The Safety and Efficacy of the Enhanced Recovery After Surgery(ERAS)Applied on Cardiac Surgery With Cardiopulmonary Bypass
Information source: Xiangya Hospital of Central South University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Valvular Heart Disease
Intervention: 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 (Procedure)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: Xiangya Hospital of Central South University Official(s) and/or principal investigator(s): e wang, phD, Study Director, Affiliation: Xiangya Hospital of Central South University
Overall contact: e wang, phD, Phone: +86 731 84327413, Email: ewang324@hotmail.com
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Fasting blood glucoseBlood Lactic Acid Hemoglobin Albumin C-reactive protein Erythrocyte Sedimentation Rate Serum Creatinine Troponin I N-terminal B-type natriuretic peptideļ¼NT-proBNP) White Blood Cell Neutrophil
Secondary outcome: Perioperative major adverse eventsPerioperative use of the species of vasoactive drug Vasoactive drugs Support Hours Time after deactivation of vasoactive drugs Postoperative tracheal tube time Duration of mechanical ventilation after surgery The time after the ICU until discharge Length of ICU stay Recovery time Time to first bowel movement Postoperative time to first exhaust Postoperative to normal eating time The total length of hospital stay
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
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
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.
Locations and Contacts
e wang, phD, Phone: +86 731 84327413, Email: ewang324@hotmail.com
Xiangya Hospital of Central South University, Changsha, Hunan 410078, China; Not yet recruiting e wang, phD, Phone: +86 731 84327413, Email: ewang324@hotmail.com e wang, phD, Principal Investigator
Additional Information
Starting date: July 2015
Last updated: July 19, 2015
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