Effect of Inhaled Nitric Oxide in Acute Chest Syndrome (INOSTA Study) (INOSTA)
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.
|Sickle Cell Disease Acute Chest Syndrome||Drug: Nitric Oxide Drug: Placebo||Phase 2 Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
|Official Title:||Bicentric Study of the Effect of Inhaled Nitric Oxide Compared to Placebo in Acute Chest Syndrome of Adult Sickle Cell Patients|
- Percentage of patients with treatment failure [ Time Frame: at day 3 ]
- Proportion of hypoxemic patients defined by a PaO2/FiO2 ratio < 300 [ Time Frame: at day 3 ]
- Variation of pulmonary arterial systolic pressure evaluated by echocardiography [ Time Frame: at day 1, day 3 and end of study ]
- Length of hospitalisation [ Time Frame: from day 0 to day 15 (max) ]
- Pain assessment and the cumulative dose of parenteral opioids per body weight [ Time Frame: during the first three days and during entire hospitalization ]
- Proportion of patients requiring transfusion therapy (simple or exchange) [ Time Frame: from day 1 to end of study ]
|Study Start Date:||December 2008|
|Study Completion Date:||December 2012|
|Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Nitric Oxide in nitrogen
Drug: Nitric Oxide
NO in inhalation for 3 days
Placebo Comparator: 2
Placebo in inhalation for 3 days
Other Name: "Nitrogen" placebo
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
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00748423
|Réanimation Médicale, Hôpital A Chenevier-H Mondor|
|Creteil, France, 94 000|
|Principal Investigator:||MAITRE Bernard, MD, PHD||Assistance Publique - Hôpitaux de Paris|