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

Sepsis Related Acute Lung Injury/Acute Respiratory Distress Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01694147
• Other study ID #: 99-3957B
• Status: Recruiting
• Phase: N/A
• First received: September 23, 2012
• Last updated: July 27, 2015
• Start date: July 2011
• Est. completion date: January 2017

Study information

• Verified date: September 2012
• Source: Chang Gung Memorial Hospital
• Contact: Fu-Tsai Chung, MD
• Phone: +886-3-3281200
• Email: vikingchung[@]yahoo.com.tw
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Lung Injury
• Lung Injury
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Sepsis
• Sepsis Related Acute Lung Injury/Acute Respiratory Distress Syndrome
• Toxemia

Intervention

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).

Locations

Country	Name	City	State
Taiwan	Chung Gung Memorial Hospital	Linkou

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	vascular permeability of sepsis related ALI/ARDS	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.	3 days	No
Secondary	relationship between endothelial injury and vascular permeability.	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.	3 days	No