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The Safety and Efficacy of the Enhanced Recovery After Surgery(ERAS)Applied on Cardiac Surgery With Cardiopulmonary Bypass (ERAS)

Primary Purpose

Valvular Heart Disease

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
ERAS group
ERAS group
ERAS group
ERAS group
ERAS group
ERAS group
ERAS group
ERAS group
ERAS group
ERAS group
ERAS group
ERAS group
Conventional control group
ERAS group
Conventional control group
Conventional control group
Conventional control group
Conventional control group
Conventional control group
Conventional control group
Sponsored by
Xiangya Hospital of Central South University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Valvular Heart Disease focused on measuring Enhanced Recovery after Surgery

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Xiangya Hospital of Central South University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

ERAS group

Conventional control group

Arm Description

Perioperative management follows the Enhanced Recovery after Surgery（ERAS） program

Perioperative management follows the conventional program

Outcomes

Primary Outcome Measures

The postoperative hospital time
Length of ICU stay
The time of readiness to discharge
The length of hospital stay
Hospitalization cost

Secondary Outcome Measures

Perioperative major adverse events
Vasoactive drugs Support Hours
Postoperative tracheal tube time
Duration of mechanical ventilation after surgery
Time to first bowel movement
Postoperative time to first exhaust
Hemoglobin
1day before and 1-5days after operation
C-reactive protein
1day before and 1-5days after operation
Procalcitonin
1day before and 1-5days after operation
N-terminal B-type natriuretic peptide（NT-proBNP)
1day before and 1-5days after operation
Serum Creatinine
1day before and 1-5days after operation
Troponin I
1day before and 1-5days after operation
Erythrocyte Sedimentation Rate
1day before and 1-5days after operation

Full Information

First Posted
June 12, 2015
Last Updated
May 31, 2017
Sponsor
Xiangya Hospital of Central South University
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1. Study Identification

Unique Protocol Identification Number
NCT02479581
Brief Title
The Safety and Efficacy of the Enhanced Recovery After Surgery(ERAS)Applied on Cardiac Surgery With Cardiopulmonary Bypass
Acronym
ERAS
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

