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

Valvular Heart Disease Clinical Trial

— ERAS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02479581
• Other study ID #: liman20150516
• Status: Completed
• Phase: Phase 2
• First received: June 12, 2015
• Last updated: May 31, 2017
• Start date: July 2015
• Est. completion date: May 2017

Study information

• Verified date: February 2017
• Source: Xiangya Hospital of Central South University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 226
• Est. completion date: May 2017
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Heart Diseases
• Heart Valve Diseases
• Valvular Heart Disease

Intervention

Procedure:
• ERAS group
Intravenous infusion of flucloxacillin sodium 1g an hour before operation
• ERAS group
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);
• ERAS group
Emphasize the preoperative psychological preparation for patients.
• ERAS group
Received subcutaneous recombinant human erythropoietin (rhEPO)150(international unit/kg) once very two days from 2 days after hospital admission to 5 days postoperatively;
• ERAS group
No scopolamine and morphine before surgery; No midazolam; No anti - choline drugs;
• ERAS group
Solu-Medrol®:5mg/kg intravenous infusion during the surgery;
• ERAS group
Apply Transesophageal Echocardiography(TEE)after anesthesia induction; Goal-directed fluid management.
• ERAS group
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®))
• ERAS group
Monitor urine volume closely, over 0.5ml/kg·h.
• ERAS group
Protective ventilation strategy:Low tidal volume about 6~8ml/kg and positive end expiratory pressure(PEEP) combined with lung recruitment maneuver
• ERAS group
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; ?. 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; ?. Intravenous hydromorphone Hydrochloride Injection 0.15mg/kg before surgery over.
• ERAS group
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.
• Conventional control group
Routine preoperative psychological preparation for patients.
• ERAS group
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).
• Conventional control group
Routine bowel preparation; Liquid food eating 2 days before the operation;
• Conventional control group
Intramuscular injection of scopolamine 0.3mg combined with morphine 10mg before surgery;
• Conventional control group
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;
• Conventional control group
Use self-controlled intravenous analgesia pump containing Sufentanil 0.07ug/kg·h
• Conventional control group
Intravenous infusion of dexamethasone 20mg during the surgery
• Conventional control group
Intravenous infusion of flucloxacillin sodium 1g before the operation

Locations

Country	Name	City	State
China	Xiangya Hospital of Central South University	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Xiangya Hospital of Central South University

Country where clinical trial is conducted

China, 

References & Publications (3)

Bakker N, Cakir H, Doodeman HJ, Houdijk AP. Eight years of experience with Enhanced Recovery After Surgery in patients with colon cancer: Impact of measures to improve adherence. Surgery. 2015 Jun;157(6):1130-6. doi: 10.1016/j.surg.2015.01.016. Epub 2015 — View Citation

Hoffmann H, Kettelhack C. Fast-track surgery--conditions and challenges in postsurgical treatment: a review of elements of translational research in enhanced recovery after surgery. Eur Surg Res. 2012;49(1):24-34. doi: 10.1159/000339859. Epub 2012 Jul 11. — View Citation

Kehlet H, Dahl JB. Anaesthesia, surgery, and challenges in postoperative recovery. Lancet. 2003 Dec 6;362(9399):1921-8. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Questions to the participants' health		Six month
Primary	The postoperative hospital time		From pre-surgery to discharge, up to 4 weeks
Primary	Length of ICU stay		From entering the ICU to roll out, up to 4 weeks
Primary	The time of readiness to discharge		From pre-surgery to discharge, up to 4 weeks
Primary	The length of hospital stay		From pre-surgery to discharge, up to 8 weeks
Primary	Hospitalization cost		When the patient is discharged
Secondary	Perioperative major adverse events		From pre-surgery to discharge, up to 4 weeks
Secondary	Vasoactive drugs Support Hours		From the start of drugs to stop them, up to 4 weeks
Secondary	Postoperative tracheal tube time		From the end of surgery to the removal of tracheal tube, up to 4 weeks
Secondary	Duration of mechanical ventilation after surgery		From the end of surgery to the recovery of spontaneous breathing, up to 4 weeks
Secondary	Time to first bowel movement		From the end of surgery to first exhaust, up to 2 weeks
Secondary	Postoperative time to first exhaust		From the end of surgery to first exhaust, up to 2 weeks
Secondary	Hemoglobin	1day before and 1-5days after operation	baseline and 5 days after operation
Secondary	C-reactive protein	1day before and 1-5days after operation	baseline and 5 days after operation
Secondary	Procalcitonin	1day before and 1-5days after operation	baseline and 5 days after operation
Secondary	N-terminal B-type natriuretic peptide(NT-proBNP)	1day before and 1-5days after operation	baseline and 5 days after operation
Secondary	Serum Creatinine	1day before and 1-5days after operation	baseline and 5 days after operation
Secondary	Troponin I	1day before and 1-5days after operation	baseline and 5 days after operation
Secondary	Erythrocyte Sedimentation Rate	1day before and 1-5days after operation	baseline and 5 days after operation