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

NCT ID: NCT01694147

Last Updated: 2015-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-07-31

Study Completion Date

2017-01-31

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Sepsis Related Acute Lung Injury/Acute Respiratory Distress Syndrome

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

PiCCO monitoring system

Intervention Type DEVICE

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).

Interventions

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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).

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Chung Fu-Tsai

Attending physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Chung Gung Memorial Hospital

Linkou, Taiwan, Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Fu-Tsai Chung, MD

Role: CONTACT

+886-3-3281200 ext. 8468

Facility Contacts

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Fu-Tsai Chung, MD

Role: primary

+886-3-3281200 ext. 8468

Other Identifiers

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99-3957B

Identifier Type: -

Identifier Source: org_study_id

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