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.
1 other identifier
observational
60
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jul 2011
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2011
CompletedFirst Submitted
Initial submission to the registry
September 23, 2012
CompletedFirst Posted
Study publicly available on registry
September 27, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2017
CompletedJuly 28, 2015
September 1, 2012
5.4 years
September 23, 2012
July 27, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
relationship between endothelial injury and vascular permeability.
3 days
Study Arms (1)
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.
Interventions
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).
Eligibility Criteria
Septic patients receiving endotracheal mechanical ventilation for hypoxemic acute respiratory failure were eligible if the following criteria were met for no more than 48 hours before enrollment: ratio of partial pressure of arterial oxygen over fraction of inspired oxygen (PaO2:FIO2) no greater than 300 mm Hg at time of enrollment, recent appearance of bilateral pulmonary infiltrates consistent with edema, and no clinical evidence of left atrial hypertension (pulmonary-capillary wedge pressure \_18 mm Hg, when available).
You may qualify if:
- sepsis in ICU within 48 hours,
- mechanical ventilator use,
- PaO2/FiO2 \< 300,
You may not qualify if:
- age younger than 20 years,
- known pregnancy,
- participation in another trial within 30 days before meeting the eligibility criteria, and
- terminal malignancy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chung Gung Memorial Hospital
Linkou, Taiwan, 333, Taiwan
Biospecimen
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.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Attending physician
Study Record Dates
First Submitted
September 23, 2012
First Posted
September 27, 2012
Study Start
July 1, 2011
Primary Completion
December 1, 2016
Study Completion
January 1, 2017
Last Updated
July 28, 2015
Record last verified: 2012-09