Respiratory Distress Syndrome, AdultPhase 2NCT01391481
Perfluorocarbon (PFC) Inhalation Treatment of Acute Lung Injury/Acute Respiratory Distress Syndrome
A Phase 2 study testing Perfluorocarbon and Sterile Water for Injection in people with Respiratory Distress Syndrome, Adult and Acute Lung Injury, run by Chinese PLA General Hospital at 2 sites in China.
Trial summary
PFCs (perfluorocarbons, PFC), an ideal liquid respiratory media, has special chemical and biological properties, including high solubility of gas, swiftness of carrying and release, low surface tension, high proportion, almost non-absorbing and non-metabolic characteristics in the body. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Respiratory Distress Syndrome, Adult, Acute Lung Injury
- What is being tested?
- Perfluorocarbon and Sterile Water for Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 2 sitesChina
- Study dates
- Aug 2011to Apr 2015
- Phase
- Phase 2
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18-75 years old
- Some clear risk aetiological agents of acute respiratory distress syndrome
- Acute onset, with corresponding clinical manifestations
- PaO2/FiO2 ≤ 300mmHg
- Chest radiograph or chest computerized tomography prompting bilateral pulmonary infiltrate shadow
- pulmonary capillary wedge pressure (PCWP) ≤ 18 mmHg or clinical cardiogenic pulmonary edema can be excluded
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- respiratory rate (RR) ≥ 30bpm and (or) respiratory distress
- requiring tracheal intubation or tracheostomy for invasive mechanical ventilation
- or have received invasive mechanical ventilation time ≤ 3 days
Who cannot join
- Age: < 18 years old or > 75 years old
- During the early stage of the treatment, the use of mechanical ventilation for more than 3 days other than ALI/ARDS for reasons
- Lung parenchyma and airway surgery carried out within 30 days of the screening period
- Severe arrhythmia and myocardial ischemia after cardiopulmonary resuscitation
- Systolic blood pressure < 90 mm Hg, and can not maintain its stability with intravenous infusion and vasopressor drugs
- Intubation due to interstitial lung disease (E.g., sarcoidosis, idiopathic pulmonary fibrosis)
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- Any active pneumothorax or mediastinal emphysema
- Risk factors leading to the death within 3 months in addition to ALI/ARDS during the screening period (E.g., end-stage cancer)
- Of perfluorocarbons' allergies
- Pregnant, breastfeeding women
- Attending other clinical trial within 30 days of the screening period
- Severe organ dysfunction (Marshall score ≥ 3 or Sequential Organ Failure Assessment（SOFA） score≥ 3, including serious liver and kidney dysfunction, upper gastrointestinal hemorrhage, etc.)
- Acute Physiology and Chronic Health Evaluation（APACHE） II score ≥ 30, high risk of death
- The researchers consider other situations not suitable for the case to participate in the study
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
306 Hospital of PLA
Beijing, Beijing Municipality, 100000
- Recruiting
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
About this study
Official title: The Randomized Controlled Trial (RCT) on the Vaporized Perfluorocarbon (PFC) Inhalation Treatment of Acute Respiratory Distress Syndrome With the Invasive Mechanical Ventilation（IMV）
PFCs (perfluorocarbons, PFC), an ideal liquid respiratory media, has special chemical and biological properties, including high solubility of gas, swiftness of carrying and release, low surface tension, high proportion, almost non-absorbing and non-metabolic characteristics in the body. On the basis of the strong animal data suggesting the efficacy of PFC vapor inhalation in models of lung injury, we performed a randomized clinical trial comparing PFC vapor inhalation with conventional mechanical ventilation（CMV）in patients with Acute Lung Injury/Acute Respiratory Distress Syndrome（ALI/ARDS）. The investigators will apply the Invasive Mechanical Ventilation (IMV) to the vaporized perfluorocarbon inhalation, objectively evaluate its curative effect on the acute respiratory distress syndrome, and meanwhile assess the safety of PFC.
Read the detailed description
Based on the invasive mechanical ventilation (IMV) treatment of ALI/ARDS, the therapeutic action of vaporized PFC inhalation will be evaluated on the treatment of ALI/ARDS patients, and the safety of vaporized PFC inhalation on the treatment of ALI/ARDS. The Test group will make a timing and fix quantify inhalation of PFC, while the control group will be treated with the inhalation of water for injection. The general condition of patients will be assessed by monitoring their vital signs, hematology testing and APACHE II score, etc. Main outcome measures include the oxygenation index, respiratory mechanics; secondary outcomes include ventilator-free days, 28-day mortality and so on.
- Being tested
- Perfluorocarbon, Sterile Water for Injection
- Keywords
- Perfluorocarbon, Acute Respiratory Distress Syndrome, Acute lung injury
- Medical subject headings
- Respiratory Distress Syndrome, Acute Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PerfluorocarbonDrug
Vaporized PFC Inhalation 100ml/8h for 5 days
Sterile Water for InjectionDrug
Inhalation of Sterile Water for Injection, 100ml/8h for 5 days
| Study group | Role | What they receive |
|---|---|---|
| Perfluorocarbon | Experimental | Not described Receives: Drug: Perfluorocarbon |
| Sterile Water for Injection | Placebo comparator | Not described Receives: Drug: Sterile Water for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
oxygenation index, respiratory mechanics
oxygenation index and respiratory mechanics will be abtained before and 1, 2, 4h after every inhalation,
Measured: three years
Secondary outcomes (1)
Survival
ventilator-free days, 28-day mortality
Measured: three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2011 (estimated)
- Study startAug 2011
- Primary completionApr 2013 (estimated)
- Study completionApr 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Distress Syndrome, AdultStudies of the same condition, open and under way.
