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NCT Number: NCT04296071

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

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.

Recruiting

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Key information

Age range

Up to 12 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location status: Recruiting

Location contact

Rachel Bernier

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Research study

Other

Blood and tracheal aspirates will be collected

Primary outcomes

  1. Perform neutrophil analysis in blood and tracheal aspirates samples

    Time frame: 2 years

    We will analyze neutrophil profiles in the blood and tracheal aspirates

Secondary outcomes

  1. Determine chemoattractant levels

    Time frame: 2 years

    We will measure the levels of chemoattractants in the blood and tracheal aspirates

  2. Determine neutrophil functions

    Time frame: 2 years

    We will measure neutrophil functions from the blood and tracheal aspirates

Study contacts

Contact information is provided by the study sponsor or research team.

Koichi Yuki, MD

CONTACT

[email protected]

617-355-6225

Sophia Koutsogiannaki, PhD

CONTACT

[email protected]

617-919-4725

Sponsors and collaborators

Lead sponsor

Sophia Koutsogiannaki

Other

Registry information

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Mar 5, 2020
Registry last updated
May 15, 2026

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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