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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 glucose

Blood Lactic Acid

Hemoglobin

Albumin

C-reactive protein

Erythrocyte Sedimentation Rate

Serum Creatinine

Troponin I

N-terminal B-type natriuretic peptideļ¼ˆNT-proBNP)

White Blood Cell

Neutrophil

Secondary outcome:

Perioperative major adverse events

Perioperative 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

Page last updated: August 23, 2015

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