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）

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.

Study Overview

• Status: Unknown
• Conditions: Acute Lung Injury; Respiratory Distress Syndrome, Adult
• Intervention / Treatment: Drug: Perfluorocarbon; Drug: Sterile Water for Injection

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 Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100853
      • Recruiting
      • Chinese PLA General Hospital
    • Beijing, Beijing, China, 100000
      • Recruiting
      • 306 Hospital of PLA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
oxygenation index, respiratory mechanics	oxygenation index and respiratory mechanics will be abtained before and 1, 2, 4h after every inhalation,	three years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival	ventilator-free days, 28-day mortality	three years

Collaborators and Investigators

• Sponsor: Chinese PLA General Hospital
• Collaborators: General Hospital of Chinese Armed Police Forces; Beijing Shijitan Hospital, Capital Medical University; 309th Hospital of Chinese People's Liberation Army; Air Force General Hospital of the PLA; First Hospitals affiliated to the China PLA General Hospital; The Second Artillery General Hospital; The 306 Hospital of People's Liberation Army
• Investigators: Study Chair: Liangan Chen, M.D. PHD., Chinese PLA General Hospital

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Anticipated): April 1, 2013
• Study Completion (Anticipated): April 1, 2015

Study Registration Dates

• First Submitted: July 8, 2011
• First Submitted That Met QC Criteria: July 11, 2011
• First Posted (Estimate): July 12, 2011

Study Record Updates

• Last Update Posted (Estimate): April 10, 2012
• Last Update Submitted That Met QC Criteria: April 9, 2012
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Keywords: Acute Respiratory Distress Syndrome; Acute lung injury; Perfluorocarbon
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Wounds and Injuries; Disease; Infant, Newborn, Diseases; Infant, Premature, Diseases; Thoracic Injuries; Syndrome; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Lung Injury
• Other Study ID Numbers: PLAGH-PFC