Trial record 9 of 505 for:    "Acute respiratory distress syndrome"

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

This study is currently recruiting participants.
Verified April 2012 by Chinese PLA General Hospital
Sponsor:
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
Air Force General Hospital of the PLA
The 309 Hospital of People's Liberation Army
Information provided by (Responsible Party):
Chen Liang_An, Chinese PLA General Hospital
ClinicalTrials.gov Identifier:
NCT01391481
First received: July 8, 2011
Last updated: April 9, 2012
Last verified: April 2012
  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)

Resource links provided by NLM:


Further study details as provided by Chinese PLA General Hospital:

Primary Outcome Measures:
  • 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,


Secondary Outcome Measures:
  • 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
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01391481

Contacts
Contact: zhixin Liang, M.D. 86-10-13651205567 13651205567@163.com
Contact: Chen Yang, M.D. 86-10-18618333365 ycmarcia@hotmail.com

Locations
China, Beijing
Chinese PLA General Hospital Recruiting
Beijing, Beijing, China, 100853
306 Hospital of PLA Recruiting
Beijing, Beijing, China, 100000
Sponsors and Collaborators
Chinese PLA General Hospital
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
Air Force General Hospital of the PLA
The 309 Hospital of People's Liberation Army
Investigators
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, Adult
Acute Lung Injury
Respiratory Distress Syndrome, Newborn
Lung Injury
Wounds and Injuries
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Thoracic Injuries

ClinicalTrials.gov processed this record on April 17, 2014