Sepsis Related Acute Lung Injury/Acute Respiratory Distress SyndromeNCT01694147
EVLWI Exhibits Pulmonary and Systemic Permeability in Sepsis Related ALI/ARDS
An observational study of Sepsis Related Acute Lung Injury/Acute Respiratory Distress Syndrome, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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). Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Sepsis Related Acute Lung Injury/Acute Respiratory Distress Syndrome
- What is being tested?
- PiCCO monitoring system
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- Jul 2011to Jan 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- sepsis in ICU within 48 hours,
- mechanical ventilator use,
- PaO2/FiO2 < 300,
Who cannot join
- age younger than 20 years,
- known pregnancy,
- participation in another trial within 30 days before meeting the eligibility criteria, and
- terminal malignancy.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chung Gung Memorial Hospital
Linkou, Taiwan, 333
Fu-Tsai Chung, MD, +886-3-3281200 ext. 8468, vikingchung@yahoo.com.tw
Fu-Tsai Chung, MD
About this study
Official title: Extravascular Lung Water Index Exhibits Pulmonary and Systemic Permeability in Patients With Sepsis Related Acute Lung Injury/Acute Respiratory Distress Syndrome.
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).
Read the 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.
- Being tested
- PiCCO monitoring system
- Keywords
- relationship, endothelial injury, vascular permeability, severe sepsis related ALI/ARDS
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PiCCO monitoring systemDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: PiCCO monitoring system |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 days
Secondary outcomes (1)
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.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2012 (estimated)
- Study startJul 2011
- Primary completionDec 2016 (estimated)
- Study completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sepsis Related Acute Lung Injury/Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chung Fu-Tsai, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01694147
- Sponsor's protocol ID
- 99-3957B
- Status last verified
- Sep 2012
- First submitted
- 23 Sep 2012
- Last updated
- 28 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extravascular Lung Water Index Exhibits Pulmonary and Systemic Permeability in Patients With Sepsis Related Acute Lung Injury/Acute Respiratory Distress Syndrome.
- ClinicalTrials.gov ID
- NCT01694147
- Acronym / sponsor ID
- 99-3957B
- Keywords
- relationship, endothelial injury, vascular permeability, severe sepsis related ALI/ARDS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 27 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with sepsis related ALI/ARDS. | – | Device: PiCCO monitoring systemConsecutive septic patients with ALI/ARDS in medical intensive care units (ICUs) will be enrolled. EVLWI will be measured by PiCCO monitoring system. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (3 listed)
- sepsis in ICU within 48 hours,
- mechanical ventilator use,
- PaO2/FiO2 < 300,
Key exclusion criteria (4 listed)
- age younger than 20 years,
- known pregnancy,
- participation in another trial within 30 days before meeting the eligibility criteria, and
- terminal malignancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PiCCO monitoring systemThe 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). | Device | patients with sepsis related ALI/ARDS. |
Primary outcome
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.
1 secondary outcome
relationship between endothelial injury and vascular permeability.
Time frame: 3 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis Related Acute Lung Injury/Acute Respiratory Distress Syndrome, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fu-Tsai Chung, MD (+886-3-3281200 ext. 8468, vikingchung@yahoo.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
vascular permeability of sepsis related ALI/ARDS (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2015.