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

February 1, 2018 updated by: Guowei Tu, Shanghai Zhongshan Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China, 200032
        • Recruiting
        • Shanghai Zhongshan Hospital
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Guang-wei Hao, MD
        • Sub-Investigator:
          • Guo-guang Ma, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: iNO Group
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
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
Device: Hemodynamic monitoring
Flotrac/Vigileo (Edwards Lifesciences) are used to guide the fluid management.
Other: Control
Patients are treated without iNO.
Device: lung protective mechanical ventilation
Mechanical ventilation in the SIMV mode (ventilators Evita 2 or 4,Dräger, Lübeck, Germany) with VT 6-8ml/kg
Device: Hemodynamic monitoring
Flotrac/Vigileo (Edwards Lifesciences) are used to guide the fluid management.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
During whole ICU stay. From date of randomization until the date of death or discharge from ICU, up to 6 months.

Secondary Outcome Measures

Outcome Measure
Time Frame
ICU mortality
Time Frame: From date of randomization until the date of death or discharge from ICU, up to 6 months.
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.
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.
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.
From date of randomization until the date of death or discharge from hospital, up to 6 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Zhongshan Hospital

Investigators

  • Study Director: Zhe Luo, PhD, Department of Critical Care Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (Anticipated)

October 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

December 26, 2016

First Submitted That Met QC Criteria

January 3, 2017

First Posted (Estimate)

January 4, 2017

Study Record Updates

Last Update Posted (Actual)

February 5, 2018

Last Update Submitted That Met QC Criteria

February 1, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STiNO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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