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

NCT ID: NCT00748423

Last Updated: 2013-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2012-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Sickle Cell Disease Acute Chest Syndrome

Keywords

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Inhaled drug Acute lung injury Nitric oxide Sickle cell

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Nitric Oxide in nitrogen

Group Type EXPERIMENTAL

Nitric Oxide

Intervention Type DRUG

NO in inhalation for 3 days

2

Nitrogen

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo in inhalation for 3 days

Interventions

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Nitric Oxide

NO in inhalation for 3 days

Intervention Type DRUG

Placebo

Placebo in inhalation for 3 days

Intervention Type DRUG

Other Intervention Names

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"Nitrogen" placebo

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mallinckrodt

INDUSTRY

Sponsor Role collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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MAITRE Bernard, MD, PHD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

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Réanimation Médicale, Hôpital A Chenevier-H Mondor

Créteil, , France

Site Status

Countries

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France

References

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Maitre B, Djibre M, Katsahian S, Habibi A, Stankovic Stojanovic K, Khellaf M, Bourgeon I, Lionnet F, Charles-Nelson A, Brochard L, Lemaire F, Galacteros F, Brun-Buisson C, Fartoukh M, Mekontso Dessap A. Inhaled nitric oxide for acute chest syndrome in adult sickle cell patients: a randomized controlled study. Intensive Care Med. 2015 Dec;41(12):2121-9. doi: 10.1007/s00134-015-4060-2. Epub 2015 Oct 2.

Reference Type DERIVED
PMID: 26431718 (View on PubMed)

Other Identifiers

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P060701

Identifier Type: -

Identifier Source: org_study_id