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NCT Number: NCT02479581

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Xiangya Hospital of Central South University

Changsha, Hunan, 410078, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ERAS group

Procedure

Intravenous infusion of flucloxacillin sodium 1g an hour before operation

Other names: "yifen®","Flucloxacillin"

Conventional control group

Procedure

Routine preoperative psychological preparation for patients.

Primary outcomes

  1. The postoperative hospital time

    Time frame: From pre-surgery to discharge, up to 4 weeks

  2. Length of ICU stay

    Time frame: From entering the ICU to roll out, up to 4 weeks

  3. The time of readiness to discharge

    Time frame: From pre-surgery to discharge, up to 4 weeks

  4. The length of hospital stay

    Time frame: From pre-surgery to discharge, up to 8 weeks

  5. Hospitalization cost

    Time frame: When the patient is discharged

Secondary outcomes

  1. Perioperative major adverse events

    Time frame: From pre-surgery to discharge, up to 4 weeks

  2. Vasoactive drugs Support Hours

    Time frame: From the start of drugs to stop them, up to 4 weeks

  3. Postoperative tracheal tube time

    Time frame: From the end of surgery to the removal of tracheal tube, up to 4 weeks

  4. Duration of mechanical ventilation after surgery

    Time frame: From the end of surgery to the recovery of spontaneous breathing, up to 4 weeks

  5. Time to first bowel movement

    Time frame: From the end of surgery to first exhaust, up to 2 weeks

  6. Postoperative time to first exhaust

    Time frame: From the end of surgery to first exhaust, up to 2 weeks

  7. Hemoglobin

    Time frame: baseline and 5 days after operation

    1day before and 1-5days after operation

  8. C-reactive protein

    Time frame: baseline and 5 days after operation

    1day before and 1-5days after operation

  9. Procalcitonin

    Time frame: baseline and 5 days after operation

    1day before and 1-5days after operation

  10. N-terminal B-type natriuretic peptide(NT-proBNP)

    Time frame: baseline and 5 days after operation

    1day before and 1-5days after operation

  11. Serum Creatinine

    Time frame: baseline and 5 days after operation

    1day before and 1-5days after operation

  12. Troponin I

    Time frame: baseline and 5 days after operation

    1day before and 1-5days after operation

  13. Erythrocyte Sedimentation Rate

    Time frame: baseline and 5 days after operation

    1day before and 1-5days after operation

Other outcomes

  1. Questions to the participants' health

    Time frame: Six month

Sponsors and collaborators

Lead sponsor

Xiangya Hospital of Central South University

Other

Registry information

Official study 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

Acronym: ERAS

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Jun 24, 2015
Registry last updated
Jun 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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