Acute Respiratory Distress SyndromeNCT01301872
Effect of Mechanical Ventilation Strategy on Lung Injury in Patients With Less Severe Acute Respiratory Distress Syndrome: Targeted on RAGE
A study testing check biomarker :RAGE in people with Acute Respiratory Distress Syndrome, run by National Taiwan University Hospital.
Trial summary
During the past two decades, there current concept has evolved significantly that ventilator-induced lung injury (VILI) may not only impose a direct mechanical stress and subsequent injury to the lungs, but may also induce local as well as systemic inflammation responses, generally referred as biotrauma.1 Patients… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome
- What is being tested?
- check biomarker :RAGE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Dec 2012to Dec 2013
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All intubated and mechanically ventilated patients who meet the criteria of American-European Consensus Conference (AECC) criteria for ALI/ ARDS:
- Acute onset of illness Bilateral (patchy, diffuse, or homogeneous) infiltrates consistent with pulmonary edema PaO2/FiO2 <= 300 (corrected for altitude): (P/F <300 for ALI and P/F <200 for ARDS) No clinical evidence of left atrial hypertension
Who cannot join
- 1. Age <18 years 2. Enrolled in other clinical trials 3. Had confirmed alternative diagnoses that would have different clinical course than ARDS/ALI, e.g., diffuse alveolar hemorrhage, vasculitis, interstitial pneumonitis, etc.
- 4. Congestive heart failure related pulmonary edema 5. Acute myocardial infarction 6. Pregnancy 7. Patients with definite contraindication to the use of low-tidal volume ventilation, e.g., increased intracranial pressure, tricyclic antidepressant overdose, etc.
- 8. The patient who meets inclusion criteria initially but rapidly improved within 24 hours of diagnosis of ARDS/ALI
Trial locations and contacts
No sites are listed yet.
About this study
During the past two decades, there current concept has evolved significantly that ventilator-induced lung injury (VILI) may not only impose a direct mechanical stress and subsequent injury to the lungs, but may also induce local as well as systemic inflammation responses, generally referred as biotrauma.1 Patients with ARDS often die of severe systemic inflammatory response syndrome (SIRS) and multiorgan dysfunction2 rather than refractory hypoxemia. Ranieri et al found that patients with less severe ARDS, i.e., a lung injury score of 2.5 or less, receiving ventilation with lung protective strategy involving low tidal volume (7.5 mL/kg PBW) and high PEEP could attenuate the pulmonary and systemic cytokine response compared with conventional ventilation with high tidal volume.3 Stuber et al found an increase in pro-inflammatory cytokines in the lung and plasma of patients with ARDS within 1 hour after switching the patients from a protective to non-protective ventilator strategy.4 The receptor for advanced glycation end-products (RAGE) was recently identified as a marker of injury to the alveolar type I epithelial cells5. Clinical studies showed that the plasma level of RAGE was associated with severity of lung injury and clinical outcome, and low tidal volume strategy ventilation accelerated the decline in plasma RAGE levels. These results suggest plasma RAGE level might be a reliable biomarker of alveolar epithelial injury in acute lung injury and may associated with ventilator induced lung injury6. Although, current approach to mechanical ventilation of a patient with ARDS emphasizes the use of lower tidal volumes with lower plateau pressures to avoid causing lung overdistension and ventilator associated lung injury (VILI)7; however, in the real world, some studies showed that strictly reduction of tidal volume to 6ml/kg PBW was modest in modern time, and was noticed only in patients with greater lung injury scores8. The benefit of VT strictly reduction to 6ml/kgPBW and its effect on VILI in patients with less severe ARDS whose Pplat are already below 30 cmH2O are controversy9. One of the possible solutions is to look at the biomarkers of injury to alveolar epithelial cells. Of these potentially promising markers, the receptor for advanced glycation end-product (RAGE) is of great interest.
We hypothesize that a strategy with strict low tidal volume in less severe ARDS and ALI patients with good compliance may be beneficial to this patient population. Therefore, we wish to propose a prospective single-center study to investigate the effect of mechanical ventilation strategy on the plasma level of RAGE in patients with less severe ARDS and acute lung injury.
