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

May 31, 2017 updated by: Xiangya Hospital of Central South University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

226

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hunan
      • Changsha, Hunan, China, 410078
        • Xiangya Hospital of Central South University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ERAS group
Perioperative management follows the Enhanced Recovery after Surgery（ERAS） program
Procedure: ERAS group
Intravenous infusion of flucloxacillin sodium 1g an hour before operation
Other Names:
  • "yifen®","Flucloxacillin"
Procedure: ERAS group
  1. No routine bowel preparation;
  2. Normal eating 1 days before the operation;
  3. No drinking 2h and solid food 6h before the operation;
  4. Drink 10% glucose 250ml 3h before operation ;
  5. Gastric mucosal protective agent was given 3 days before operation(Esomeprazole Magnesium Enteric-coated tablets 40mg/d);
Procedure: ERAS group
Emphasize the preoperative psychological preparation for patients.
Procedure: ERAS group
Received subcutaneous recombinant human erythropoietin (rhEPO)150（international unit/kg） once very two days from 2 days after hospital admission to 5 days postoperatively；
Other Names:
  • Recombinant Human Erythropoietin
Procedure: ERAS group
No scopolamine and morphine before surgery; No midazolam; No anti - choline drugs;
Procedure: ERAS group
Solu-Medrol®:5mg/kg intravenous infusion during the surgery;
Other Names:
  • "Methylprednisolone"，"Solu-Medrol® "
Procedure: ERAS group
  1. Apply Transesophageal Echocardiography（TEE）after anesthesia induction;
  2. Goal-directed fluid management.
Procedure: ERAS group
  1. Infusion of Human Albumin Grifol®20% 50ml;
  2. Ultrafiltration(TERUMO CARDIOVASCULAR SYSTEMS (TERUMO®));
  3. Shorten the Cardio-pulmonary Bypass line；
  4. Continuous near infrared spectrum monitoring of cerebral oxygen saturation(MNIR-P100（chongqingmingxi®）)
Other Names:
  • Cardio-pulmonary Bypass measures, during the surgery
Procedure: ERAS group
Monitor urine volume closely, over 0.5ml/kg·h.
Other Names:
  • Kidney protection measure during the surgery
Procedure: ERAS group
Protective ventilation strategy：Low tidal volume about 6~8ml/kg and positive end expiratory pressure（PEEP） combined with lung recruitment maneuver
Other Names:
  • Lung protection measure during the surgery（Dräger Primus）
Procedure: ERAS group
  1. Bilateral thoracic paravertebral block before induction of anesthesia;

  2. 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.
Other Names:
  • Anesthesia drugs during the surgery
Procedure: ERAS group
  1. Drink water after 6h, 200ml once, 2~3 times / day，
  2. early ambulation，mobilization within 48 h,
  3. Intravenous the conventional antiemetic drugs Tropisetron hydrochloride Injection 12mg qd；
  4. Intravenous the lansoprazole 30mg q12h.
Other Names:
  • Gastrointestinal protection measures after the surgery
Procedure: ERAS group
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).
Other Names:
  • Analgesia drugs after the surgery
Experimental: Conventional control group
Perioperative management follows the conventional program
Procedure: ERAS group
Intravenous infusion of flucloxacillin sodium 1g an hour before operation
Other Names:
  • "yifen®","Flucloxacillin"
Procedure: ERAS group
  1. No routine bowel preparation;
  2. Normal eating 1 days before the operation;
  3. No drinking 2h and solid food 6h before the operation;
  4. Drink 10% glucose 250ml 3h before operation ;
  5. Gastric mucosal protective agent was given 3 days before operation(Esomeprazole Magnesium Enteric-coated tablets 40mg/d);
Procedure: ERAS group
Emphasize the preoperative psychological preparation for patients.
Procedure: ERAS group
Received subcutaneous recombinant human erythropoietin (rhEPO)150（international unit/kg） once very two days from 2 days after hospital admission to 5 days postoperatively；
Other Names:
  • Recombinant Human Erythropoietin
Procedure: ERAS group
No scopolamine and morphine before surgery; No midazolam; No anti - choline drugs;
Procedure: ERAS group
Solu-Medrol®:5mg/kg intravenous infusion during the surgery;
Other Names:
  • "Methylprednisolone"，"Solu-Medrol® "
Procedure: ERAS group
  1. Apply Transesophageal Echocardiography（TEE）after anesthesia induction;
  2. Goal-directed fluid management.
Procedure: ERAS group
  1. Infusion of Human Albumin Grifol®20% 50ml;
  2. Ultrafiltration(TERUMO CARDIOVASCULAR SYSTEMS (TERUMO®));
  3. Shorten the Cardio-pulmonary Bypass line；
  4. Continuous near infrared spectrum monitoring of cerebral oxygen saturation(MNIR-P100（chongqingmingxi®）)
Other Names:
  • Cardio-pulmonary Bypass measures, during the surgery
Procedure: ERAS group
Monitor urine volume closely, over 0.5ml/kg·h.
Other Names:
  • Kidney protection measure during the surgery
Procedure: ERAS group
Protective ventilation strategy：Low tidal volume about 6~8ml/kg and positive end expiratory pressure（PEEP） combined with lung recruitment maneuver
Other Names:
  • Lung protection measure during the surgery（Dräger Primus）
Procedure: ERAS group
  1. Bilateral thoracic paravertebral block before induction of anesthesia;

