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

Primary Purpose

Nitric Oxide, Hypoxemia, Aortic Surgery

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Inhaled Nitric Oxide
lung protective mechanical ventilation
Hemodynamic monitoring
Sponsored by
Shanghai Zhongshan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nitric Oxide focused on measuring Nitric Oxide, hypoxemia, aortic surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Shanghai Zhongshan HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

iNO Group

Control

Arm Description

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

Patients are treated without iNO.

Outcomes

Primary Outcome Measures

Mechanical ventilation time (days)

Secondary Outcome Measures

ICU mortality
length of hospital stay (days)
length of ICU stay (days)
hospital mortality

Full Information

First Posted
December 26, 2016
Last Updated
February 1, 2018
Sponsor
Shanghai Zhongshan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03009643
Brief Title
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

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 2016 (undefined)
Primary Completion Date
October 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Zhongshan Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nitric Oxide, Hypoxemia, Aortic Surgery
Keywords
Nitric Oxide, hypoxemia, aortic surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
iNO Group
Arm Type
Experimental
Arm Description
Patients are treated with iNO at a concentration of 5-10 ppm for 3-5 days according to the clinical conditions
Arm Title
Control
Arm Type
Other
Arm Description
Patients are treated without iNO.
Intervention Type
Drug
Intervention Name(s)
Inhaled Nitric Oxide
Intervention Description
Patients are treated with iNO for 3-5 days.The concentration of inhaled Nitric Oxide is around 5-10ppm.
Intervention Type
Device
Intervention Name(s)
lung protective mechanical ventilation
Intervention Description
Mechanical ventilation in the SIMV mode (ventilators Evita 2 or 4,Dräger, Lübeck, Germany) with VT 6-8ml/kg
Intervention Type
Device
Intervention Name(s)
Hemodynamic monitoring
Intervention Description
Flotrac/Vigileo (Edwards Lifesciences) are used to guide the fluid management.
Primary Outcome Measure Information:
Title
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.
Secondary Outcome Measure Information:
Title
ICU mortality
Time Frame
From date of randomization until the date of death or discharge from ICU, up to 6 months.
Title
length of hospital stay (days)
Time Frame
From date of randomization until the date of death or discharge from hospital, up to 6 months.
Title
length of ICU stay (days)
Time Frame
From date of randomization until the date of death or discharge from ICU, up to 6 months.
Title
hospital mortality
Time Frame
From date of randomization until the date of death or discharge from hospital, up to 6 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guo-wei Tu, MD
Phone
+8613501996995
Email
tu.guowei@zs-hospital.sh.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Guo-guang Ma, MD
Phone
+8615021519979
Email
ma.guoguang@zs-hospital.sh.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhe Luo, PhD
Organizational Affiliation
Department of Critical Care Medicine
Official's Role
Study Director
Facility Information:
Facility Name
Shanghai Zhongshan Hospital
City
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guo-wei Tu, MD
Phone
+8613501996995
Email
tu.guowei@zs-hospital.sh.cn
First Name & Middle Initial & Last Name & Degree
Zhe Luo, PhD
Phone
+13916127028
Email
luo.zhe@zs-hospital.sh.cn
First Name & Middle Initial & Last Name & Degree
Guang-wei Hao, MD
First Name & Middle Initial & Last Name & Degree
Guo-guang Ma, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24514031
Citation
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.
Results Reference
background
PubMed Identifier
27168252
Citation
Ball L, Battaglini D, Pelosi P. Postoperative respiratory disorders. Curr Opin Crit Care. 2016 Aug;22(4):379-85. doi: 10.1097/MCC.0000000000000312.
Results Reference
background
PubMed Identifier
16371634
Citation
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.
Results Reference
background
PubMed Identifier
16865510
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. doi: 10.1007/s00595-006-3226-5.
Results Reference
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PubMed Identifier
23631417
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.
Results Reference
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PubMed Identifier
3495737
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. doi: 10.1038/327524a0.
Results Reference
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PubMed Identifier
2040056
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. doi: 10.1161/01.cir.83.6.2038. Erratum In: Circulation 1991 Nov;84(5):2212.
Results Reference
result
PubMed Identifier
8457043
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. doi: 10.1097/00000542-199303000-00005.
Results Reference
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PubMed Identifier
26186889
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.
Results Reference
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PubMed Identifier
10675427
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;342(7):469-74. doi: 10.1056/NEJM200002173420704.
Results Reference
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PubMed Identifier
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Citation
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Results Reference
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Links:
URL
http://link.springer.com/article/10.1007%2Fs00595-006-3226-5
Description
Springer
URL
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3649943/
Description
biomed central
URL
http://www.nature.com/nature/journal/v327/n6122/abs/327524a0.html
Description
Nature Publishing Group

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

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