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

Sponsor
Sophia Koutsogiannaki (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04296071
Collaborator
(none)
56
1
24
2.3

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Research study

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
56 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Neutrophil Phenotypic Profiling and Acute Lung Injury in Patients After Cardiopulmonary Bypass (CPB)
Anticipated Study Start Date :
Dec 1, 2022
Anticipated Primary Completion Date :
Apr 1, 2024
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Group 1

patients who tend to have longer CPB

Other: Research study
Blood and tracheal aspirates will be collected

Group 2

Patients who have shorter CPB

Other: Research study
Blood and tracheal aspirates will be collected

Outcome Measures

Primary Outcome Measures

  1. Perform neutrophil analysis in blood and tracheal aspirates samples [2 years]

    We will analyze neutrophil profiles in the blood and tracheal aspirates

Secondary Outcome Measures

  1. Determine chemoattractant levels [2 years]

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

  2. Determine neutrophil functions [2 years]

    We will measure neutrophil functions from the blood and tracheal aspirates

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 12 Months
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Boston Children's Hospital Boston Massachusetts United States 02115

Sponsors and Collaborators

  • Sophia Koutsogiannaki

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sophia Koutsogiannaki, Assistant Professor, Boston Children's Hospital
ClinicalTrials.gov Identifier:
NCT04296071
Other Study ID Numbers:
  • IRB-P00034280
First Posted:
Mar 5, 2020
Last Update Posted:
Aug 9, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 9, 2022