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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2012 by Chung Fu-Tsai, Chang Gung Memorial Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01694147
First Posted: September 27, 2012
Last Update Posted: July 28, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Chung Fu-Tsai, Chang Gung Memorial Hospital
  Purpose
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).

Condition Intervention
Sepsis Related Acute Lung Injury/Acute Respiratory Distress Syndrome Device: PiCCO monitoring system

Study Type: Observational
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.

Resource links provided by NLM:


Further study details as provided by Chung Fu-Tsai, Chang Gung Memorial Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 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.

Estimated Enrollment: 60
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)
Groups/Cohorts Assigned Interventions
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).

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.

  Eligibility

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
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).
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

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


Contacts
Contact: Fu-Tsai Chung, MD +886-3-3281200 ext 8468 vikingchung@yahoo.com.tw

Locations
Taiwan
Chung Gung Memorial Hospital Recruiting
Linkou, Taiwan, 333
Contact: Fu-Tsai Chung, MD    +886-3-3281200 ext 8468    vikingchung@yahoo.com.tw   
Principal Investigator: Fu-Tsai Chung, MD         
Sponsors and Collaborators
Chang Gung Memorial Hospital
  More Information

Responsible Party: Chung Fu-Tsai, Attending physician, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT01694147     History of Changes
Other Study ID Numbers: 99-3957B
First Submitted: September 23, 2012
First Posted: September 27, 2012
Last Update Posted: July 28, 2015
Last Verified: September 2012

Keywords provided by Chung Fu-Tsai, Chang Gung Memorial Hospital:
relationship
endothelial injury
vascular permeability
severe sepsis related ALI/ARDS

Additional relevant MeSH terms:
Syndrome
Sepsis
Toxemia
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Lung Injury
Disease
Pathologic Processes
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Thoracic Injuries
Wounds and Injuries