Low dose inhaled nitric oxide in patients with acute lung injury
| ISRCTN | ISRCTN53268296 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN53268296 |
| Secondary identifying numbers | INOT06 |
- Submission date
- 18/11/2011
- Registration date
- 31/01/2012
- Last edited
- 31/01/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Plain English summary of protocol
Background and study aims
Acute respiratory distress syndrome (ARDS) is a disease in which the lungs are inflamed, wet and there is difficulty transmitting oxygen from the air that enters the lung as part of the breathing process into the blood. It has many causes including infectious and non-infectious. The objectives of this study were to add a gas called nitric oxide(NO) to the air that participants were breathing in order to raise the oxygen level in the blood in hopes of improving outcome in participants with ARDS.
Who can participate?
Patients aged 18 and over, regardless of sex, who have ARDS and are on a breathing machine (called a ventilator) in order to enable oxygen transfer into the blood.
What does the study involve?
The study compared inhaled nitric oxide (INO) added to the air the patient was breathing though the machine with a placebo nitrogen, a safe gas that makes up most of the air that we breathe and would have no effect on ARDS. All participants will receive the same treatment that they would have received for ARDS, even if they had not participated in the study. If patients were randomly allocated to the group receiving inhaled nitric oxide, this would have been the additional therapy.
What are the possible benefits and risks of participating?
By participating it is possible that the subject will have improved oxygenation and that this may lead to improved outcome. There are no anticipated potential side effects of the treatment when delivered at the doses that will be used in this study.
Where is the study run from?
There were 35 centers taking part in this trial and the lead center is St. Johns Mercy Hospital St. Louis, Missouri.
When is study starting and how long is it expected to run for?
The start date of the study was 1996 and the duration of the study was approximately 3 years. Recruitment of participants was until late summer/fall 1999.
Who is funding the study?
The study was funded by INO Therapeutics (Now called IKARIA). They paid the costs associated with the trial.
Who is the main contact?
Phil Dellinger
dellinger-phil@cooperhealth.edu
Contact information
Scientific
Cooper University Hospital
One Cooper Plaza
Camden, New Jersey
19102
United States of America
| Phone | +1 856 342 2632 |
|---|---|
| dellinger-phil@cooperhealth.edu |
Study information
| Study design | Multicenter randomized blinded placebo-controlled |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Low dose inhaled nitric oxide in patients with acute lung injury: a randomized controlled trial |
| Study objectives | To evaluate the clinical efficacy of low-dose (5-ppm) inhaled nitric oxide in patients with acute lung injury. |
| Ethics approval(s) | Human Subjects Committee (USA), 15 February 1996 |
| Health condition(s) or problem(s) studied | Acute lung injury |
| Intervention | Inhaled nitric oxide (5ppm) or placebo (nitrogen gas) is delivered with mechanical ventilator breaths until the patient is extubated or for a total of 28 days. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Nitric oxide |
| Primary outcome measure | Days alive and off mechanical ventilation |
| Secondary outcome measures | Pulmonary function including spirometry, lung volumes and diffusion of carbon monoxide evaluated at 6 months |
| Overall study start date | 27/03/1996 |
| Completion date | 08/09/1999 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 385 |
| Key inclusion criteria | 1. Mechanically ventilated patients with acute lung injury 2. Ratio of partial pressure of arterial oxygen (O2) to the fraction of inspired partial pressure of oxygen in arterial blood/fraction of inspired oxygen (Pa02/FiO2) ratio of 250 or less |
| Key exclusion criteria | Sepsis as the cause of the acute lung injury |
| Date of first enrolment | 27/03/1996 |
| Date of final enrolment | 08/09/1999 |
Locations
Countries of recruitment
- United States of America
Study participating centre
19102
United States of America
Sponsor information
Industry
c/o Ikaria Inc
Perryville III Corporate Park
53 Frontage Road
Hampton, New Jersey
08827
United States of America
| Website | http://www.ikaria.com |
|---|
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 07/04/2004 | Yes | No |
