Perfluorocarbon (PFC) Inhalation Treatment of Acute Lung Injury/Acute Respiratory Distress Syndrome

Acute Lung Injury Clinical Trial

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）

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01391481
• Other study ID #: PLAGH-PFC
• Status: Recruiting
• Phase: Phase 2
• First received: July 8, 2011
• Last updated: April 9, 2012
• Start date: August 2011
• Est. completion date: April 2015

Study information

• Verified date: April 2012
• Source: Chinese PLA General Hospital
• Contact: zhixin Liang, M.D.
• Phone: 86-10-13651205567
• Email: 13651205567[@]163.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: April 2015
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Lung Injury
• Lung Injury
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Syndrome

Intervention

Drug:
• Perfluorocarbon
Vaporized PFC Inhalation 100ml/8h for 5 days
• Sterile Water for Injection
Inhalation of Sterile Water for Injection, 100ml/8h for 5 days

Locations

Country	Name	City	State
China	306 Hospital of PLA	Beijing	Beijing
China	Chinese PLA General Hospital	Beijing	Beijing

Sponsors (8)

Lead Sponsor	Collaborator
Chinese PLA General Hospital	309th Hospital of Chinese People's Liberation Army, Air Force General Hospital of the PLA, Beijing Shijitan Hospital, First Hospitals affiliated to the China PLA General Hospital, General Hospital of Chinese Armed Police Forces, The 306 Hospital of People's Liberation Army, The Second Artillery General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	oxygenation index, respiratory mechanics	oxygenation index and respiratory mechanics will be abtained before and 1, 2, 4h after every inhalation,	three years	Yes
Secondary	Survival	ventilator-free days, 28-day mortality	three years	Yes