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

Hypoxemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03009643
• Other study ID #: STiNO
• Status: Recruiting
• Phase: N/A
• First received: December 26, 2016
• Last updated: February 1, 2018
• Start date: October 2016
• Est. completion date: December 2019

Study information

• Verified date: February 2018
• Source: Shanghai Zhongshan Hospital
• Contact: Guo-wei Tu, MD
• Phone: +8613501996995
• Email: tu.guowei[@]zs-hospital.sh.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2019
• Est. primary completion date: October 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Surgery
• Hypoxemia
• Hypoxia
• Nitric Oxide

Intervention

Drug:
• Inhaled Nitric Oxide
Patients are treated with iNO for 3-5 days.The concentration of inhaled Nitric Oxide is around 5-10ppm.

Device:
• lung protective mechanical ventilation
Mechanical ventilation in the SIMV mode (ventilators Evita 2 or 4,Dräger, Lübeck, Germany) with VT 6-8ml/kg
• Hemodynamic monitoring
Flotrac/Vigileo (Edwards Lifesciences) are used to guide the fluid management.

Locations

Country	Name	City	State
China	Shanghai Zhongshan Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

References & Publications (11)

Ball L, Battaglini D, Pelosi P. Postoperative respiratory disorders. Curr Opin Crit Care. 2016 Aug;22(4):379-85. doi: 10.1097/MCC.0000000000000312. — View Citation

Benedetto M, Romano R, Baca G, Sarridou D, Fischer A, Simon A, Marczin N. Inhaled nitric oxide in cardiac surgery: Evidence or tradition? Nitric Oxide. 2015 Sep 15;49:67-79. doi: 10.1016/j.niox.2015.06.002. Epub 2015 Jul 14. Review. — View Citation

Clark RH, Kueser TJ, Walker MW, Southgate WM, Huckaby JL, Perez JA, Roy BJ, Keszler M, Kinsella JP. Low-dose nitric oxide therapy for persistent pulmonary hypertension of the newborn. Clinical Inhaled Nitric Oxide Research Group. N Engl J Med. 2000 Feb 17 — View Citation

Cornfield DN, Maynard RC, deRegnier RA, Guiang SF 3rd, Barbato JE, Milla CE. Randomized, controlled trial of low-dose inhaled nitric oxide in the treatment of term and near-term infants with respiratory failure and pulmonary hypertension. Pediatrics. 1999 — View Citation

Frostell C, Fratacci MD, Wain JC, Jones R, Zapol WM. Inhaled nitric oxide. A selective pulmonary vasodilator reversing hypoxic pulmonary vasoconstriction. Circulation. 1991 Jun;83(6):2038-47. Erratum in: Circulation 1991 Nov;84(5):2212. — View Citation

Frostell CG, Blomqvist H, Hedenstierna G, Lundberg J, Zapol WM. Inhaled nitric oxide selectively reverses human hypoxic pulmonary vasoconstriction without causing systemic vasodilation. Anesthesiology. 1993 Mar;78(3):427-35. — View Citation

García-Delgado M, Navarrete-Sánchez I, Colmenero M. Preventing and managing perioperative pulmonary complications following cardiac surgery. Curr Opin Anaesthesiol. 2014 Apr;27(2):146-52. doi: 10.1097/ACO.0000000000000059. Review. — View Citation

Griffiths MJ, Evans TW. Inhaled nitric oxide therapy in adults. N Engl J Med. 2005 Dec 22;353(25):2683-95. Review. — View Citation

Nakajima T, Kawazoe K, Izumoto H, Kataoka T, Niinuma H, Shirahashi N. Risk factors for hypoxemia after surgery for acute type A aortic dissection. Surg Today. 2006;36(8):680-5. — View Citation

Palmer RM, Ferrige AG, Moncada S. Nitric oxide release accounts for the biological activity of endothelium-derived relaxing factor. Nature. 1987 Jun 11-17;327(6122):524-6. — View Citation

Wang Y, Xue S, Zhu H. Risk factors for postoperative hypoxemia in patients undergoing Stanford A aortic dissection surgery. J Cardiothorac Surg. 2013 Apr 30;8:118. doi: 10.1186/1749-8090-8-118. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mechanical ventilation time (days)		During whole ICU stay. From date of randomization until the date of death or discharge from ICU, up to 6 months.
Secondary	ICU mortality		From date of randomization until the date of death or discharge from ICU, up to 6 months.
Secondary	length of hospital stay (days)		From date of randomization until the date of death or discharge from hospital, up to 6 months.
Secondary	length of ICU stay (days)		From date of randomization until the date of death or discharge from ICU, up to 6 months.
Secondary	hospital mortality		From date of randomization until the date of death or discharge from hospital, up to 6 months.

External Links

•   biomed central
•   Elsevier Science
•   HighWire
•   Lippincott Williams & Wilkins
•   Lippincott Williams & Wilkins, Inc
•   Nature Publishing Group
•   NEJM
•   NEJM
•   Pediatrics
•   Springer