NCT02693912

Brief Summary

In this study, the investigators aim to observe the change in alveolar macrophage function during acute lung injury.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2016

Status
unknown

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

February 11, 2016

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 29, 2016

Completed
6 months until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

February 29, 2016

Status Verified

February 1, 2016

Enrollment Period

1.2 years

First QC Date

February 11, 2016

Last Update Submit

February 26, 2016

Conditions

Keywords

efferocytosismacrophage

Outcome Measures

Primary Outcomes (1)

  • alveolar macrophages (AMs) phagocytic index

    AMs will be collected and cultured in vitro. Apoptotic neutrophils will then be cocultured with AMs for 1 hour. To measure phagocytosis of apoptotic neutrophils, AMs were further processed and phagocytosed apoptotic neutrophils were detected by confocal fluorescence microscopy as described below under Cell staining and confocal microscopy. The phagocytic index was calculated according to the following formula: phagocytic index = (total number of engulfed cells/total number of counted macrophages) × (number of macrophages containing engulfed cells/total number of counted macrophages) × 100.

    7 days after admission

Secondary Outcomes (1)

  • 30 days mortality

    30 days after admission

Study Arms (2)

acute lung injury

Patients with a diagnosis of acute lung injury (ALI) under mechanical ventilation.Patients will underwent bronchoscopy for bronchoalveolar lavage fluid.

Procedure: Bronchoscopy

control

Patient under mechanical ventilation without any lung diseases. Patients will underwent bronchoscopy for bronchoalveolar lavage fluid.

Procedure: Bronchoscopy

Interventions

BronchoscopyPROCEDURE

Bronchoscopy will be implemented under sedation in both groups.

acute lung injurycontrol

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

ALI and acute respiratory distress syndrome (ARDS) are characterized by an increased permeability of the alveolar-capillary barrier resulting in lung edema with protein-rich fluid, thus resulting in impairment of arterial oxygenation. ALI/ARDS is defined as a lung disease with acute onset, noncardiac, diffuse bilateral pulmonary infiltrates and a paO2/FiO2 ≤ 300 for ALI or a paO2/FiO2 ≤ 200 for ARDS. The ageadjusted incidence of ALI/ARDS is estimated with 86.2 per 100,000 person-years. Despite all innovations in intensive care medicine, the mortality of ARDS remains up to 40%.

You may qualify if:

  • Patients in ICU with diagnosed ALI under mechanical ventilation

You may not qualify if:

  • Patients with cardiac dysfunction, using steroid drugs or other drugs can that affect efferocytosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

bronchoalveolar lavage fluid will be collected which contains immune cells, including macrophages.

MeSH Terms

Conditions

Acute Lung Injury

Interventions

Bronchoscopy

Condition Hierarchy (Ancestors)

Lung InjuryLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalMinimally Invasive Surgical ProceduresSurgical Procedures, OperativePulmonary Surgical ProceduresThoracic Surgical Procedures

Study Officials

  • Jin Liu

    West China Hospital

    STUDY CHAIR

Central Study Contacts

Chunling Jiang

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

February 11, 2016

First Posted

February 29, 2016

Study Start

September 1, 2016

Primary Completion

December 1, 2017

Study Completion

August 1, 2018

Last Updated

February 29, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will not share

no plan has been made to share data