Perfluorocarbon (PFC) Inhalation Treatment of Acute Lung Injury/Acute Respiratory Distress Syndrome
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Respiratory Distress Syndrome, Adult Acute Lung Injury |
Drug: Perfluorocarbon Drug: Sterile Water for Injection |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| 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) |
- oxygenation index, respiratory mechanics [ Time Frame: three years ] [ Designated as safety issue: Yes ]oxygenation index and respiratory mechanics will be abtained before and 1, 2, 4h after every inhalation,
- Survival [ Time Frame: three years ] [ Designated as safety issue: Yes ]ventilator-free days, 28-day mortality
| Estimated Enrollment: | 200 |
| Study Start Date: | August 2011 |
| Estimated Study Completion Date: | April 2015 |
| Estimated Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Perfluorocarbon |
Drug: Perfluorocarbon
Vaporized PFC Inhalation 100ml/8h for 5 days
|
| Placebo Comparator: Sterile Water for Injection |
Drug: Sterile Water for Injection
Inhalation of Sterile Water for Injection, 100ml/8h for 5 days
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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)
- 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
Contacts and Locations| Contact: zhixin Liang, M.D. | 86-10-13651205567 | 13651205567@163.com |
| Contact: Chen Yang, M.D. | 86-10-18618333365 | ycmarcia@hotmail.com |
| China, Beijing | |
| Chinese PLA General Hospital | Recruiting |
| Beijing, Beijing, China, 100853 | |
| 306 Hospital of PLA | Recruiting |
| Beijing, Beijing, China, 100000 | |
| Study Chair: | Liangan Chen, M.D. PHD. | Chinese PLA General Hospital |
More Information
No publications provided
| Responsible Party: | Chen Liang_An, M.D., Ph.D, Chinese PLA General Hospital |
| ClinicalTrials.gov Identifier: | NCT01391481 History of Changes |
| Other Study ID Numbers: | PLAGH-PFC |
| Study First Received: | July 8, 2011 |
| Last Updated: | April 9, 2012 |
| Health Authority: | China: Food and Drug Administration |
Keywords provided by Chinese PLA General Hospital:
|
Perfluorocarbon Acute Respiratory Distress Syndrome Acute lung injury |
Additional relevant MeSH terms:
|
Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury Lung Injury Lung Diseases Respiratory Tract Diseases |
Respiration Disorders Infant, Premature, Diseases Infant, Newborn, Diseases Thoracic Injuries Wounds and Injuries |
ClinicalTrials.gov processed this record on May 16, 2013