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Maintaining Mechanical Ventilation During Cardiopulmonary Bypass for Cardiac Surgery (VECAR)

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: NCT03372174
Recruitment Status : Recruiting
First Posted : December 13, 2017
Last Update Posted : June 9, 2020
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital

Brief Summary:
The main objective of this study is to measure the incidence of postoperative infections in 2 groups of patients: one group of patients ventilated and one group of patients without mechanical ventilation during cardiopulmonary bypass for cardiac surgery, and demonstrate that the incidence of postoperative infections is significantly lower in patients ventilated during cardiopulmonary bypass.

Condition or disease Intervention/treatment Phase
Cardiopulmonary Bypass Device: Maintaining mechanical ventilation during surgery Device: Absence of mechanical ventilation during surgery Not Applicable

Detailed Description:
Cardiopulmonary bypass (CBP) during cardiac surgery induces a systemic inflammatory response associated with an immune dysregulation and a significant pulmonary dysfunction. First, the inflammatory response, usually attributed to surgical trauma, contact of blood with artificial surfaces, and ischemia reperfusion injury, is responsible for a postoperative immunodepression. For instance, an early impairment of lung cellular immune response after CPB, which could promote the development of postoperative pneumonia, has been found. Along these lines, a downregulation of human leukocyte antigen-DR antigen (HLA-DR) expression on monocytes and an increase in plasma interleukin 10 (IL-10) associated with the occurrence of nosocomial infections have been reported. Second, CPB induces a pulmonary dysfunction, which ranges from a temporary and clinically insignificant reduction in arterial oxygenation to a life-threatening injury manifested as acute respiratory distress syndrome (ARDS). This phenomenon is of multifactorial sources, but one of the main mechanisms is the occurrence of atelectasis during surgery. Atelectasis has been associated with lung injury and release of cytokines by shear forces on alveoli and small airways. However, it is not clear whether this injury is due to a recruitment/derecruitment phenomenon (i.e., atelectrauma) or whether it might by itself lead to the release of cytokine. Since CPB mechanically circulates and oxygenates blood bypassing the heart and lungs, usual procedure during CPB is to stop mechanical ventilation (MV) (apnea). Nevertheless, maintaining MV with positive expiratory pressure (PEEP) during CPB diminished the occurrence of atelectasis and the postoperative inflammatory response. Thus, we investigated the effects of maintaining MV during CPB for cardiac surgery on postoperative immunodepression and found that maintaining MV during CPB decreased postoperative immune dysfunction and could be an interesting strategy to diminish the occurrence of postoperative infection (nosocomial infection) without hampering the surgical procedure. However, these findings have to be confirmed in a clinical trial using the incidence of nosocomial infection as an endpoint.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Beneficial Effects on Maintaining Mechanical Ventilation During Cardiopulmonary Bypass for Cardiac Surgery on Postoperative Infections
Actual Study Start Date : January 10, 2018
Estimated Primary Completion Date : February 10, 2021
Estimated Study Completion Date : February 10, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Arm Intervention/treatment
Experimental: Mechanical ventilation group
patients with mechanical ventilation during cardiopulmonary bypass for cardiac surgery
Device: Maintaining mechanical ventilation during surgery
dead space ventilation using tidal volume of 2.5 mL/kg/pbw (predicted body weight) with 5-7 cm H2O Positive end-expiratory pressure

Active Comparator: Control group
patients without mechanical ventilation during cardiopulmonary bypass for cardiac surgery
Device: Absence of mechanical ventilation during surgery
absence of mechanical ventilation (and no Positive end-expiratory pressure) by disconnecting the tracheal tube from the ventilator




Primary Outcome Measures :
  1. Incidence of postoperative infections [ Time Frame: During 28 days ]

Secondary Outcome Measures :
  1. Expression of human leukocyte antigen-DR antigen (HLA-DR) [ Time Frame: At day 0, day 1 and day 7 ]
  2. Plasmatic concentration of interleukin 10 (IL10) [ Time Frame: At day 0, day 1 and day 7 ]
  3. Indoleamine 2,3-Dioxygenase (IDO) activity [ Time Frame: At day 0, day 1 and day 7 ]
  4. Proportion of myeloid-derived suppressor cells (MDSCs) [ Time Frame: At day 0, day 1 and day 7 ]
  5. Plasmatic concentration of interleukin 6 (IL-6) [ Time Frame: At day 0, day 1 and day 7 ]
  6. Quantity of extracellular vesicles (EV) [ Time Frame: At day 0 and day 1 ]
  7. Occurrence of lymphopenia [ Time Frame: At day 0, day 1 and day 7 ]
  8. Duration of antibiotic treatment [ Time Frame: During 28 days ]
  9. Mortality [ Time Frame: During 28 days ]
  10. Length of hospital stay [ Time Frame: During 28 days ]
  11. PaO2/FiO2 ratio [ Time Frame: At day 0 and day 1 ]
  12. Duration of mechanical ventilation [ Time Frame: During 28 days ]


Information from the National Library of Medicine

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

Inclusion Criteria:

  • Age ≥ 18 years old;
  • Scheduled for any cardiac surgery (elective surgery) with cardio-pulmonary bypass, aortic clamp and cardioplegia, with median sternotomy and bi-pulmonary ventilation (cardiac valvular surgery (valve replacement or repair), coronary artery surgery, ascending aortic surgery and/or combined);
  • Written informed consent.

Exclusion Criteria:

  • Emergency surgery ;
  • Planned thoracotomy with one lung ventilation ;
  • Patients with known respiratory diseases (current respiratory infections, asthma, chronic obstructive or restrictive pulmonary disease, obstructive apnea syndrome) ;
  • Patients already intubated in the peri-operative period ;
  • Immunodepression defined by proven humoral or cellular deficiency, by continuous administration of steroids at any dose for more than one month prior to hospitalization, high-dose steroids (> 15 mg / kg / day of methylprednisolone or Equivalent), radiotherapy or chemotherapy in the previous year;;
  • Need for vasopressor or inotropic agents before surgery ;
  • Any acute infection in the last month before surgery ;
  • Hematological disorder, autoimmune disease, immunodeficiency, immunosuppressive therapy ;
  • Heart failure with an left ventricular ejection fraction<35% ;
  • Protected person (adults legally protected (under judicial protection, guardianship, or supervision), person deprived of their liberty.

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): NCT03372174


Contacts
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Contact: Jean-Marc TADIE 02.99.28.42.48 jean-marc.tadie@chu-rennes.fr
Contact: Anne GANIVET 02.99.28.25.55 anne.ganivet@chu-rennes.fr

Locations
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France
CHU Angers Recruiting
Angers, France
Contact: Olivier Fouquet         
Sub-Investigator: Christophe Baufreton         
Sub-Investigator: Carole Fleury         
Principal Investigator: Olivier Fouquet         
CHU Bordeaux Recruiting
Bordeaux, France
Contact: Alexandre Ouatarra         
Sub-Investigator: Laurent Barandon         
Principal Investigator: Alexandre Ouatarra         
CHU Lille Not yet recruiting
Lille, France
Contact: André Vincentelli         
Principal Investigator: André Vincentelli         
Sub-Investigator: Emmanuel Robin         
Hôpital Pitié Salpêtrière Recruiting
Paris, France
Contact: Pascal Leprince         
Sub-Investigator: Pascal Leprince         
Principal Investigator: Julien Amour         
CHU Rennes Recruiting
Rennes, France
Contact: Jean-Marc TADIE         
Principal Investigator: Jean-Marc TADIE         
Sub-Investigator: Erwan FLECHER         
CHU Toulouse Recruiting
Toulouse, France
Contact: Pascale Sanchez Verlaan         
Sub-Investigator: Bertrand Marcheix         
Principal Investigator: Pascale Sanchez Verlaan         
Sponsors and Collaborators
Rennes University Hospital
Investigators
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Principal Investigator: Jean-Marc TADIE Rennes Hospital University
  Study Documents (Full-Text)

Documents provided by Rennes University Hospital:
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Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT03372174    
Other Study ID Numbers: 35RC16_9908_VECAR
2017-A01246-47 ( Other Identifier: ID-RCB )
First Posted: December 13, 2017    Key Record Dates
Last Update Posted: June 9, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rennes University Hospital:
cardiac surgery
mechanical ventilation
postoperative infections