Neutrophil Phenotypic Profiling and Acute Lung Injury in Patients After Cardiopulmonary Bypass (CPB)
1 other identifier
observational
56
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Oct 2022
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 3, 2020
CompletedFirst Posted
Study publicly available on registry
March 5, 2020
CompletedStudy Start
First participant enrolled
October 14, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
ExpectedAugust 23, 2024
August 1, 2024
3.5 years
March 3, 2020
August 22, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Perform neutrophil analysis in blood and tracheal aspirates samples
We will analyze neutrophil profiles in the blood and tracheal aspirates
2 years
Secondary Outcomes (2)
Determine chemoattractant levels
2 years
Determine neutrophil functions
2 years
Study Arms (2)
Group 1
patients who tend to have longer CPB
Group 2
Patients who have shorter CPB
Interventions
Eligibility Criteria
We will enroll patients \< 12 months of age who undergo CPB surgery. This patient population is associated with the highest incidence of morbidity and mortality following cardiac surgery, due to often prolonged period of CPB. Patients will be categorized into two groups: Group 1: patients who tend to have longer CPB (\> 3 h), (ASO, Stage 1, IAA repair, Truncus repair, TAPVR) and Group 2: Patients who have shorter CPB (\< 3hrs VSD, TOF, ASD).
You may qualify if:
- Are \< 12months of age
- Scheduled for cardiac surgical needing CPB
- Preoperative SpO2 \> 90%
You may not qualify if:
- Lack of parental (or legal guardian's) consent
- Preoperative SpO2 \< 90%
- Preoperative oxygen therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Boston Children's Hospital
Boston, Massachusetts, 02115, United States
Biospecimen
Blood will be collected from existing intravenous or arterial catheters. Tracheal aspirates will be obtained by collecting the suction catheter used.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
March 3, 2020
First Posted
March 5, 2020
Study Start
October 14, 2022
Primary Completion
April 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
August 23, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will not share