protection measure during the surgery;Procedure: ERAS group<br>* Protective ventilation strategy：Low tidal volume about 6 8ml/kg and positive end expiratory pressure（PEEP） combined with lung recruitment maneuver<br>* Other names: Lung protection measure during the surgery（Dräger Primus）;Procedure: ERAS group<br>* Bilateral thoracic paravertebral block before induction of anesthesia; Fast channel anesthesia: Induction use Sufentanil 0.5 1ug/kg, Vecuronium for Injection 0.15mg/kg and Etomidate 0.2 0.6mg/kg; ②. Maintain use Remifentanil Hydrochloride for Injection 0.1 0.4ug/kg·min, Propofol Injection 2 6mg/kg·h, Sevoflurane 0.5 1.5（minimum alveolar concentration） and Infusing Dexmedetomidine which load dose 0.5μg/kg in 10min then changed into 0.5-1.0μg/kg·h,Vecuronium 0.06 0.12mg/kg·h; ③. Intravenous hydromorphone Hydrochloride Injection 0.15mg/kg before surgery over.<br>* Other names: Anesthesia drugs during the surgery;Procedure: ERAS group<br>* Drink water after 6h, 200ml once, 2 3 times / day， early ambulation，mobilization within 48 h, Intravenous the conventional antiemetic drugs Tropisetron hydrochloride Injection 12mg qd； Intravenous the lansoprazole 30mg q12h.<br>* Other names: Gastrointestinal protection measures after the surgery;Procedure: ERAS group<br>* After operation use Ropivacaine 100mg infiltrating intercostal wound and self-controlled intravenous analgesia pump is applicable(Sufentanil 0.05ug/kg·h combine with Ketamine 40ug/kg·h).<br>* Other names: Analgesia drugs after the surgery;|
| Experimental: Conventional control group<br>Perioperative management follows the conventional program | Procedure: ERAS group<br>* Protective ventilation strategy：Low tidal volume about 6 8ml/kg and positive end expiratory pressure（PEEP） combined with lung recruitment maneuver<br>* Other names: Lung protection measure during the surgery（Dräger Primus）;Procedure: Conventional control group<br>* Routine preoperative psychological preparation for patients.<br>Procedure: Conventional control group<br>* Routine bowel preparation; Liquid food eating 2 days before the operation;<br>Procedure: Conventional control group<br>* Intramuscular injection of scopolamine 0.3mg combined with morphine 10mg before surgery;<br>* Other names: scopolamine and morphine;Procedure: Conventional control group<br>* Induction use Sufentanil 0.5 1ug/kg, Vecuronium 0.15mg/kg and Etomidate 0.2 0.6mg/kg,Midazolam0.05 0.1mg/kg ; Maintain use Sufentanil 1 2ug/kg·h, Propofol 4 12mg/kg·h, Sevoflurane 1 3(minimal alveolar concentration)， Vecuronium 0.06 0.12mg/kg·h;<br>* Other names: Routine use of anesthesia medicine during the surgery;Procedure: Conventional control group<br>* Use self-controlled intravenous analgesia pump containing Sufentanil 0.07ug/kg·h<br>* Other names: Routine use of anesthesia medicine after the surgery;Procedure: Conventional control group<br>* Intravenous infusion of dexamethasone 20mg during the surgery<br>* Other names: Dexamethasone;Procedure: Conventional control group<br>* Intravenous infusion of flucloxacillin sodium 1g before the operation<br>* Other names: yifen®,Flucloxacillin;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The postoperative hospital time |  | From pre-surgery to discharge, up to 4 weeks | 
| Length of ICU stay |  | From entering the ICU to roll out, up to 4 weeks | 
| The time of readiness to discharge |  | From pre-surgery to discharge, up to 4 weeks | 
| The length of hospital stay |  | From pre-surgery to discharge, up to 8 weeks | 
| Hospitalization cost |  | When the patient is discharged | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perioperative major adverse events |  | From pre-surgery to discharge, up to 4 weeks | 
| Vasoactive drugs Support Hours |  | From the start of drugs to stop them, up to 4 weeks | 
| Postoperative tracheal tube time |  | From the end of surgery to the removal of tracheal tube, up to 4 weeks | 
| Duration of mechanical ventilation after surgery |  | From the end of surgery to the recovery of spontaneous breathing, up to 4 weeks | 
| Time to first bowel movement |  | From the end of surgery to first exhaust, up to 2 weeks | 
| Postoperative time to first exhaust |  | From the end of surgery to first exhaust, up to 2 weeks | 
| Hemoglobin | 1day before and 1-5days after operation | baseline and 5 days after operation | 
| C-reactive protein | 1day before and 1-5days after operation | baseline and 5 days after operation | 
| Procalcitonin | 1day before and 1-5days after operation | baseline and 5 days after operation | 
| N-terminal B-type natriuretic peptide（NT-proBNP) | 1day before and 1-5days after operation | baseline and 5 days after operation | 
| Serum Creatinine | 1day before and 1-5days after operation | baseline and 5 days after operation | 
| Troponin I | 1day before and 1-5days after operation | baseline and 5 days after operation | 
| Erythrocyte Sedimentation Rate | 1day before and 1-5days after operation | baseline and 5 days after operation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Enhanced Recovery after Surgery