Ignite Creation Date:
2024-05-05 @ 7:48 PM
Last Modification Date:
2024-10-26 @ 9:54 AM
Study NCT ID:
NCT00748423
Status:
COMPLETED
Last Update Posted:
2013-08-02
First Post:
2008-09-05
Brief Title:
Effect of Inhaled Nitric Oxide in Acute Chest Syndrome INOSTA Study
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Bicentric Study of the Effect of Inhaled Nitric Oxide Compared to Placebo in Acute Chest Syndrome of Adult Sickle Cell Patients
Status:
COMPLETED
Status Verified Date:
2013-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
INOSTA
Brief Summary:
Acute chest syndrome ACS is a frequent and potentially life-threatening pulmonary illness It is a complication of sickle cell disease and is the leading cause of death from this disease in adults Several pathologic processes are recognized causes of ACS including infectious diseases hypoventilation secondary to chest pain in situ thrombosis and pulmonary fat embolism Inhaled nitric oxide iNO has been shown to be a pulmonary vasodilatator with minimal systemic effects and has also been shown to improve gas exchange in both animal and human acute lung injury ALI
The combined effects of iNO gas of improving pulmonary ventilation to perfusion matching reducing alveolar and systemic inflammation modulate the course of acute chest syndrome which combine the physiopathology of vaso-occlusive crisis and acute lung injury
We hypothesise inhaled NO will improve oxygenation and clinical outcome of sickle cell disease patients with acute chest syndrome
The combined effects of iNO gas of improving pulmonary ventilation to perfusion matching reducing alveolar and systemic inflammation modulate the course of acute chest syndrome which combine the physiopathology of vaso-occlusive crisis and acute lung injury
We hypothesise inhaled NO will improve oxygenation and clinical outcome of sickle cell disease patients with acute chest syndrome
Detailed Description:
Objectives To compare the outcome and duration of acute chest syndrome ACS in patients with sickle cell disease SCD treated with iNO to that of similar episodes experienced by patients which receive a placebo
Study design Bi-center prospective randomized controlled clinical trial
Enrollment 24 months
Patients will be treated for 72 hours
Patients will be followed for 15 days or until discharged home
Sample size
The study will accrue a maximum of 240 patients
Progress of the trial will be reviewed by an independent data and safety monitoring committee to determine if randomization should stop for safety reasons
Study design Bi-center prospective randomized controlled clinical trial
Enrollment 24 months
Patients will be treated for 72 hours
Patients will be followed for 15 days or until discharged home
Sample size
The study will accrue a maximum of 240 patients
Progress of the trial will be reviewed by an independent data and safety monitoring committee to determine if randomization should stop for safety reasons
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None