Read the detailed description
During the past two decades, there current concept has evolved significantly that ventilator-induced lung injury (VILI) may not only impose a direct mechanical stress and subsequent injury to the lungs, but may also induce local as well as systemic inflammation responses, generally referred as biotrauma.1 Patients with ARDS often die of severe systemic inflammatory response syndrome (SIRS) and multiorgan dysfunction2 rather than refractory hypoxemia. Ranieri et al found that patients with less severe ARDS, i.e., a lung injury score of 2.5 or less, receiving ventilation with lung protective strategy involving low tidal volume (7.5 mL/kg PBW) and high PEEP could attenuate the pulmonary and systemic cytokine response compared with conventional ventilation with high tidal volume.3 Stuber et al found an increase in pro-inflammatory cytokines in the lung and plasma of patients with ARDS within 1 hour after switching the patients from a protective to non-protective ventilator strategy.4 The receptor for advanced glycation end-products (RAGE) was recently identified as a marker of injury to the alveolar type I epithelial cells5. Clinical studies showed that the plasma level of RAGE was associated with severity of lung injury and clinical outcome, and low tidal volume strategy ventilation accelerated the decline in plasma RAGE levels. These results suggest plasma RAGE level might be a reliable biomarker of alveolar epithelial injury in acute lung injury and may associated with ventilator induced lung injury6. Although, current approach to mechanical ventilation of a patient with ARDS emphasizes the use of lower tidal volumes with lower plateau pressures to avoid causing lung overdistension and ventilator associated lung injury (VILI)7; however, in the real world, some studies showed that strictly reduction of tidal volume to 6ml/kg PBW was modest in modern time, and was noticed only in patients with greater lung injury scores8. The benefit of VT strictly reduction to 6ml/kgPBW and its effect on VILI in patients with less severe ARDS whose Pplat are already below 30 cmH2O are controversy9. One of the possible solutions is to look at the biomarkers of injury to alveolar epithelial cells. Of these potentially promising markers, the receptor for advanced glycation end-product (RAGE) is of great interest.
We hypothesize that a strategy with strict low tidal volume in less severe ARDS and ALI patients with good compliance may be beneficial to this patient population. Therefore, we will to propose a prospective single-center study to investigate the effect of mechanical ventilation strategy on the plasma level of RAGE in patients with less severe ARDS and acute lung injury.
- Conditions
- Acute Respiratory Distress Syndrome
- Being tested
- check biomarker :RAGE
- 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.
check biomarker :RAGEOther
We will check RAGE for all patients who have ARDS included in our study
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | All patients meet ALI/less severe ARDS criteria Receives: Other: check biomarker :RAGE |
What is being measured
The primary outcome is the main question the study is designed to answer.
the effect of mechanical ventilation strategy on the plasma level of RAGE in patients with less severe ARDS and acute lung injury.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2011 (estimated)
- Study startDec 2012
- Primary completionDec 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- More trials run by National Taiwan University 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jih-Shuin Jerng, MD,PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01301872
- Sponsor's protocol ID
- 201012005RB
- Status last verified
- Nov 2012
- First submitted
- 18 Feb 2011
- Last updated
- 27 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Mechanical Ventilation Strategy on Lung Injury in Patients With Less Severe Acute Respiratory Distress Syndrome: Targeted on RAGE
- ClinicalTrials.gov ID
- NCT01301872
- Acronym / sponsor ID
- 201012005RB
- Conditions
- Acute Respiratory Distress Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 23 Feb 2011 (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.
During the past two decades, there current concept has evolved significantly that ventilator-induced lung injury (VILI) may not only impose a direct mechanical stress and subsequent injury to the lungs, but may also induce local as well as systemic inflammation responses, generally referred as biotrauma.1 Patients with ARDS often die of severe systemic inflammatory response syndrome (SIRS) and multiorgan dysfunction2 rather than refractory hypoxemia. Ranieri et al found that patients with less severe ARDS, i.e., a lung injury score of 2.5 or less, receiving ventilation with lung protective strategy involving low tidal volume (7.5 mL/kg PBW) and high PEEP could attenuate the pulmonary and systemic cytokine response compared with conventional ventilation with high tidal volume.3 Stuber et al found an increase in pro-inflammatory cytokines in the lung and plasma of patients with ARDS within 1 hour after switching the patients from a protective to non-protective ventilator strategy.4 The receptor for advanced glycation end-products (RAGE) was recently identified as a marker of injury to the alveolar type I epithelial cells5. Clinical studies showed that the plasma level of RAGE was associated with severity of lung injury and clinical outcome, and low tidal volume strategy ventilation accelerated the decline in plasma RAGE levels. These results suggest plasma RAGE level might be a reliable biomarker of alveolar epithelial injury in acute lung injury and may associated with ventilator induced lung injury6. Although, current approach to mechanical ventilation of a patient with ARDS emphasizes the use of lower tidal volumes with lower plateau pressures to avoid causing lung overdistension and ventilator associated lung injury (VILI)7; however, in the real world, some studies showed that strictly reduction of tidal volume to 6ml/kg PBW was modest in modern time, and was noticed only in patients with greater lung injury scores8. The benefit of VT strictly reduction to 6ml/kgPBW and its effect on VILI in patients with less severe ARDS whose Pplat are already below 30 cmH2O are controversy9. One of the possible solutions is to look at the biomarkers of injury to alveolar epithelial cells. Of these potentially promising markers, the receptor for advanced glycation end-product (RAGE) is of great interest.
