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

NCT03009643 | Unknown

• 1 other identifier: STiNO
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Nitric Oxide; Hypoxemia; Aortic Surgery

Keywords

Nitric Oxide; hypoxemia; aortic surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• ICU mortality

  From date of randomization until the date of death or discharge from ICU, up to 6 months.

• length of hospital stay (days)

  From date of randomization until the date of death or discharge from hospital, up to 6 months.

• length of ICU stay (days)

  From date of randomization until the date of death or discharge from ICU, up to 6 months.

• hospital mortality

  From date of randomization until the date of death or discharge from hospital, up to 6 months.

Study Arms (2)

iNO Group

EXPERIMENTAL

Patients are treated with iNO at a concentration of 5-10 ppm for 3-5 days according to the clinical conditions

Drug: Inhaled Nitric Oxide; Device: lung protective mechanical ventilation; Device: Hemodynamic monitoring

Control

OTHER

Patients are treated without iNO.

Device: lung protective mechanical ventilation; Device: Hemodynamic monitoring

Interventions

Inhaled Nitric Oxide DRUG

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

iNO Group

lung protective mechanical ventilation DEVICE

Mechanical ventilation in the SIMV mode (ventilators Evita 2 or 4,Dräger, Lübeck, Germany) with VT 6-8ml/kg

Control; iNO Group

Hemodynamic monitoring DEVICE

Flotrac/Vigileo (Edwards Lifesciences) are used to guide the fluid management.

Control; iNO Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients with refractory hypoxemia after aortic surgery;
• Accepting invasive mechanical ventilation;
• 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);
• The ventilator parameters: PEEP\>10cmH2O, VT 6-8ml/kg;
• The PaO2/FiO2 \<= 100mmHg.

You may not qualify if:

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

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Shanghai Zhongshan Hospital

Shanghai, 200032, China

RECRUITING

Related Publications (11)

• Garcia-Delgado M, Navarrete-Sanchez 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.

  PMID: 24514031 BACKGROUND

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

  PMID: 27168252 BACKGROUND

• Griffiths MJ, Evans TW. Inhaled nitric oxide therapy in adults. N Engl J Med. 2005 Dec 22;353(25):2683-95. doi: 10.1056/NEJMra051884. No abstract available.

  PMID: 16371634 BACKGROUND

• 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. doi: 10.1007/s00595-006-3226-5.

  PMID: 16865510 RESULT

• 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.

  PMID: 23631417 RESULT

• 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. doi: 10.1038/327524a0.

  PMID: 3495737 RESULT

• 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. doi: 10.1161/01.cir.83.6.2038.

  PMID: 2040056 RESULT

• 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. doi: 10.1097/00000542-199303000-00005.

  PMID: 8457043 RESULT

• 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.

  PMID: 26186889 RESULT

• 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;342(7):469-74. doi: 10.1056/NEJM200002173420704.

  PMID: 10675427 RESULT

• 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 Nov;104(5 Pt 1):1089-94. doi: 10.1542/peds.104.5.1089.

  PMID: 10545552 RESULT

Related Links

• Springer
• biomed central
• Nature Publishing Group
• NEJM
• NEJM

MeSH Terms

Conditions

Hypoxia

Interventions

Hemodynamic Monitoring

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Monitoring, Physiologic

Study Officials

• Zhe Luo, PhD

  Department of Critical Care Medicine

  STUDY DIRECTOR

Central Study Contacts

Guo-wei Tu, MD

CONTACT

+8613501996995; tu.guowei@zs-hospital.sh.cn

Guo-guang Ma, MD

CONTACT

+8615021519979; ma.guoguang@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending doctor, Department of cardiac surgery intensive care unit, Principal Investigator

Study Record Dates

• First Submitted: December 26, 2016
• First Posted: January 4, 2017
• Study Start: October 1, 2016
• Primary Completion: October 1, 2019
• Study Completion: December 1, 2019
• Last Updated: February 5, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)