Clinical Trial: Nitric Oxide Therapy for Acute Chest Syndrome in Sickle Cell Disease Children

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Nitric Oxide Therapy for Acute Chest Syndrome in Sickle Cell Disease Children: Randomized, Double Blind Placebo-controlled Concept-proof Trial

Brief Summary: Acute chest syndrome is a severe sickle cell disease complication in children requiring blood transfusion therapy to prevent acute respiratory failure and death. Nitric oxide is a potent vasodilator that could reverse pulmonary vascular occlusion and restore normal oxygenation. The randomized trial will test that hypothesis.

Detailed Summary: Acute chest syndrome is a severe sickle cell disease complication in children requiring blood transfusion therapy to prevent acute respiratory failure and death. Nitric oxide is a potent vasodilator that could reverse pulmonary vascular occlusion and restore normal oxygenation. The randomized trial will test that hypothesis in a prospective randomized double-blind placebo controlled study. 50 children in two years will be included: 25 in each arm.
Sponsor: Assistance Publique - Hôpitaux de Paris

Current Primary Outcome: We will observe the patient's transfusional needs under nitric oxide (MONOXYDE AZOTE) versus placebo inhaled therapy to evaluate inhaled MOXYDE AZOTE efficacy on improving oxygenation (transcutaneous O2 superior to 92% ) [ Time Frame: Oxygenation improvement (transcutaneous O2 superior to 92%) after Gas inhalation will be evaluate 2hours after inclusion and therafter every 2 hours until 12 hours therapy and then every six hours for 3days and then once a day till hospital discharge ]

Original Primary Outcome: We will observe the patient's transfusional needs under NO versus placebo inhaled therapy to evaluate inhaled NO efficacy on improving oxygenation (transcutaneous O2 superior to 92% ) [ Time Frame: Oxygenation improvement (transcutaneous O2 superior to 92%) after Gas inhalation will be evaluate 2hours after inclusion and therafter every 2 hours until 12 hours therapy and then every six hours for 3days and then once a day till hospital discharge ]

Current Secondary Outcome:

  • Number of blood transfusions and total transfused blood volume [ Time Frame: 7 to 10 days ]
  • Quantity of Pain-killer drugs required and particularly OPIOIDS [ Time Frame: 7 to 10 days ]
  • Duration of Nitric oxide therapy [ Time Frame: after 7 to 10 days ]
  • Duration of OXYGENOTHERAPY [ Time Frame: 7 to 10 days ]


Original Secondary Outcome: Same as current

Information By: Assistance Publique - Hôpitaux de Paris

Dates:
Date Received: October 21, 2009
Date Started: June 2010
Date Completion:
Last Updated: December 3, 2014
Last Verified: August 2013