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
July 2015 (Actual)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
May 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xiangya Hospital of Central South University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Valvular Heart Disease
Keywords
Enhanced Recovery after Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
226 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ERAS group
Arm Type
Experimental
Arm Description
Perioperative management follows the Enhanced Recovery after Surgery（ERAS） program
Arm Title
Conventional control group
Arm Type
Experimental
Arm Description
Perioperative management follows the conventional program
Intervention Type
Procedure
Intervention Name(s)
ERAS group
Other Intervention Name(s)
"yifen®","Flucloxacillin"
Intervention Description
Intravenous infusion of flucloxacillin sodium 1g an hour before operation
Intervention Type
Procedure
Intervention Name(s)
ERAS group
Intervention Description
No routine bowel preparation; Normal eating 1 days before the operation; No drinking 2h and solid food 6h before the operation; Drink 10% glucose 250ml 3h before operation ; Gastric mucosal protective agent was given 3 days before operation(Esomeprazole Magnesium Enteric-coated tablets 40mg/d);
Intervention Type
Procedure
Intervention Name(s)
ERAS group
Intervention Description
Emphasize the preoperative psychological preparation for patients.
Intervention Type
Procedure
Intervention Name(s)
ERAS group
Other Intervention Name(s)
Recombinant Human Erythropoietin
Intervention Description
Received subcutaneous recombinant human erythropoietin (rhEPO)150（international unit/kg） once very two days from 2 days after hospital admission to 5 days postoperatively；
Intervention Type
Procedure
Intervention Name(s)
ERAS group
Intervention Description
No scopolamine and morphine before surgery; No midazolam; No anti - choline drugs;
Intervention Type
Procedure
Intervention Name(s)
ERAS group
Other Intervention Name(s)
"Methylprednisolone"，"Solu-Medrol® "
Intervention Description
Solu-Medrol®:5mg/kg intravenous infusion during the surgery;
Intervention Type
Procedure
Intervention Name(s)
ERAS group
Intervention Description
Apply Transesophageal Echocardiography（TEE）after anesthesia induction; Goal-directed fluid management.
Intervention Type
Procedure
Intervention Name(s)
ERAS group
Other Intervention Name(s)
Cardio-pulmonary Bypass measures, during the surgery
Intervention Description
Infusion of Human Albumin Grifol®20% 50ml; Ultrafiltration(TERUMO CARDIOVASCULAR SYSTEMS (TERUMO®)); Shorten the Cardio-pulmonary Bypass line； Continuous near infrared spectrum monitoring of cerebral oxygen saturation(MNIR-P100（chongqingmingxi®）)
Intervention Type
Procedure
Intervention Name(s)
ERAS group
Other Intervention Name(s)
Kidney protection measure during the surgery
Intervention Description
Monitor urine volume closely, over 0.5ml/kg·h.
Intervention Type
Procedure
Intervention Name(s)
ERAS group
Other Intervention Name(s)
Lung protection measure during the surgery（Dräger Primus）
Intervention Description
Protective ventilation strategy：Low tidal volume about 6~8ml/kg and positive end expiratory pressure（PEEP） combined with lung recruitment maneuver
Intervention Type
Procedure
Intervention Name(s)
ERAS group
Other Intervention Name(s)
Anesthesia drugs during the surgery
Intervention Description
Bilateral thoracic paravertebral block before induction of anesthesia; Fast channel anesthesia: Induction use Sufentanil 0.5~1ug/kg, Vecuronium for Injection 0.15mg/kg and Etomidate 0.2~0.6mg/kg; ②. Maintain use Remifentanil Hydrochloride for Injection 0.1~0.4ug/kg·min, Propofol Injection 2~6mg/kg·h, Sevoflurane 0.5~1.5（minimum alveolar concentration） and Infusing Dexmedetomidine which load dose 0.5μg/kg in 10min then changed into 0.5-1.0μg/kg·h,Vecuronium 0.06~0.12mg/kg·h; ③. Intravenous hydromorphone Hydrochloride Injection 0.15mg/kg before surgery over.
Intervention Type
Procedure
Intervention Name(s)
ERAS group
Other Intervention Name(s)
Gastrointestinal protection measures after the surgery
Intervention Description
Drink water after 6h, 200ml once, 2~3 times / day， early ambulation，mobilization within 48 h, Intravenous the conventional antiemetic drugs Tropisetron hydrochloride Injection 12mg qd； Intravenous the lansoprazole 30mg q12h.
Intervention Type
Procedure
Intervention Name(s)
Conventional control group
Intervention Description
Routine preoperative psychological preparation for patients.
Intervention Type
Procedure
Intervention Name(s)
ERAS group
Other Intervention Name(s)
Analgesia drugs after the surgery
Intervention Description
After operation use Ropivacaine 100mg infiltrating intercostal wound and self-controlled intravenous analgesia pump is applicable(Sufentanil 0.05ug/kg·h combine with Ketamine 40ug/kg·h).
Intervention Type
Procedure
Intervention Name(s)
Conventional control group
Intervention Description
Routine bowel preparation; Liquid food eating 2 days before the operation;
Intervention Type
Procedure
Intervention Name(s)
Conventional control group
Other Intervention Name(s)
scopolamine and morphine
Intervention Description
Intramuscular injection of scopolamine 0.3mg combined with morphine 10mg before surgery;
Intervention Type
Procedure
Intervention Name(s)
Conventional control group
Other Intervention Name(s)
Routine use of anesthesia medicine during the surgery
Intervention Description
Induction use Sufentanil 0.5~1ug/kg, Vecuronium 0.15mg/kg and Etomidate 0.2~0.6mg/kg,Midazolam0.05~0.1mg/kg ; Maintain use Sufentanil 1~2ug/kg·h, Propofol 4~12mg/kg·h, Sevoflurane 1~3(minimal alveolar concentration)， Vecuronium 0.06~0.12mg/kg·h;
Intervention Type
Procedure
Intervention Name(s)
Conventional control group
Other Intervention Name(s)
Routine use of anesthesia medicine after the surgery
Intervention Description
Use self-controlled intravenous analgesia pump containing Sufentanil 0.07ug/kg·h
Intervention Type
Procedure
Intervention Name(s)
Conventional control group
Other Intervention Name(s)
Dexamethasone
Intervention Description
Intravenous infusion of dexamethasone 20mg during the surgery
Intervention Type
Procedure
Intervention Name(s)
Conventional control group
Other Intervention Name(s)
"yifen®","Flucloxacillin"
Intervention Description
Intravenous infusion of flucloxacillin sodium 1g before the operation
Primary Outcome Measure Information:
Title
The postoperative hospital time
Time Frame
From pre-surgery to discharge, up to 4 weeks
Title
Length of ICU stay
Time Frame
From entering the ICU to roll out, up to 4 weeks
Title
The time of readiness to discharge
Time Frame
From pre-surgery to discharge, up to 4 weeks
Title
The length of hospital stay
Time Frame
From pre-surgery to discharge, up to 8 weeks
Title
Hospitalization cost
Time Frame
When the patient is discharged
Secondary Outcome Measure Information:
Title
Perioperative major adverse events
Time Frame
From pre-surgery to discharge, up to 4 weeks
Title
Vasoactive drugs Support Hours
Time Frame
From the start of drugs to stop them, up to 4 weeks
Title
Postoperative tracheal tube time
Time Frame
From the end of surgery to the removal of tracheal tube, up to 4 weeks
Title
Duration of mechanical ventilation after surgery
Time Frame
From the end of surgery to the recovery of spontaneous breathing, up to 4 weeks
Title
Time to first bowel movement
Time Frame
From the end of surgery to first exhaust, up to 2 weeks
Title
Postoperative time to first exhaust
Time Frame
From the end of surgery to first exhaust, up to 2 weeks
Title
Hemoglobin
Description
1day before and 1-5days after operation
Time Frame
baseline and 5 days after operation
Title
C-reactive protein
Description
1day before and 1-5days after operation
Time Frame
baseline and 5 days after operation
Title
Procalcitonin
Description
1day before and 1-5days after operation
Time Frame
baseline and 5 days after operation
Title
N-terminal B-type natriuretic peptide（NT-proBNP)
Description
1day before and 1-5days after operation
Time Frame
baseline and 5 days after operation
Title
Serum Creatinine
Description
1day before and 1-5days after operation
Time Frame
baseline and 5 days after operation
Title
Troponin I
Description
1day before and 1-5days after operation
Time Frame
baseline and 5 days after operation
Title
Erythrocyte Sedimentation Rate
Description
1day before and 1-5days after operation
Time Frame
baseline and 5 days after operation
Other Pre-specified Outcome Measures:
Title
Questions to the participants' health
Time Frame
Six month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
e wang, phD
Organizational Affiliation
Xiangya Hospital of Central South University
Official's Role
Study Director
Facility Information:
Facility Name
Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410078
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
25791027
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.
Results Reference
result
PubMed Identifier
22797672
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.
Results Reference
result
PubMed Identifier
14667752
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.
Results Reference
result
PubMed Identifier
29514224
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.
Results Reference
derived

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The Safety and Efficacy of the Enhanced Recovery After Surgery(ERAS)Applied on Cardiac Surgery With Cardiopulmonary Bypass

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