title: Comparison of inhaled nitric oxide with aerosolized iloprost for treatment of pulmonary hypertension in children after cardiopulmonary bypass surgery.
abstract: OBJECTIVE
  Pilot study to compare the effect of inhaled nitric oxide (iNO) and aerosolized iloprost in preventing perioperative pulmonary hypertensive crises (PHTCs).
  
  
  BACKGROUND
  Guidelines recommend the use of iNO to treat PHTCs, but treatment with iNO is not an ideal vasodilator. Aerosolized iloprost may be a possible alternative to iNO in this setting.
  
  
  METHODS
  Investigator-initiated, open-label, randomized clinical trial in 15 infants (age range 77-257 days) with left-to-right shunt (11 out of 15 with additional trisomy 21), and pulmonary hypertension (i.e. mean pulmonary artery pressure [PAP] >25 mmHg) after weaning from cardiopulmonary bypass. Patients were randomized to treatment with iNO at 10 ppm or aerosolized iloprost at 0.5 µg/kg (every 2 h). The observation period was 72 h after weaning from cardiopulmonary bypass. The primary endpoint was the occurrence of PHTCs; the secondary endpoints were mean PAP, duration of mechanical ventilation, safety of administration, and in-hospital mortality.
  
  
  RESULTS
  Seven patients received iNO and eight patients received iloprost. During the observation period, 13 of the 15 patients had at least one major or minor PHTC. There was no difference between the groups with regard to the frequency of PHTCs, mean PAP and duration of mechanical ventilation (p > 0.05).
  
  
  CONCLUSIONS
  In this pilot study, aerosolized iloprost had a favorable safety profile. Larger trials are needed to compare its efficacy to iNO for the treatment of perioperative pulmonary hypertension. However, neither treatment alone abolished the occurrence of PHTCs.
authors.affiliation: Department of Cardiac Surgery, University of Heidelberg Medical Centre, INF 110, 69120, Heidelberg, Germany. tsvetomir.loukanov@med.uni-heidelberg.de
authors.forename: Tsvetomir
authors.initials: T
authors.lastname: Loukanov
authors.forename: Dietrich
authors.initials: D
authors.lastname: Bucsenez
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Springer
authors.forename: Christian
authors.initials: C
authors.lastname: Sebening
authors.forename: Helmut
authors.initials: H
authors.lastname: Rauch
authors.forename: Eva
authors.initials: E
authors.lastname: Roesch
authors.forename: Matthias
authors.initials: M
authors.lastname: Karck
authors.forename: Matthias
authors.initials: M
authors.lastname: Gorenflo
mesh_terms: D000280:Administration, Inhalation; D001993:Bronchodilator Agents / Q000627:therapeutic use; D002315:Cardiopulmonary Bypass / Q000009:adverse effects*; D006331:Heart Diseases / Q000151:congenital / Q000601:surgery*; D006801:Humans; D006976:Hypertension, Pulmonary / Q000209:etiology / Q000517:prevention & control*; D016285:Iloprost / Q000627:therapeutic use*; D007223:Infant; D009569:Nitric Oxide / Q000627:therapeutic use*; D010865:Pilot Projects; D011183:Postoperative Complications; D016896:Treatment Outcome; D014665:Vasodilator Agents / Q000627:therapeutic use
chemical_list: D001993:Bronchodilator Agents; D014665:Vasodilator Agents; D009569:Nitric Oxide; D016285:Iloprost