EVLWI Exhibits Pulmonary and Systemic Permeability in Sepsis Related ALI/ARDS
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).
Sepsis Related Acute Lung Injury/Acute Respiratory Distress Syndrome
Device: PiCCO monitoring system
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Extravascular Lung Water Index Exhibits Pulmonary and Systemic Permeability in Patients With Sepsis Related Acute Lung Injury/Acute Respiratory Distress Syndrome.|
- vascular permeability of sepsis related ALI/ARDS [ Time Frame: 3 days ] [ Designated as safety issue: No ]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.
- relationship between endothelial injury and vascular permeability. [ Time Frame: 3 days ] [ Designated as safety issue: No ]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.
Biospecimen Retention: Samples Without DNA
To measure the relationship between endothelial injury (serum TM, vWF, VEGF, TIE-2 increase and imbalance of ANG-1/ANG-2) and vascular permeability and EVLWI in patients, 20ml peripheral blood will be sampling retented on day 1 and day 3 after including.
|Study Start Date:||July 2011|
|Estimated Study Completion Date:||January 2017|
|Estimated Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
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.
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).
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01694147
|Contact: Fu-Tsai Chung, MD||+886-3-3281200 ext email@example.com|
|Chung Gung Memorial Hospital||Recruiting|
|Linkou, Taiwan, 333|
|Contact: Fu-Tsai Chung, MD +886-3-3281200 ext 8468 firstname.lastname@example.org|
|Principal Investigator: Fu-Tsai Chung, MD|