We hypothesize that a strategy with strict low tidal volume in less severe ARDS and ALI patients with good compliance may be beneficial to this patient population. Therefore, we wish to propose a prospective single-center study to investigate the effect of mechanical ventilation strategy on the plasma level of RAGE in patients with less severe ARDS and acute lung injury.
Detailed description
During the past two decades, there current concept has evolved significantly that ventilator-induced lung injury (VILI) may not only impose a direct mechanical stress and subsequent injury to the lungs, but may also induce local as well as systemic inflammation responses, generally referred as biotrauma.1 Patients with ARDS often die of severe systemic inflammatory response syndrome (SIRS) and multiorgan dysfunction2 rather than refractory hypoxemia. Ranieri et al found that patients with less severe ARDS, i.e., a lung injury score of 2.5 or less, receiving ventilation with lung protective strategy involving low tidal volume (7.5 mL/kg PBW) and high PEEP could attenuate the pulmonary and systemic cytokine response compared with conventional ventilation with high tidal volume.3 Stuber et al found an increase in pro-inflammatory cytokines in the lung and plasma of patients with ARDS within 1 hour after switching the patients from a protective to non-protective ventilator strategy.4 The receptor for advanced glycation end-products (RAGE) was recently identified as a marker of injury to the alveolar type I epithelial cells5. Clinical studies showed that the plasma level of RAGE was associated with severity of lung injury and clinical outcome, and low tidal volume strategy ventilation accelerated the decline in plasma RAGE levels. These results suggest plasma RAGE level might be a reliable biomarker of alveolar epithelial injury in acute lung injury and may associated with ventilator induced lung injury6. Although, current approach to mechanical ventilation of a patient with ARDS emphasizes the use of lower tidal volumes with lower plateau pressures to avoid causing lung overdistension and ventilator associated lung injury (VILI)7; however, in the real world, some studies showed that strictly reduction of tidal volume to 6ml/kg PBW was modest in modern time, and was noticed only in patients with greater lung injury scores8. The benefit of VT strictly reduction to 6ml/kgPBW and its effect on VILI in patients with less severe ARDS whose Pplat are already below 30 cmH2O are controversy9. One of the possible solutions is to look at the biomarkers of injury to alveolar epithelial cells. Of these potentially promising markers, the receptor for advanced glycation end-product (RAGE) is of great interest.
We hypothesize that a strategy with strict low tidal volume in less severe ARDS and ALI patients with good compliance may be beneficial to this patient population. Therefore, we will to propose a prospective single-center study to investigate the effect of mechanical ventilation strategy on the plasma level of RAGE in patients with less severe ARDS and acute lung injury.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Other: check biomarker :RAGEAll patients meet ALI/less severe ARDS criteria |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All intubated and mechanically ventilated patients who meet the criteria of American-European Consensus Conference (AECC) criteria for ALI/ ARDS:
- Acute onset of illness Bilateral (patchy, diffuse, or homogeneous) infiltrates consistent with pulmonary edema PaO2/FiO2 <= 300 (corrected for altitude): (P/F <300 for ALI and P/F <200 for ARDS) No clinical evidence of left atrial hypertension
Key exclusion criteria (3 listed)
- 1. Age <18 years 2. Enrolled in other clinical trials 3. Had confirmed alternative diagnoses that would have different clinical course than ARDS/ALI, e.g., diffuse alveolar hemorrhage, vasculitis, interstitial pneumonitis, etc.
- 4. Congestive heart failure related pulmonary edema 5. Acute myocardial infarction 6. Pregnancy 7. Patients with definite contraindication to the use of low-tidal volume ventilation, e.g., increased intracranial pressure, tricyclic antidepressant overdose, etc.
- 8. The patient who meets inclusion criteria initially but rapidly improved within 24 hours of diagnosis of ARDS/ALI
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 |
|---|---|---|
| check biomarker :RAGEWe will check RAGE for all patients who have ARDS included in our study | Other | 1 |
Primary outcome
the effect of mechanical ventilation strategy on the plasma level of RAGE in patients with less severe ARDS and acute lung injury.
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2012.
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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.
Jih-Shuin Jerng, MD,PhD principal investigator
National Taiwan University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing check biomarker :RAGE in people with Acute Respiratory Distress Syndrome, run by National Taiwan University Hospital.
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 2 inclusion and 3 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 27 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
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 Jih-Shuin Jerng, MD,PhD (0972651075, jsjerng@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the effect of mechanical ventilation strategy on the plasma level of RAGE in patients with less severe ARDS and acute lung injury. (time frame: 7 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 27 Dec 2012.