EVLWI Exhibits Pulmonary and Systemic Permeability in Sepsis Related ALI/ARDS

• Conditions: Sepsis Related Acute Lung Injury/Acute Respiratory Distress Syndrome
• Interventions: Device: PiCCO monitoring system

• Registration Number: NCT01694147
• Lead Sponsor: Chang Gung Memorial Hospital

Brief Summary

To investigate the possible mechanisms of pulmonary and systemic permeability change including cytokine, extravascular lung water index (EVLWI), and oxygenation parameters in patients with sepsis related acute lung injury (ALI)/acute respiratory distress syndrome (ARDS).

Detailed Description

This investigation is a prospective control study. Informed consents will be obtained from all patients or their surrogates prior to the procedure of EVLWI measurement and blood sampling for molecular measurement including cytokines.

From July 2011 to June 2014, consecutive septic patients with ARDS in intensive care units (ICUs) will be enrolled at Chang Gung Memorial Hospital, a university-affiliated hospital in Taiwan. EVLWI will be measured by PiCCO monitoring system. Serum cytokine such as endothelin-1, TNF-alfa, IL-6, Tie-1, Tie-2, angiopoietin-1, angiopoietin-2,VEGF and thrombomodulin will be measured.

Study Timeline

• Study Start: 2011-07
• Status Verified: 2012-09
• Study First Submitted: 2012-09-23
• Study First Submitted QC: 2012-09-26
• Study First Posted: 2012-09-27
• Last Update Submitted: 2015-07-27
• Last Update Posted: 2015-07-28
• Primary Completion: 2016-12
• Study Completion: 2017-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• sepsis in ICU within 48 hours,
• mechanical ventilator use,
• PaO2/FiO2 < 300,

Exclusion Criteria

• age younger than 20 years,
• known pregnancy,
• participation in another trial within 30 days before meeting the eligibility criteria, and
• terminal malignancy.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients with sepsis related ALI/ARDS.	PiCCO monitoring system	Consecutive septic patients with ALI/ARDS in medical intensive care units (ICUs) will be enrolled. EVLWI will be measured by PiCCO monitoring system.

Primary Outcome Measures

Name	Time	Method
vascular permeability of sepsis related ALI/ARDS	3 days	vascular permeability (day 1 and 3 EVLWI, lung permeability, 24hr fluid balance, microalbuminuria, DAMPs/RAGE, Ang-1, 2 and TIE-2 level, will be detected in the blood sampling) and sepsis-induced ALI/ARDS.

Secondary Outcome Measures

Name	Time	Method
relationship between endothelial injury and vascular permeability.	3 days	relationship between endothelial injury (serum TM, vWF, VEGF, TIE-2 increase and imbalance of ANG-1/ANG-2) and vascular permeability in patients with sepsis related ALI/ARDS.

Trial Locations

Locations (1)

Chung Gung Memorial Hospital; 🇨🇳 Linkou, Taiwan