title: High-dose Oral Ambroxol for Early Treatment of Pulmonary Acute Respiratory Distress Syndrome: an Exploratory, Randomized, Controlled Pilot Trial.
abstract: OBJECTIVE
  To evaluate efficacy of high-dose oral ambroxol in acute respiratory distress syndrome (ARDS) with respect to ventilator-free days (VFD).
  
  
  METHODS
  Prospective, randomized, placebo-controlled, blinded pilot trial.
  
  
  METHODS
  Sixty-six mechanically ventilated patients (1 month to 12 years) with ARDS who were hand-ventilated for <24 hr before pediatric intensive care unit admission.
  
  
  METHODS
  Patients randomized to oral ambroxol (40 mg/kg/day, in four divided doses) (n = 32) or placebo (n = 34) until 10 days, extubation or death whichever is earlier.
  
  
  RESULTS
  Majority (91%) had pneumonia and bronchiolitis. Two study groups were similar in baseline characteristics. Mean partial pressure of arterial oxygen/fraction of inspired oxygen and oxygenation index were >175 and <10, respectively, with no difference in the two study groups. VFD were similar in the two study groups. Overall mortality was 26%. No adverse events were noted with ambroxol.
  
  
  CONCLUSIONS
  Among ventilated pulmonary ARDS patients with oxygenation index of <10, mortality was 26%. Ambroxol did not improve VFD. Study with higher and more frequently administered doses of ambroxol in larger sample is suggested after having generated relevant pharmacokinetic data among critically ill children.
authors.affiliation: All India Institute of Medical Sciences, Patna-801507, India baranwal1970@gmail.com.
authors.forename: Arun K
authors.initials: AK
authors.lastname: Baranwal
authors.affiliation: Postgraduate Institute of Medical Education and Research, Chandigarh-160012, India.
authors.forename: Aparna S
authors.initials: AS
authors.lastname: Murthy
authors.affiliation: Postgraduate Institute of Medical Education and Research, Chandigarh-160012, India.
authors.forename: Sunit C
authors.initials: SC
authors.lastname: Singhi
mesh_terms: D000284:Administration, Oral; D000551:Ambroxol / Q000008:administration & dosage*; D002648:Child; D002675:Child, Preschool; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005100:Expectorants / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D007223:Infant; D007362:Intensive Care Units; D015278:Intensive Care Units, Pediatric; D008297:Male; D010100:Oxygen / Q000627:therapeutic use; D011446:Prospective Studies; D012121:Respiration, Artificial; D012128:Respiratory Distress Syndrome / Q000097:blood / Q000188:drug therapy*; D016896:Treatment Outcome
chemical_list: D005100:Expectorants; D000551:Ambroxol; D010100:Oxygen
keywords: acute respiratory distress syndrome; ambroxol; children; ventilator-free days in 14 days