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

Primary Purpose

Respiratory Distress Syndrome, Adult, Acute Lung Injury

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Perfluorocarbon

Sterile Water for Injection

About this trial

This is an interventional treatment trial for Respiratory Distress Syndrome, Adult focused on measuring Perfluorocarbon, Acute Respiratory Distress Syndrome, Acute lung injury

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

306 Hospital of PLARecruiting
Chinese PLA General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Perfluorocarbon

Sterile Water for Injection

Arm Description

Outcomes

Primary Outcome Measures

oxygenation index, respiratory mechanics

oxygenation index and respiratory mechanics will be abtained before and 1, 2, 4h after every inhalation,

Secondary Outcome Measures

Survival

ventilator-free days, 28-day mortality

Full Information

NCT ID

NCT01391481

First Posted

July 8, 2011

Last Updated

April 9, 2012

Sponsor

Chinese PLA General Hospital

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, Capital Medical University, Air Force General Hospital of the PLA, 309th Hospital of Chinese People's Liberation Army

1. Study Identification

Unique Protocol Identification Number

NCT01391481

Brief Title

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

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）

Study Type

Interventional

2. Study Status

Record Verification Date

April 2012

Overall Recruitment Status

Unknown status

Study Start Date

August 2011 (undefined)

Primary Completion Date

April 2013 (Anticipated)

Study Completion Date

April 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Chinese PLA General Hospital

Collaborators

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Respiratory Distress Syndrome, Adult, Acute Lung Injury

Keywords

Perfluorocarbon, Acute Respiratory Distress Syndrome, Acute lung injury

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

Participant

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Perfluorocarbon

Arm Type

Experimental

Arm Title

Sterile Water for Injection

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Perfluorocarbon

Intervention Description

Vaporized PFC Inhalation 100ml/8h for 5 days

Intervention Type

Drug

Intervention Name(s)

Sterile Water for Injection

Intervention Description

Inhalation of Sterile Water for Injection, 100ml/8h for 5 days

Primary Outcome Measure Information:

Title

oxygenation index, respiratory mechanics

Description

oxygenation index and respiratory mechanics will be abtained before and 1, 2, 4h after every inhalation,

Time Frame

three years

Secondary Outcome Measure Information:

Title

Survival

Description

ventilator-free days, 28-day mortality

Time Frame

three years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

zhixin Liang, M.D.

Phone

86-10-13651205567

13651205567@163.com

First Name & Middle Initial & Last Name or Official Title & Degree

Chen Yang, M.D.

Phone

86-10-18618333365

ycmarcia@hotmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Liangan Chen, M.D. PHD.

Organizational Affiliation

Chinese PLA General Hospital

Official's Role

Study Chair

Facility Information:

Facility Name

306 Hospital of PLA

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100000

Country

China

Individual Site Status

Recruiting

Facility Name

Chinese PLA General Hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100853

Country

China

Individual Site Status

Recruiting

12. IPD Sharing Statement

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

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