The Safety and Efficacy of the Enhanced Recovery After Surgery(ERAS)Applied on Cardiac Surgery With Cardiopulmonary Bypass
ERAS
1 other identifier
interventional
226
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 12, 2015
CompletedFirst Posted
Study publicly available on registry
June 24, 2015
CompletedStudy Start
First participant enrolled
July 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2017
CompletedJune 1, 2017
February 1, 2017
1.3 years
June 12, 2015
May 31, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
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
Hospitalization cost
When the patient is discharged
Secondary Outcomes (13)
Perioperative major adverse events
From pre-surgery to discharge, up to 4 weeks
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
Duration of mechanical ventilation after surgery
From the end of surgery to the recovery of spontaneous breathing, up to 4 weeks
Time to first bowel movement
From the end of surgery to first exhaust, up to 2 weeks
- +8 more secondary outcomes
Other Outcomes (1)
Questions to the participants' health
Six month
Study Arms (2)
ERAS group
EXPERIMENTALPerioperative management follows the Enhanced Recovery after Surgery（ERAS） program
Conventional control group
EXPERIMENTALPerioperative management follows the conventional program
Interventions
Intravenous infusion of flucloxacillin sodium 1g an hour before operation
Routine preoperative psychological preparation for patients.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Xiangya Hospital of Central South University
Changsha, Hunan, 410078, China
Related Publications (4)
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.
PMID: 25791027RESULTHoffmann 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.
PMID: 22797672RESULTKehlet 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.
PMID: 14667752RESULTLi 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.
PMID: 29514224DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
e wang, phD
Xiangya Hospital of Central South University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 12, 2015
First Posted
June 24, 2015
Study Start
July 1, 2015
Primary Completion
November 1, 2016
Study Completion
May 1, 2017
Last Updated
June 1, 2017
Record last verified: 2017-02