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Completed

NCT Number: NCT03372174

Maintaining Mechanical Ventilation During Cardiopulmonary Bypass for Cardiac Surgery

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Angers, Angers, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Maintaining mechanical ventilation during surgery

Device

dead space ventilation using tidal volume of 2.5 mL/kg/pbw (predicted body weight) with 5-7 cm H2O Positive end-expiratory pressure

Absence of mechanical ventilation during surgery

Device

absence of mechanical ventilation (and no Positive end-expiratory pressure) by disconnecting the tracheal tube from the ventilator

Primary outcomes

  1. Incidence of postoperative infections

    Time frame: During 28 days

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Registry information

Official study title

Beneficial Effects on Maintaining Mechanical Ventilation During Cardiopulmonary Bypass for Cardiac Surgery on Postoperative Infections

Acronym: VECAR

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Dec 13, 2017
Registry last updated
May 2, 2022

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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