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

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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

Tracking Information
First Submitted Date  ICMJE December 4, 2017
First Posted Date  ICMJE December 13, 2017
Last Update Posted Date June 9, 2020
Actual Study Start Date  ICMJE January 10, 2018
Estimated Primary Completion Date February 10, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 7, 2017)
Incidence of postoperative infections [ Time Frame: During 28 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 7, 2017)
  • Expression of human leukocyte antigen-DR antigen (HLA-DR) [ Time Frame: At day 0, day 1 and day 7 ]
  • Plasmatic concentration of interleukin 10 (IL10) [ Time Frame: At day 0, day 1 and day 7 ]
  • Indoleamine 2,3-Dioxygenase (IDO) activity [ Time Frame: At day 0, day 1 and day 7 ]
  • Proportion of myeloid-derived suppressor cells (MDSCs) [ Time Frame: At day 0, day 1 and day 7 ]
  • Plasmatic concentration of interleukin 6 (IL-6) [ Time Frame: At day 0, day 1 and day 7 ]
  • Quantity of extracellular vesicles (EV) [ Time Frame: At day 0 and day 1 ]
  • Occurrence of lymphopenia [ Time Frame: At day 0, day 1 and day 7 ]
  • Duration of antibiotic treatment [ Time Frame: During 28 days ]
  • Mortality [ Time Frame: During 28 days ]
  • Length of hospital stay [ Time Frame: During 28 days ]
  • PaO2/FiO2 ratio [ Time Frame: At day 0 and day 1 ]
  • Duration of mechanical ventilation [ Time Frame: During 28 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Maintaining Mechanical Ventilation During Cardiopulmonary Bypass for Cardiac Surgery
Official Title  ICMJE Beneficial Effects on Maintaining Mechanical Ventilation During Cardiopulmonary Bypass for Cardiac Surgery on Postoperative Infections
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE Cardiopulmonary Bypass
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: Mechanical ventilation group
    patients with mechanical ventilation during cardiopulmonary bypass for cardiac surgery
    Intervention: Device: Maintaining mechanical ventilation during surgery
  • Active Comparator: Control group
    patients without mechanical ventilation during cardiopulmonary bypass for cardiac surgery
    Intervention: Device: Absence of mechanical ventilation during surgery
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 7, 2017)
1400
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 10, 2022
Estimated Primary Completion Date February 10, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03372174
Other Study ID Numbers  ICMJE 35RC16_9908_VECAR
2017-A01246-47 ( Other Identifier: ID-RCB )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Rennes University Hospital
Study Sponsor  ICMJE Rennes University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jean-Marc TADIE Rennes Hospital University
PRS Account Rennes University Hospital
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP