Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

On-pump Beating Coronary Artery Bypass Grafting by Ventricular Assist

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02731794
Recruitment Status : Recruiting
First Posted : April 8, 2016
Last Update Posted : December 3, 2018
Sponsor:
Information provided by (Responsible Party):
Jian Zhao, Henan Institute of Cardiovascular Epidemiology

Brief Summary:
The investigators designed the randomized prospective study to evaluate the differences of inflammatory response and clinical outcome after on-pump beating coronary artery bypass grafting undergoing left ventricular assist versus biventricular assist in patients with severe left ventricle dysfunction.

Condition or disease Intervention/treatment Phase
Coronary Artery Bypass Device: left ventricular assist Procedure: Biventricular assist Phase 4

Detailed Description:

Off-pump coronary artery bypass grafting (CABG) tends to have a lower incidence of postoperative complications and remarkable advantages in terms of hospital stay. However, some drawbacks include higher rates of incomplete revascularization and the hemodynamic deterioration during manipulation of the heart, more occurring in the cases of posterolateral anatomical constraints and cardiac dysfunction. It leads to urgent conversion to extracorporeal circulation (ECC) and increases the mortality. Although conventional ECC with cardioplegia arrest provides bloodless immovable field, intense systemic inflammatory response may contribute to hemodynamic unstability especially in patients already with severe cardiac dysfunction.

On-pump beating CABG, as a more comprehensive approach, not only facilitates stable hemodynamics and complete revascularization, but also supports myocardial lymphatic flow balance and decreases interstitial myocardial edema in the beating state. Especially in the high-risk patients,some findings suggested that off-pump CABG should be converted to on-pump beating CABG without hesitation, avoiding hemodynamic collapse and even catastrophic outcomes. Some investigators intentionally planned on-pump beating CABG aiming to some patients with severe left ventricle dysfunction. Furthermore, on-pump beating CABG with ECC assistance in a high-risk subgroup is also an acceptable trade-off between conventional cardioplegia and off-pump operations.

The above-mentioned ECC results about on-pump, beating-heart CABG pay much attention to the biventricular assist (BiVA). Nonetheless, much evidence also reveals that BiVA triggers an intense inflammatory response due to extracorporeal membrane lung and circuit line. Comparatively speaking, single left ventricular assist (LVA), with shorter circuit line, less priming volume and free of extracorporeal membrane lung, theoretically should reduce the inflammatory response and relative complications. As a result, aiming to the high-risk patients with severe left ventricle dysfunction, who need ECC assistance (BiVA or LVA), the investigators designed the randomized prospective study to evaluate: 1) the differences in myocardial injury as expressed by cardiac Troponin I(cTnI) and in inflammatory response by C-reactive protein (CRP), 2) the differences in the early postoperative outcomes including graft number, incidence of atrial fibrillation, in-hospital mortality and ICU stay.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Inflammatory Response and Clinical Outcome After On-pump Beating Coronary Artery Bypass Grafting Using Left Ventricular Assist Versus Biventricular Assist in Patients With Severe Left Ventricle Dysfunction
Study Start Date : May 2016
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: LVA group
LVA group: left ventricular assist group.
Device: left ventricular assist
In left ventricular assist group, 100 IU/kg heparin was given to activated clotting time (ACT) greater than 180 seconds. A 22 French arterial cannula (Maquet, Irrlingen, Germany) was introduced into the ascending aorta, and a 26 French cannula (Eurosets, Medolla, Italy) into the left atrium and advanced into the left ventricle. The two cannulas are directly connected through a short, heparin-coated circuit to a centrifuge pump (Maquet, Getinge Group, Germany). A flow of 1.0 to 4.0 L/min/m2 is obtained and mean blood pressure was maintained 55-75 mm Hg. Note: Both LVA group and BiVA group have the operative protocols itself,includes different prime fluid and cannula pathway. The investigators think it is inapplicable to assign the different operative protocols to the Treatment Arm.

Active Comparator: BiVA group
BiVA group: Biventricular assist group.
Procedure: Biventricular assist
In biventricular assist group, the patients were routinely heparinized with a dose of 300 IU/kg heparin to ACT greater than 480 seconds. Cardiopulmonary bypass with a centrifuge pump (Maquet, Getinge Group, Germany) was established by 22 French aortic cannulation and 34 French two-stage venous cannula through the right atrial appendage. The extracorporeal circuit was primed with 2000 mL of lactated Ringer's solution, albumin, 25% mannitol and 5% NaHCO3. The flow was 1.0 to 4.0 L/min/m2 and mean blood pressure was maintained 55-75 mm Hg.




Primary Outcome Measures :
  1. Changes of C-reactive protein (CRP) [ Time Frame: up tp 72 hours ]
    Serial blood samples for inflammatory response of CRP were collected at the following time points: 1: induction of anesthesia, 2: upon termination of cardiopulmonary bypass (CPB), 3: 6 hours postoperatively, 4: 24 hours postoperatively, 5: 48 hours postoperatively, 6: 72 hours postoperatively.


Secondary Outcome Measures :
  1. Incidence of atrial fibrillation [ Time Frame: 10 days ]
    from ICU admission to discharge

  2. Durations of mechanical ventilation [ Time Frame: 10 days ]
  3. The number for transfused packed red cells [ Time Frame: up to 10 days ]
    measured by milliliter from ICU admission to discharge

  4. Partial oxygen pressure/inspired oxygen fraction (P/F) [ Time Frame: up tp 10 days ]
  5. Cardiac Troponin I (cTnI) [ Time Frame: up to72 hours ]
    Serial blood samples for cTnI were collected at the following time points: 1: induction of anesthesia, 2: upon termination of CPB, 3: 6 hours postoperatively, 4: 24 hours postoperatively, 5: 48 hours postoperatively, 6: 72 hours postoperatively.

  6. In-hospital mortality [ Time Frame: up to 10 days ]
    from ICU admission to discharge



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with severe left ventricle dysfunction with an ejection fraction (EF)≤40%, being scheduled for revascularization.

Exclusion Criteria:

  • myocardial infarction within the preceding 4 weeks
  • severe valve disease requiring valve replacement
  • cardiac reoperations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02731794


Contacts
Layout table for location contacts
Contact: You Zhang, MD 13598019682 ext 037165580759 13598019682@126.com
Contact: Zhaoyun Cheng, MD 13903712068 ext 037165580860 13598019682@126.com

Locations
Layout table for location information
China, Henan
Henan Provincial People' Hospital Recruiting
Zhengzhou, Henan, China, 450003
Contact: You Zhang, MD    13598019682 ext 037165580759    13598019682@126.com   
Sponsors and Collaborators
Henan Institute of Cardiovascular Epidemiology
Investigators
Layout table for investigator information
Study Director: Zhaoyun Cheng, MD Henan Provincial People' Hospital

Publications of Results:

Layout table for additonal information
Responsible Party: Jian Zhao, associate professor, Henan Institute of Cardiovascular Epidemiology
ClinicalTrials.gov Identifier: NCT02731794     History of Changes
Other Study ID Numbers: HenanICE201602
First Posted: April 8, 2016    Key Record Dates
Last Update Posted: December 3, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Jian Zhao, Henan Institute of Cardiovascular Epidemiology:
cardiopulmonary bypass
coronary artery bypass grafting
inflammatory response
cardiac dysfunction