Valvular Heart Disease
Conditions
Keywords
Enhanced Recovery after Surgery
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.
Interventions
PROCEDUREERAS group
Intravenous infusion of flucloxacillin sodium 1g an hour before operation
PROCEDUREConventional control group
Routine preoperative psychological preparation for patients.
Sponsors
Xiangya Hospital of Central South University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hospitalization cost | When the patient is discharged |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | baseline and 5 days after operation | 1day before and 1-5days after operation |
| C-reactive protein | baseline and 5 days after operation | 1day before and 1-5days after operation |
| N-terminal B-type natriuretic peptide（NT-proBNP) | 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 |
| Troponin I | baseline and 5 days after operation | 1day before and 1-5days after operation |
| Erythrocyte Sedimentation Rate | baseline and 5 days after operation | 1day before and 1-5days after operation |
| Procalcitonin | 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 | — |
| Postoperative tracheal tube time | From the end of surgery to the removal of tracheal tube, up to 4 weeks | — |
| Perioperative major adverse events | From pre-surgery to discharge, 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 | — |
Other
| Measure | Time frame |
|---|---|
| Questions to the participants' health | Six month |
Countries
China
Outcome results
None listed