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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-A01246-47 | Other Identifier | ID-RCB |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mechanical ventilation group | Experimental | patients with mechanical ventilation during cardiopulmonary bypass for cardiac surgery |
|
| Control group | Active Comparator | patients without mechanical ventilation during cardiopulmonary bypass for cardiac surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of postoperative infections | During 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Expression of human leukocyte antigen-DR antigen (HLA-DR) | At day 0, day 1 and day 7 | |
| Plasmatic concentration of interleukin 10 (IL10) | At day 0, day 1 and day 7 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Marc TADIE | Rennes Hospital University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Angers | Angers | France | ||||
| CHU Bordeaux |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40323450 | Derived | Tadie JM, Ouattara A, Laviolle B, Lesouhaitier M, Esvan M, Rousseau C, Gregoire M, Gaudriot B, Nesseler N, Labaste F, Sanchez P, Marcheix B, Beurton A, Dureau P, Demondion P, Fouquet O, Rineau E, Amour J, Verhoye JP, Mercat A, Terzi N, Tarte K, Bougle A, Flecher E; VECAR Trial Group and REVA. Maintaining ventilation with very low tidal volume and positive-end expiratory pressure versus no ventilation during cardiopulmonary bypass for cardiac surgery in adults: a randomized clinical trial. Intensive Care Med. 2025 May;51(5):849-860. doi: 10.1007/s00134-025-07901-5. Epub 2025 May 5. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 18, 2017 | Dec 4, 2017 | Prot_SAP_000.pdf |
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| 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 |
|
| Indoleamine 2,3-Dioxygenase (IDO) activity |
| At day 0, day 1 and day 7 |
| Proportion of myeloid-derived suppressor cells (MDSCs) | At day 0, day 1 and day 7 |
| Plasmatic concentration of interleukin 6 (IL-6) | At day 0, day 1 and day 7 |
| Quantity of extracellular vesicles (EV) | At day 0 and day 1 |
| Occurrence of lymphopenia | At day 0, day 1 and day 7 |
| Duration of antibiotic treatment | During 28 days |
| Mortality | During 28 days |
| Length of hospital stay | During 28 days |
| PaO2/FiO2 ratio | At day 0 and day 1 |
| Duration of mechanical ventilation | During 28 days |
| Bordeaux |
| France |
| CHU Lille | Lille | France |
| Hôpital Pitié Salpêtrière | Paris | France |
| CHU Rennes | Rennes | France |
| CHU Toulouse | Toulouse | France |