Health TrialsbyHealthPanel

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

ConditionsLung InjuryCardiopulmonary Bypass
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 12
SponsorSophia Koutsogiannaki

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Are < 12months of age

Scheduled for cardiac surgical needing CPB

Preoperative SpO2 > 90%

Disqualifiers

Lack of parental (or legal guardian's) consent

Preoperative SpO2 < 90%

Preoperative oxygen therapy

Trial population

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).

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Research study

    Other intervention

    Blood and tracheal aspirates will be collected

Treatment groups

56 Participants
are divided into 2 treatment groups
Group A: Group 11 intervention
Group B: Group 21 intervention

Trial outcomes

Primary outcomes

1

Perform neutrophil analysis in blood and tracheal aspirates samples

We will analyze neutrophil profiles in the blood and tracheal aspirates

Time frame
2 years

Secondary outcomes

1

Determine chemoattractant levels

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

Time frame
2 years
2

Determine neutrophil functions

We will measure neutrophil functions from the blood and tracheal aspirates

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sophia Koutsogiannaki

Lead sponsor

Boston Children's Hospital

Sponsor institution

Source ClinicalTrials.gov
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