Perfluorocarbon (PFC) Inhalation Treatment of Acute Lung Injury/Acute Respiratory Distress Syndrome
The Randomized Controlled Trial (RCT) on the Vaporized Perfluorocarbon (PFC) Inhalation Treatment of Acute Respiratory Distress Syndrome With the Invasive Mechanical Ventilation（IMV）
1 other identifier
interventional
200
1 country
2
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2011
Typical duration for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 8, 2011
CompletedFirst Posted
Study publicly available on registry
July 12, 2011
CompletedStudy Start
First participant enrolled
August 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedApril 10, 2012
April 1, 2012
1.7 years
July 8, 2011
April 9, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
oxygenation index, respiratory mechanics
oxygenation index and respiratory mechanics will be abtained before and 1, 2, 4h after every inhalation,
three years
Secondary Outcomes (1)
Survival
three years
Study Arms (2)
Perfluorocarbon
EXPERIMENTALSterile Water for Injection
PLACEBO COMPARATORInterventions
Inhalation of Sterile Water for Injection, 100ml/8h for 5 days
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Chinese PLA General Hospitallead
- The Second Artillery General Hospitalcollaborator
- The 306 Hospital of People's Liberation Armycollaborator
- First Hospitals affiliated to the China PLA General Hospitalcollaborator
- General Hospital of Chinese Armed Police Forcescollaborator
- Beijing Shijitan Hospital, Capital Medical Universitycollaborator
- Air Force General Hospital of the PLAcollaborator
- 309th Hospital of Chinese People's Liberation Armycollaborator
Study Sites (2)
306 Hospital of PLA
Beijing, Beijing Municipality, 100000, China
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Liangan Chen, M.D. PHD.
Chinese PLA General Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D., Ph.D
Study Record Dates
First Submitted
July 8, 2011
First Posted
July 12, 2011
Study Start
August 1, 2011
Primary Completion
April 1, 2013
Study Completion
April 1, 2015
Last Updated
April 10, 2012
Record last verified: 2012-04