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NCT Number: NCT00748423

Effect of Inhaled Nitric Oxide in Acute Chest Syndrome (INOSTA Study)

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.

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Key information

Conditions

Sickle Cell Disease Acute Chest Syndrome Acute Lung Injury Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Anemia, Sickle Cell Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinopathies Lung Diseases Lung Injury Respiration Disorders Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Réanimation Médicale, Hôpital A Chenevier-H Mondor

Créteil, 94 000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with sickle cell disease (Hemoglobin genotypes characterized by standard procedures as homozygous hemoglobin SS, hemoglobin SC, and S beta thalassemia)
  • Diagnosis of acute chest syndrome based on the presence of fever, dyspnea or chest pain, associated with new pulmonary infiltrates on chest X-ray

Exclusion criteria

  • Patient has been hospitalised < 14 days ago
  • Patients presenting with clinically diagnosed bacterial infections
  • Patients who have received an exchange transfusion in the last 30 days or are in a transfusion program.
  • Current pregnancy or lactation
  • Patient who is currently enrolled in any other investigational drug study
  • Previous participation in this study
  • Any of the following medical conditions:
  • Immediate need of ventilatory support wih orotracheal intubation
  • Hemodynamic instability

Treatment and study plan

nitric oxide

Drug

NO in inhalation for 3 days

Placebo

Drug

Placebo in inhalation for 3 days

Other names: "Nitrogen" placebo

Primary outcomes

  1. Percentage of patients with treatment failure

    Time frame: at day 3

Secondary outcomes

  1. Proportion of hypoxemic patients defined by a PaO2/FiO2 ratio < 300

    Time frame: at day 3

  2. Variation of pulmonary arterial systolic pressure evaluated by echocardiography

    Time frame: at day 1, day 3 and end of study

  3. Length of hospitalisation

    Time frame: from day 0 to day 15 (max)

  4. Pain assessment and the cumulative dose of parenteral opioids per body weight

    Time frame: during the first three days and during entire hospitalization

  5. Proportion of patients requiring transfusion therapy (simple or exchange)

    Time frame: from day 1 to end of study

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Mallinckrodt

Registry information

Official study title

Bicentric Study of the Effect of Inhaled Nitric Oxide Compared to Placebo in Acute Chest Syndrome of Adult Sickle Cell Patients

Acronym: INOSTA

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Sep 8, 2008
Registry last updated
Aug 2, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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