Hyperoxia, Erythropoiesis and Microcirculation in Critically Ill Patient

NCT02481843 | Completed

• 1 other identifier: NOP001
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Respiratory Failure

Keywords

Hyperoxia; Microcirculation; Erythropoietin; Normobaric Oxygen Paradox

Outcome Measures

Primary Outcomes (1)

• Effectiveness of Normobaric Oxygen Hyperoxia in increasing serum erythropoietin levels in critically ill patients

  Blood samples to detect erythropoietin

  up to 2 day after FiO2=1 exposure

Secondary Outcomes (7)

• Effects of hyperoxia on the sublingual microcirculation

  Before FiO2, after 2 hours of FiO2=1 exposure, 2 hours after the end of FiO2=1 exposure

• Effects of hyperoxia on the peripheral microcirculation

  Before FiO2 = 1, after 2 hours of FiO2=1 exposure, 2 hours after the end of FiO2=1 exposure

• Hyperoxia and variations in circulating glutathione

  Before FiO2 = 1, after 2 hours of FiO2=1 exposure, 2 hours after the end of FiO2=1 exposure

• Hyperoxia and variations in circulating nitric oxide

  Before FiO2 = 1, after 2 hours of FiO2=1 exposure, 2 hours after the end of FiO2=1 exposure

• Hyperoxia and variations in circulating ROS

  Before FiO2 = 1, after 2 hours of FiO2=1 exposure, 2 hours after the end of FiO2=1 exposure

Study Arms (2)

Hyperoxia

2-hours of hyperoxia (FiO2 = 1.0)

Other: 2 hours of hyperoxia (FiO2 = 1)

Control

2-hours control without hyperoxia

Interventions

2 hours of hyperoxia (FiO2 = 1) OTHER

Patients received 2 hours of hyperoxia at FiO2 = 1

Also known as: Hyperoxia

Hyperoxia

Eligibility Criteria

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

Study Population

Adult (≥18-year old) patients admitted to a 12-bed medical-surgical ICU

You may qualify if:

• Mechanical Ventilated Patients

You may not qualify if:

• 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)

Sponsors & Collaborators

• Università Politecnica delle Marche: lead

Study Sites (1)

University ICU, AOU Ospedali Riuniti Ancona

Torrette Di Ancona, Ancona, 60126, Italy

Location

Related Publications (1)

• Donati A, Damiani E, Zuccari S, Domizi R, Scorcella C, Girardis M, Giulietti A, Vignini A, Adrario E, Romano R, Mazzanti L, Pelaia P, Singer M. Effects of short-term hyperoxia on erythropoietin levels and microcirculation in critically Ill patients: a prospective observational pilot study. BMC Anesthesiol. 2017 Mar 23;17(1):49. doi: 10.1186/s12871-017-0342-2.

  PMID: 28335733 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples for plasma and serum

MeSH Terms

Conditions

Respiratory Insufficiency; Hyperoxia

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Abele Donati, MD

  AOU Ospedali Riuniti Ancona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor and Medical Doctor

Study Record Dates

• First Submitted: June 15, 2015
• First Posted: June 25, 2015
• Study Start: April 1, 2013
• Primary Completion: January 1, 2015
• Study Completion: March 1, 2015
• Last Updated: July 7, 2015

Record last verified: 2015-07

Locations

IT (1)