Clinical Trial: Salvage Treatment of Inhaled Nitric Oxide in Patients With Refractory Hypoxemia After Aortic Surgery

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Salvage Treatment of Inhaled Nitric Oxide in Patients With Refractory Hypoxemia After Aortic Surgery

Brief Summary: Hypoxemia is a common complication after aortic surgery. As this complication has an adverse effect on the postoperative course of the patient, early treatment is important; however, the mechanism of hypoxemia after surgery for acute aortic dissection remains unclear. Recently, the investigators found that inhaled Nitric Oxide can improve the oxygenation in some of these patients. The investigators are trying to evaluate the effectiveness and safety of inhaled Nitric Oxide in patients with refractory hypoxemia after aortic surgery.

Detailed Summary:

Several risk factors for severe hypoxemia after aortic surgery have been reported including advanced age, obesity, smoking history, previous heart surgery,emergency surgery,reduced cardiac function, advanced chronic obstructive pulmonary disease, excessive volume of blood transfusion,and prolonged CPB time. The routine treatment includes lung protective mechanical ventilation, recruitment maneuvers and glucocorticoids.

No previous clinical studies have reported the effectiveness and safety of inhaled Nitric Oxide in patients with refractory hypoxemia after aortic surgery.


Sponsor: Shanghai Zhongshan Hospital

Current Primary Outcome: Mechanical ventilation time (days) [ Time Frame: During whole ICU stay. From date of randomization until the date of death or discharge from ICU, up to 6 months. ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • ICU mortality [ Time Frame: From date of randomization until the date of death or discharge from ICU, up to 6 months. ]
  • length of hospital stay (days) [ Time Frame: From date of randomization until the date of death or discharge from hospital, up to 6 months. ]
  • length of ICU stay (days) [ Time Frame: From date of randomization until the date of death or discharge from ICU, up to 6 months. ]
  • hospital mortality [ Time Frame: From date of randomization until the date of death or discharge from hospital, up to 6 months. ]


Original Secondary Outcome: Same as current

Information By: Shanghai Zhongshan Hospital

Dates:
Date Received: December 26, 2016
Date Started: October 2016
Date Completion: December 2019
Last Updated: January 3, 2017
Last Verified: December 2016