Clinical trial NCT03009643: Salvage Treatment of Inhaled Nitric Oxide in Patients With Refractory Hypoxemia After Aortic Surgery
Official title: Salvage Treatment of Inhaled Nitric Oxide in Patients With Refractory Hypoxemia After Aortic Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Nitric Oxide
Hypoxemia
Aortic Surgery
Keywords: Nitric Oxide
hypoxemia
aortic surgery
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2017-01-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 description: 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.

Eligibility criteria: Inclusion Criteria:

1. Adult patients with refractory hypoxemia after aortic surgery;
2. Accepting invasive mechanical ventilation;
3. Chest X-ray and lung ultrasound to exclude the respiratory factors (eg. pulmonary edema, obstructive atelectasis, pleural effusion, pneumothorax) and hemodynamic factors (pericardial tamponade, acute pulmonary hypertension, intracardiac shunt);
4. The ventilator parameters: PEEP\>10cmH2O, VT 6-8ml/kg;
5. The PaO2/FiO2 \<= 100mmHg.

Exclusion Criteria:

1. Age \<18 years old;
2. Pregnant women;
3. Past medical history included COPD or mental illness;
4. The serious infection or sepsis patients;
5. Patients with pulmonary hypertension and right ventricular dysfunction

Primary outcomes:
measure: Mechanical ventilation time (days)
timeFrame: During whole ICU stay. From date of randomization until the date of death or discharge from ICU, up to 6 months.
Secondary outcomes:
measure: ICU mortality
timeFrame: From date of randomization until the date of death or discharge from ICU, up to 6 months.
measure: length of hospital stay (days)
timeFrame: From date of randomization until the date of death or discharge from hospital, up to 6 months.
measure: length of ICU stay (days)
timeFrame: From date of randomization until the date of death or discharge from ICU, up to 6 months.
measure: hospital mortality
timeFrame: From date of randomization until the date of death or discharge from hospital, up to 6 months.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Zhongshan Hospital
Study officials:
affiliation: Department of Critical Care Medicine
name: Zhe Luo, PhD
role: STUDY_DIRECTOR
References:
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