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Hyperoxia, Erythropoiesis and Microcirculation in Critically Ill Patient

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02481843
First Posted: June 25, 2015
Last Update Posted: July 7, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Abele Donati, MD, Università Politecnica delle Marche
  Purpose
Prospective observational study in 40 adult critically ill patients. Patients were eligible if they were mechanically ventilated with an FiO2 ≤0.5 and PaO2/FiO2 ≥200 mmHg and hemodynamically stable with a hemoglobin ≥9 g/dL, no acute bleeding or need for blood transfusions, no renal failure, no chronic obstructive pulmonary disease. Twenty patients (hyperoxia group) underwent a 2-hour exposure to normobaric hyperoxia (FiO2 1.0), 20 patients were evaluated as controls. Serum erythropoietin (EPO) was measured at baseline, 24h and 48h. Serum Glutathione (GSH) and reacting oxygen species (ROS) were assessed at baseline (t0), after 2 hours of hyperoxia (t1) and 2 hours after the return to baseline FiO2 (t2). Sidestream dark field videomicroscopy was applied sublingually to assess the microvascular response to hyperoxia. Near infrared spectroscopy with a vascular occlusion test was applied at t0, t1, t2.

Condition Intervention Phase
Respiratory Failure Other: 2 hours of hyperoxia (FiO2 = 1) Phase 2

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Hyperoxia, Erythropoiesis and Tissue Oxygenation in Critically Ill Patient

Further study details as provided by Abele Donati, MD, Università Politecnica delle Marche:

Primary Outcome Measures:
  • Effectiveness of Normobaric Oxygen Hyperoxia in increasing serum erythropoietin levels in critically ill patients [ Time Frame: up to 2 day after FiO2=1 exposure ]
    Blood samples to detect erythropoietin


Secondary Outcome Measures:
  • Effects of hyperoxia on the sublingual microcirculation [ Time Frame: Before FiO2, after 2 hours of FiO2=1 exposure, 2 hours after the end of FiO2=1 exposure ]
    SDF technique will be used to look at sublingual microcirculation, 20 seconds movies are registered and software is used to analyze them

  • Effects of hyperoxia on the peripheral microcirculation [ Time Frame: Before FiO2 = 1, after 2 hours of FiO2=1 exposure, 2 hours after the end of FiO2=1 exposure ]
    Near Infra-Red Spectroscopy is used to assess oxygen tissue saturation at thenar and vascular occlusion test is performed to assess the desaturation and resaturation curves

  • Hyperoxia and variations in circulating glutathione [ Time Frame: Before FiO2 = 1, after 2 hours of FiO2=1 exposure, 2 hours after the end of FiO2=1 exposure ]
    Blood samples

  • Hyperoxia and variations in circulating nitric oxide [ Time Frame: Before FiO2 = 1, after 2 hours of FiO2=1 exposure, 2 hours after the end of FiO2=1 exposure ]
    Blood samples

  • Hyperoxia and variations in circulating ROS [ Time Frame: Before FiO2 = 1, after 2 hours of FiO2=1 exposure, 2 hours after the end of FiO2=1 exposure ]
    Blood samples

  • Reticulocyte Count [ Time Frame: Before FiO2 = 1, at 1 day and 2 day after FiO2=1 exposure ]
  • Effectiveness of Normobaric Oxygen Hyperoxia in increasing serum erythropoietin levels in critically ill patients after 1 day [ Time Frame: Before FIO2 = 1 and at 1 day after FiO2 = 1 exposure ]

Biospecimen Retention:   Samples Without DNA
Blood samples for plasma and serum

Enrollment: 40
Study Start Date: April 2013
Study Completion Date: March 2015
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Hyperoxia
2-hours of hyperoxia (FiO2 = 1.0)
Other: 2 hours of hyperoxia (FiO2 = 1)
Patients received 2 hours of hyperoxia at FiO2 = 1
Other Name: Hyperoxia
Control
2-hours control without hyperoxia

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult (≥18-year old) patients admitted to a 12-bed medical-surgical ICU
Criteria

Inclusion Criteria:

  • Mechanical Ventilated Patients

Exclusion Criteria:

  • PaO2/FiO2 < 200
  • hemoglobin (Hb) <9 g/dL
  • acute bleeding or blood transfusions during the study period
  • any surgical interventions during the study period
  • acute or chronic renal failure
  • hemodynamic instability
  • chronic obstructive pulmonary disease
  • pregnancy
  • factors impeding the sublingual microcirculation evaluation (oral surgery or facial trauma)
  Contacts and Locations
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): NCT02481843


Locations
Italy
University ICU, AOU Ospedali Riuniti Ancona
Torrette di Ancona, Ancona, Italy, 60126
Sponsors and Collaborators
Università Politecnica delle Marche
Investigators
Principal Investigator: Abele Donati, MD AOU Ospedali Riuniti Ancona
  More Information

Responsible Party: Abele Donati, MD, Associate Professor and Medical Doctor, Università Politecnica delle Marche
ClinicalTrials.gov Identifier: NCT02481843     History of Changes
Other Study ID Numbers: NOP001
First Submitted: June 15, 2015
First Posted: June 25, 2015
Last Update Posted: July 7, 2015
Last Verified: July 2015

Keywords provided by Abele Donati, MD, Università Politecnica delle Marche:
Hyperoxia
Microcirculation
Erythropoietin
Normobaric Oxygen Paradox

Additional relevant MeSH terms:
Critical Illness
Respiratory Insufficiency
Hyperoxia
Disease Attributes
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms