Clinical trial NCT02479581: The Safety and Efficacy of the Enhanced Recovery After Surgery(ERAS)Applied on Cardiac Surgery With Cardiopulmonary Bypass
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Valvular Heart Disease
Keywords: Enhanced Recovery after Surgery
Lead sponsor: Xiangya Hospital of Central South University
Sponsor class: OTHER
First posted: 2015-06-24
Enrollment: 226
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: The postoperative hospital time
timeFrame: From pre-surgery to discharge, up to 4 weeks
measure: Length of ICU stay
timeFrame: From entering the ICU to roll out, up to 4 weeks
measure: The time of readiness to discharge
timeFrame: From pre-surgery to discharge, up to 4 weeks
measure: The length of hospital stay
timeFrame: From pre-surgery to discharge, up to 8 weeks
measure: Hospitalization cost
timeFrame: When the patient is discharged
Secondary outcomes:
measure: Perioperative major adverse events
timeFrame: From pre-surgery to discharge, up to 4 weeks
measure: Vasoactive drugs Support Hours
timeFrame: From the start of drugs to stop them, up to 4 weeks
measure: Postoperative tracheal tube time
timeFrame: From the end of surgery to the removal of tracheal tube, up to 4 weeks
measure: Duration of mechanical ventilation after surgery
timeFrame: From the end of surgery to the recovery of spontaneous breathing, up to 4 weeks
measure: Time to first bowel movement
timeFrame: From the end of surgery to first exhaust, up to 2 weeks
measure: Postoperative time to first exhaust
timeFrame: From the end of surgery to first exhaust, up to 2 weeks
measure: Hemoglobin
timeFrame: baseline and 5 days after operation
measure: C-reactive protein
timeFrame: baseline and 5 days after operation
measure: Procalcitonin
timeFrame: baseline and 5 days after operation
measure: N-terminal B-type natriuretic peptide（NT-proBNP)
timeFrame: baseline and 5 days after operation
measure: Serum Creatinine
timeFrame: baseline and 5 days after operation
measure: Troponin I
timeFrame: baseline and 5 days after operation
measure: Erythrocyte Sedimentation Rate
timeFrame: baseline and 5 days after operation
Other outcomes:
measure: Questions to the participants' health
timeFrame: Six month
Locations:
city: Changsha
country: China
facility: Xiangya Hospital of Central South University
state: Hunan
Study officials:
affiliation: Xiangya Hospital of Central South University
name: e wang, phD
role: STUDY_DIRECTOR
References:
citation: 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 Mar 16.
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.
citation: Kehlet H, Dahl JB. Anaesthesia, surgery, and challenges in postoperative recovery. Lancet. 2003 Dec 6;362(9399):1921-8. doi: 10.1016/S0140-6736(03)14966-5.
citation: Li M, Zhang J, Gan TJ, Qin G, Wang L, Zhu M, Zhang Z, Pan Y, Ye Z, Zhang F, Chen X, Lin G, Huang L, Luo W, Guo Q, Wang E. Enhanced recovery after surgery pathway for patients undergoing cardiac surgery: a randomized clinical trial. Eur J Cardiothorac Surg. 2018 Sep 1;54(3):491-497. doi: 10.1093/ejcts/ezy100.