VOLCADREP: Evaluation of the Lung Capillary Blood Volume in Children With Sickle Cell Disease

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Completed

CT.gov ID

NCT00560261

Collaborator

(none)

120

Enrollment

Location

Arms

Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Sickle cell disease (SCD) is the most common inherited disease of the world affecting African and Caribbean populations. SCD is caused by the homozygous inheritance of the gene for sickle hemoglobin (HbS). Most patients with SCD develop abnormal pulmonary function characterized by airway obstruction, restrictive lung disease, abnormal diffusing capacity, hypoxemia and pulmonary hypertension In healthy subjects, lung capillary blood volume (Qc) and membrane diffusing capacity (Dm) can be accurately measured by the nitric oxide-carbon monoxide (NO-CO) method. We propose to study, for the first time, lung capillary blood volume and alveolar membrane diffusing capacity, using the NO-CO method, in children with SCD aged of at least 6 years Early determination of lung function and pulmonary circulation in children with SCD is very important, not only for the understanding of physiopathologic mechanisms of the disease but also for a better therapeutic management of these children.

Condition or Disease	Intervention/Treatment	Phase
Sickle Cell Disease	Other: NO-CO inhalation and expiration Other: NO-CO inhalation and expiration	Phase 3

Detailed Description

We propose to study, for the first time, lung capillary blood volume and alveolar membrane diffusing capacity, using the NO-CO method, in children with SCD aged of at least 6 years. We will compare lung function and measurement of Qc and Dm in 2 groups of 120 subjects, one group of SCD children, and the other of normal children matched on age and ethnic origin. Measurement of lung capillary blood will be measured twice, to assess short term reproducibility. The measurement will be done in sitting position and lying down for one part of subjects, and at rest and during a moderate rectangular exercise for the other part of subjects. These different tests are designed to assess the physiological adaptation of pulmonary circulation in these two populations of children. Combined with complete lung function measurements, echocardiographic assessment of pulmonary hemodynamics, and measurement of exhaled nitric oxide, these evaluations will lead to a better understanding of pathophysiology of lung injury in SCD. The study will be completes at Robert Debré Hospital, in close collaboration with Sickle Cell Disease Center and Physiology Department. Children will be included after informed consent signed, as legally prescribed.

Study Design

Study Type:

Interventional

Actual Enrollment :

120 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Evaluation of the Lung Capillary Blood Volume in Children With Sickle Cell Disease

Study Start Date :

Feb 1, 2008

Actual Primary Completion Date :

Feb 1, 2012

Actual Study Completion Date :

Feb 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1:Children with sickle cell disease NO-CO inhalation and expiration: Children with sickle cell disease	Other: NO-CO inhalation and expiration NO-CO inhalation and expiration
Active Comparator: 2: Healthy volunteers NO-CO inhalation and expiration: Healthy volunteers	Other: NO-CO inhalation and expiration NO-CO inhalation and expiration

Arm

Intervention/Treatment

Experimental: 1:Children with sickle cell disease

NO-CO inhalation and expiration: Children with sickle cell disease

Other: NO-CO inhalation and expiration

NO-CO inhalation and expiration

Active Comparator: 2: Healthy volunteers

NO-CO inhalation and expiration: Healthy volunteers

Other: NO-CO inhalation and expiration

NO-CO inhalation and expiration

Outcome Measures

Primary Outcome Measures

Study of lung capillary blood volume and alveolar membrane diffusing capacity using NO-CO method [The day of the measure]

Secondary Outcome Measures

Respiratory physiopathology's study in sickle cell disease [At the induction of the study]
Valid alveolar membrane diffusing capacity using NO-CO in children with or without sickle cell disease [At the induction of the study]
Purpose respiratory function follow up in sickle cell disease child [At the induction of the study]
Find relationship between these vascular abnormalities and NO metabolism [At the induction of the study]

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Children between 6 and 18 years
Sickle cell disease( SS,SC, SBETA O, SDpunjab) and control without sickle cell disease
Social insurance
Signed informed consent

Exclusion Criteria:

Respiratory disease other tha asthma
Cardiac disease
Encephalopathy
G6PD deficiency
Consent not signed

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hopital Robert DEBRE	Paris		France	75019

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

Principal Investigator: Florence MISSUD, Md, Assistance Publique - Hôpitaux de Paris

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Assistance Publique - Hôpitaux de Paris

ClinicalTrials.gov Identifier:

NCT00560261

Other Study ID Numbers:

P061013
2007-A00913-50

First Posted:

Nov 19, 2007

Last Update Posted:

Aug 3, 2012

Last Verified:

Jul 1, 2012

Keywords provided by Assistance Publique - Hôpitaux de Paris

Sickle cell disease;

Lung capillary blood volume;

Children

Additional relevant MeSH terms:

Anemia, Sickle Cell

Study Results

No Results Posted as of Aug 3, 2012