EVLWI Exhibits Pulmonary and Systemic Permeability in Sepsis Related ALI/ARDS
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|ClinicalTrials.gov Identifier: NCT01694147|
Recruitment Status : Unknown
Verified September 2012 by Chung Fu-Tsai, Chang Gung Memorial Hospital.
Recruitment status was: Recruiting
First Posted : September 27, 2012
Last Update Posted : July 28, 2015
|Condition or disease||Intervention/treatment|
|Sepsis Related Acute Lung Injury/Acute Respiratory Distress Syndrome||Device: PiCCO monitoring system|
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 Type :||Observational|
|Estimated Enrollment :||60 participants|
|Official Title:||Extravascular Lung Water Index Exhibits Pulmonary and Systemic Permeability in Patients With Sepsis Related Acute Lung Injury/Acute Respiratory Distress Syndrome.|
|Study Start Date :||July 2011|
|Estimated Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||January 2017|
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).
- 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.
- 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.
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01694147
|Contact: Fu-Tsai Chung, MD||+886-3-3281200 ext firstname.lastname@example.org|
|Chung Gung Memorial Hospital||Recruiting|
|Linkou, Taiwan, 333|
|Contact: Fu-Tsai Chung, MD +886-3-3281200 ext 8468 email@example.com|
|Principal Investigator: Fu-Tsai Chung, MD|