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

Overview

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).

Full Title of Study: “Extravascular Lung Water Index Exhibits Pulmonary and Systemic Permeability in Patients With Sepsis Related Acute Lung Injury/Acute Respiratory Distress Syndrome.”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 2016

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.

Interventions

  • Device: PiCCO monitoring system
    • The EVLW measurement will be based on transpulmonary thermodilution method. This method was recently introduced as part of the PiCCO plus system (Pulsion Medical System, Munich, Germany), for monitoring severe sepsis patients being treated in medical ICUs. This method only used a single indicator (cold saline solution), and demonstrated a satisfactory correlation with the gravimetric method. A 4-F arterial catheter (PulsiocathPV2014L16; Pulsion Medical Systems, Munich, Germany) was positioned in the descending aorta via the femoral artery using the Seldinger technique. The femoral arterial catheter and a standard central venous catheter were connected to pressure transducers, and also to an integrated bedside monitor (PiCCO; Pulsion Medical Systems).

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • vascular permeability of sepsis related ALI/ARDS
    • Time Frame: 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 Measures

  • relationship between endothelial injury and vascular permeability.
    • Time Frame: 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Chang Gung Memorial Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Chung Fu-Tsai, Attending physician – Chang Gung Memorial Hospital
  • Overall Contact(s)
    • Fu-Tsai Chung, MD, +886-3-3281200, vikingchung@yahoo.com.tw

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