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Recruiting NCT04296071

Neutrophil Phenotypic Profiling and Acute Lung Injury in Patients After Cardiopulmonary Bypass (CPB)

Observational Lung Injury Cardiopulmonary Bypass

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Research study.
Who it may be relevant to
Registry conditions: Lung Injury, Cardiopulmonary Bypass. Basic parameters: up to 12 months · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

Acute lung injury (ALI) following cardiopulmonary bypass (CPB) is a serious complication, often prolonging the length of stay in ICU and potentially dealing to mortality. The objective of this study is to assess the mechanism of CPB-mediated acute lung injury in pediatric patients.

Detailed description

Acute lung injury (ALI) is frequently associated with the use of extracorporeal circulation during cardiopulmonary bypass (CPB) surgery and develops postoperatively in 2-3% of cardiac surgical patients. Histological evidence shows that CPB increases pulmonary vascular permeability and extravascular lung water content while diminishing pulmonary compliance. Furthermore, some patients can develop acute respiratory distress syndrome, which has a mortality rate of 50-70%. Recruitment of intrapulmonary neutrophils is a characteristic of ALI following CPB. Blood contact with non-physiological surfaces, cooling and rewarming and mechanical shear stress activate neutrophils. The recruitment of activated neutrophils from blood vessels to local tissue involves a chain of well-coordinated events, including adhesion, tethering, rolling and crawling, followed by trans-endothelial and trans-epithelial migration. Activation of sequestered neutrophils causes the release of specific proteolytic enzymes and oxygen free radicals, which leads to increased alveolar-endothelial permeability and parenchymal damage. During CPB, the lungs are almost completely excluded from the systemic circulation, which causes the blood within them to be almost 'static'. Pulmonary tissue hypoxia and re-oxygenation combined with vascular ischemia and reperfusion induce the generation of chemokines, which contributes to subsequent injury by accumulating and entrapping activated neutrophils. The accumuled and entrapped activated neutrophils in the lungs and the subsequent release of toxic substances render the lungs highly susceptible to this damage. However, the mechanism that drives neutrophil migration to the lungs after CPB is not well studied. This study will delineate the mechanisms of neutrophil migration to the lung and subsequent lung injury after CPB.

Interventions

  • Other Research study
    Blood and tracheal aspirates will be collected

Primary outcome measures

  • Perform neutrophil analysis in blood and tracheal aspirates samples [Time frame: 2 years]
Secondary outcome measures (2)
  • Determine chemoattractant levels [Time frame: 2 years]
  • Determine neutrophil functions [Time frame: 2 years]

Eligibility criteria

Inclusion criteria

  • Are < 12months of age
  • Scheduled for cardiac surgical needing CPB
  • Preoperative SpO2 > 90%

Exclusion criteria

  • Lack of parental (or legal guardian's) consent
  • Preoperative SpO2 < 90%
  • Preoperative oxygen therapy

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Boston Children's Hospital — Boston

Identifiers

NCT: NCT04296071 · IRB-P00034280

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