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Trial record 15 of 32 for:    Interleukin-10

Evaluation of the Effectiveness of Non-invasive Ventilation on the Reperfusion Pulmonary Edema Post Pulmonary Artery Angioplasty in the Post Embolic Pulmonary Hypertension (OPR_VNI)

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ClinicalTrials.gov Identifier: NCT02548091
Recruitment Status : Unknown
Verified February 2017 by Centre Chirurgical Marie Lannelongue.
Recruitment status was:  Recruiting
First Posted : September 14, 2015
Last Update Posted : October 13, 2017
Sponsor:
Information provided by (Responsible Party):
Centre Chirurgical Marie Lannelongue

Brief Summary:
The purpose of this study is to determine whether Non Invasive Ventilation are effective in prevention of reperfusion pulmonary edema after pulmonary artery angioplasty. Our hypothesis is that administration of Non Invasive Ventilation during the procedure and systematically in post procedure period is a protective factor against the development and severity of reperfusion pulmonary edema.

Condition or disease Intervention/treatment Phase
Reperfusion Pulmonary Edema Other: Blood samples for assays of plasma inflammatory markers (cytokines InterLeukin-6, InterLeukin-8, InterLeukin-10) Procedure: Non invasive ventilation Procedure: monitoring system Pulse-Induced Contour Cardiac Output (Picco) Procedure: Computed tomography (CT) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 236 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Evaluation of the Effectiveness of Non-invasive Ventilation on the Reperfusion Pulmonary Oedema Post Pulmonary Artery Angioplasty in the Post Embolic Pulmonary Hypertension
Actual Study Start Date : February 1, 2016
Estimated Primary Completion Date : November 2017
Estimated Study Completion Date : March 2018

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Arm Intervention/treatment
Active Comparator: Preventive non invasive ventilation
Patients will receive the non invasive ventilation (NIV) systematically during the whole procedure of pulmonary angioplasty, and then systematically in post procedure period, 1 hour every 4 hours, during the whole hospitalization in post anesthesia care unit (PACU).
Other: Blood samples for assays of plasma inflammatory markers (cytokines InterLeukin-6, InterLeukin-8, InterLeukin-10)

The same amount of blood sample is collected from both arms of study at the same time of the procedure.

In each patient, in the per procedure period, a total of 50 milliliters of blood sample is drawn from the pulmonary circulation downstream and upstream of obstructive lesion, the trunk of pulmonary artery, the superior vena cava and the femoral arterial line prior to angioplasty and at the end of procedure; in the post interventional care unit 10 milliliters of blood sample will be draw daily from the superior vena cava catheter line and femoral arterial line.


Procedure: Non invasive ventilation
Procedure: monitoring system Pulse-Induced Contour Cardiac Output (Picco)
Procedure: Computed tomography (CT)
Non invasive ventilation on demand
Patients will not receive the NIV during the procedure of pulmonary angioplasty; in case of respiratory decompensation in post procedure period they will receive NIV during the whole hospitalization in PACU according to the following criteria: paradoxical breathing, respiratory rate above 25/minutes, a ratio of arterial oxygen pressure to fraction of inspired oxygen values (PaO2/FiO2) below 200.
Other: Blood samples for assays of plasma inflammatory markers (cytokines InterLeukin-6, InterLeukin-8, InterLeukin-10)

The same amount of blood sample is collected from both arms of study at the same time of the procedure.

In each patient, in the per procedure period, a total of 50 milliliters of blood sample is drawn from the pulmonary circulation downstream and upstream of obstructive lesion, the trunk of pulmonary artery, the superior vena cava and the femoral arterial line prior to angioplasty and at the end of procedure; in the post interventional care unit 10 milliliters of blood sample will be draw daily from the superior vena cava catheter line and femoral arterial line.


Procedure: Non invasive ventilation
Procedure: monitoring system Pulse-Induced Contour Cardiac Output (Picco)
Procedure: Computed tomography (CT)



Primary Outcome Measures :
  1. Lung Injury Score. [ Time Frame: Daily during hospitalization in the PACU on day 1 to 7. ]

Secondary Outcome Measures :
  1. Assays of plasma inflammatory markers (InterLeukin-6 , IInterLeukin-8, InterLeukin-10). [ Time Frame: 2 years ]
    The concentration will be given in pg/mL

  2. Extravascular Lung Water (EVLW) measures. [ Time Frame: 2 years ]
    EVLW is measure by thermodilution technique using a Pulse-Induced Contour Cardiac Output system (PICCO). The unit of EVLW is mL/Kg

  3. Computed tomography (CT) score [ Time Frame: 2 years ]
  4. Doppler pulsatility of the portal vein and its pulsatility ratio [ Time Frame: 2 years ]
  5. Pulmonary Vascular Index (PVI) measures [ Time Frame: 2 years ]
    PVI is measure by thermodilution technique using a Pulse-Induced Contour Cardiac Output system (PICCO



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Age ≥ 18 years
  • First and /or second procedure of pulmonary artery angioplasty
  • Mean pulmonary arterial pressure ≥ 40 mmHg and/or pulmonary vascular resistance ≥ 8 WU (Wood unit)
  • Patient who signed informed consent
  • Patients affiliated to a social security program

Exclusion criteria:

  • severe neurological disease: Coma Glasgow Scale < 8, severe cognitive decline, postural instability, loss of autonomy.
  • psychiatric disease (illness)
  • sepsis, severe sepsis and septic shock, according to definitions and diagnostic criteria for sepsis of 'Surviving Sepsis Campaign 2012'
  • severe respiratory failure defined by a total lung capacity (TLC)< 50% of the predicted value and/or expiratory volume in 1 second (FEV) < 30% of predicted value
  • obstructive sleep apnea syndrome with Continuous Positive Airway treatment
  • preexisting hemorrhagic syndrome or coagulation factors deficiency
  • severe renal insufficiency with glomerular filtration rate < 30 ml/min
  • severe hepatic failure with hepatic encephalopathy, hemodynamic disorder, decompensates cirrhosis, metabolic disorder( metabolic acidosis, hypoglycemia) hepatorenal syndrome, coagulation disorder (factor V< 50%,disseminated intravascular coagulation)
  • patient refusal of participation in the study program
  • subjects not affiliated to social security program

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02548091


Contacts
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Contact: PATRASCU ALINA, MD 01 40 94 25 97 a.patrascu@ccml.fr

Locations
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France
Centre Chirurgical Marie Lannelongue Recruiting
Le Plessis Robinson, France, 92350
Sponsors and Collaborators
Centre Chirurgical Marie Lannelongue

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Responsible Party: Centre Chirurgical Marie Lannelongue
ClinicalTrials.gov Identifier: NCT02548091     History of Changes
Other Study ID Numbers: 2015-A00399-40
First Posted: September 14, 2015    Key Record Dates
Last Update Posted: October 13, 2017
Last Verified: February 2017

Keywords provided by Centre Chirurgical Marie Lannelongue:
non invasive ventilation
reperfusion pulmonary edema
chronic thrombolic pulmonary hypertension
pulmonary artery angioplasty

Additional relevant MeSH terms:
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Hypertension
Edema
Hypertension, Pulmonary
Pulmonary Edema
Vascular Diseases
Cardiovascular Diseases
Signs and Symptoms
Lung Diseases
Respiratory Tract Diseases