- More trials run by Chinese PLA General 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Second Artillery General Hospital, The 306 Hospital of People's Liberation Army, First Hospitals affiliated to the China PLA General Hospital, General Hospital of Chinese Armed Police Forces, Beijing Shijitan Hospital, Capital Medical University, Air Force General Hospital of the PLA, 309th Hospital of Chinese People's Liberation Army
- Responsible party
- Principal investigator, Chen Liang_An, Chinese PLA General Hospital
- Investigators
- Liangan Chen, M.D. PHD., Study chair, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01391481
- Sponsor's protocol ID
- PLAGH-PFC
- Status last verified
- Apr 2012
- First submitted
- 8 Jul 2011
- Last updated
- 10 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Randomized Controlled Trial (RCT) on the Vaporized Perfluorocarbon (PFC) Inhalation Treatment of Acute Respiratory Distress Syndrome With the Invasive Mechanical Ventilation（IMV）
- ClinicalTrials.gov ID
- NCT01391481
- Acronym / sponsor ID
- PLAGH-PFC
- Keywords
- Perfluorocarbon, Acute Respiratory Distress Syndrome, Acute lung injury
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Collaborators
- The Second Artillery General Hospital, The 306 Hospital of People's Liberation Army, First Hospitals affiliated to the China PLA General Hospital, General Hospital of Chinese Armed Police Forces, Beijing Shijitan Hospital, Capital Medical University, Air Force General Hospital of the PLA, 309th Hospital of Chinese People's Liberation Army
- Study start
- Aug 2011
- Primary completion
- Apr 2013 (estimated)
- Study completion
- Apr 2015 (estimated)
- First posted
- 12 Jul 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.
PFCs (perfluorocarbons, PFC), an ideal liquid respiratory media, has special chemical and biological properties, including high solubility of gas, swiftness of carrying and release, low surface tension, high proportion, almost non-absorbing and non-metabolic characteristics in the body. On the basis of the strong animal data suggesting the efficacy of PFC vapor inhalation in models of lung injury, we performed a randomized clinical trial comparing PFC vapor inhalation with conventional mechanical ventilation（CMV）in patients with Acute Lung Injury/Acute Respiratory Distress Syndrome（ALI/ARDS）. The investigators will apply the Invasive Mechanical Ventilation (IMV) to the vaporized perfluorocarbon inhalation, objectively evaluate its curative effect on the acute respiratory distress syndrome, and meanwhile assess the safety of PFC.
Detailed description
Based on the invasive mechanical ventilation (IMV) treatment of ALI/ARDS, the therapeutic action of vaporized PFC inhalation will be evaluated on the treatment of ALI/ARDS patients, and the safety of vaporized PFC inhalation on the treatment of ALI/ARDS. The Test group will make a timing and fix quantify inhalation of PFC, while the control group will be treated with the inhalation of water for injection. The general condition of patients will be assessed by monitoring their vital signs, hematology testing and APACHE II score, etc. Main outcome measures include the oxygenation index, respiratory mechanics; secondary outcomes include ventilator-free days, 28-day mortality and so on.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Perfluorocarbon | Experimental | Drug: Perfluorocarbon |
| Sterile Water for Injection | Placebo comparator | Drug: Sterile Water for Injection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age: 18-75 years old
- Some clear risk aetiological agents of acute respiratory distress syndrome
- Acute onset, with corresponding clinical manifestations
- PaO2/FiO2 ≤ 300mmHg
- Chest radiograph or chest computerized tomography prompting bilateral pulmonary infiltrate shadow
Key exclusion criteria (14 listed)
- Age: < 18 years old or > 75 years old
- During the early stage of the treatment, the use of mechanical ventilation for more than 3 days other than ALI/ARDS for reasons
- Lung parenchyma and airway surgery carried out within 30 days of the screening period
- Severe arrhythmia and myocardial ischemia after cardiopulmonary resuscitation
- Systolic blood pressure < 90 mm Hg, and can not maintain its stability with intravenous infusion and vasopressor drugs
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 |
|---|---|---|
| PerfluorocarbonVaporized PFC Inhalation 100ml/8h for 5 days | Drug | Perfluorocarbon |
| Sterile Water for InjectionInhalation of Sterile Water for Injection, 100ml/8h for 5 days | Drug | Sterile Water for Injection |
Primary outcome
oxygenation index, respiratory mechanics
Time frame: three years
oxygenation index and respiratory mechanics will be abtained before and 1, 2, 4h after every inhalation,
1 secondary outcome
Survival
Time frame: three years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 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.
Liangan Chen, M.D. PHD. study chair
Chinese PLA General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Perfluorocarbon and Sterile Water for Injection in people with Respiratory Distress Syndrome, Adult and Acute Lung Injury, run by Chinese PLA General Hospital at 2 sites in China.
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 9 inclusion and 14 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 10 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 zhixin Liang, M.D. (86-10-13651205567, 13651205567@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
oxygenation index, respiratory mechanics (time frame: three years). 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 10 Apr 2012; AzTrials last refreshed its copy on 8 Nov 2026.