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

Extravascular Lung Water Index Exhibits Pulmonary and Systemic Permeability in Patients With Sepsis Related Acute Lung Injury/Acute Respiratory Distress Syndrome.

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01694147
Enrollment
60
Registered
2012-09-27
Start date
2011-07-31
Completion date
2017-01-31
Last updated
2015-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sepsis Related Acute Lung Injury/Acute Respiratory Distress Syndrome

Keywords

relationship, endothelial injury, vascular permeability, severe sepsis related ALI/ARDS

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.

Interventions

DEVICEPiCCO 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).

Sponsors

Chang Gung Memorial Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
vascular permeability of sepsis related ALI/ARDS3 daysvascular 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

MeasureTime frameDescription
relationship between endothelial injury and vascular permeability.3 daysrelationship 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.

Countries

Taiwan

Contacts

Primary ContactFu-Tsai Chung, MD
vikingchung@yahoo.com.tw+886-3-3281200

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026