  2. 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.
Other Names:
  • Anesthesia drugs during the surgery
Procedure: ERAS group
  1. Drink water after 6h, 200ml once, 2~3 times / day，
  2. early ambulation，mobilization within 48 h,
  3. Intravenous the conventional antiemetic drugs Tropisetron hydrochloride Injection 12mg qd；
  4. Intravenous the lansoprazole 30mg q12h.
Other Names:
  • Gastrointestinal protection measures after the surgery
Procedure: ERAS group
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).
Other Names:
  • Analgesia drugs after the surgery
Procedure: Conventional control group
Routine preoperative psychological preparation for patients.
Procedure: Conventional control group
  1. Routine bowel preparation;
  2. Liquid food eating 2 days before the operation;
Procedure: Conventional control group
Intramuscular injection of scopolamine 0.3mg combined with morphine 10mg before surgery;
Other Names:
  • scopolamine and morphine
Procedure: Conventional control group
  1. Induction use Sufentanil 0.5~1ug/kg, Vecuronium 0.15mg/kg and Etomidate 0.2~0.6mg/kg,Midazolam0.05~0.1mg/kg ;
  2. 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;
Other Names:
  • Routine use of anesthesia medicine during the surgery
Procedure: Conventional control group
Use self-controlled intravenous analgesia pump containing Sufentanil 0.07ug/kg·h
Other Names:
  • Routine use of anesthesia medicine after the surgery
Procedure: Conventional control group
Intravenous infusion of dexamethasone 20mg during the surgery
Other Names:
  • Dexamethasone
Procedure: Conventional control group
Intravenous infusion of flucloxacillin sodium 1g before the operation
Other Names:
  • "yifen®","Flucloxacillin"

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The postoperative hospital time
Time Frame: From pre-surgery to discharge, up to 4 weeks
From pre-surgery to discharge, up to 4 weeks
Length of ICU stay
Time Frame: From entering the ICU to roll out, up to 4 weeks
From entering the ICU to roll out, up to 4 weeks
The time of readiness to discharge
Time Frame: From pre-surgery to discharge, up to 4 weeks
From pre-surgery to discharge, up to 4 weeks
The length of hospital stay
Time Frame: From pre-surgery to discharge, up to 8 weeks
From pre-surgery to discharge, up to 8 weeks
Hospitalization cost
Time Frame: When the patient is discharged
When the patient is discharged

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perioperative major adverse events
Time Frame: From pre-surgery to discharge, up to 4 weeks
From pre-surgery to discharge, up to 4 weeks
Vasoactive drugs Support Hours
Time Frame: From the start of drugs to stop them, up to 4 weeks
From the start of drugs to stop them, up to 4 weeks
Postoperative tracheal tube time
Time Frame: From the end of surgery to the removal of tracheal tube, up to 4 weeks
From the end of surgery to the removal of tracheal tube, up to 4 weeks
Duration of mechanical ventilation after surgery
Time Frame: From the end of surgery to the recovery of spontaneous breathing, up to 4 weeks
From the end of surgery to the recovery of spontaneous breathing, up to 4 weeks
Time to first bowel movement
Time Frame: From the end of surgery to first exhaust, up to 2 weeks
From the end of surgery to first exhaust, up to 2 weeks
Postoperative time to first exhaust
Time Frame: From the end of surgery to first exhaust, up to 2 weeks
From the end of surgery to first exhaust, up to 2 weeks
Hemoglobin
Time Frame: baseline and 5 days after operation
1day before and 1-5days after operation
baseline and 5 days after operation
C-reactive protein
Time Frame: baseline and 5 days after operation
1day before and 1-5days after operation
baseline and 5 days after operation
Procalcitonin
Time Frame: baseline and 5 days after operation
1day before and 1-5days after operation
baseline and 5 days after operation
N-terminal B-type natriuretic peptide（NT-proBNP)
Time Frame: baseline and 5 days after operation
1day before and 1-5days after operation
baseline and 5 days after operation
Serum Creatinine
Time Frame: baseline and 5 days after operation
1day before and 1-5days after operation
baseline and 5 days after operation
Troponin I
Time Frame: baseline and 5 days after operation
1day before and 1-5days after operation
baseline and 5 days after operation
Erythrocyte Sedimentation Rate
Time Frame: baseline and 5 days after operation
1day before and 1-5days after operation
baseline and 5 days after operation

Other Outcome Measures

Outcome Measure
Time Frame
Questions to the participants' health
Time Frame: Six month
Six month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xiangya Hospital of Central South University

Investigators

  • Study Director: e wang, phD, Xiangya Hospital of Central South University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2015

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

May 1, 2017

Study Registration Dates

First Submitted

June 12, 2015

First Submitted That Met QC Criteria

June 19, 2015

First Posted (Estimate)

June 24, 2015

Study Record Updates

Last Update Posted (Actual)

June 1, 2017

Last Update Submitted That Met QC Criteria

May 31, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • liman20150516

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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