Inflammatory status Other
Conditions
Interventions
After giving written informed consent eligible subjects were hospitalized at the clinical site on day 0 and fed with 3 meals and water to control dietary nitrate intake until the following morning (da
Sponsors
Medical University of Vienna
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Healthy male volunteers aged 18-45 years
Exclusion criteria
Exclusion criteria: Does not meet inclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Interleukin (IL)-6 is measured using high sensitivity enzyme immunoassays at baseline, 1 hour before LPS infusion, 2, 3, 4, 5, 7 hours after LPS infusion, day 2, and day 8 2. Interleukin (IL)-8 is measured using high sensitivity enzyme immunoassays at baseline, 1 hour before LPS infusion, 2, 3, 4, 5, 7 hours after LPS infusion, day 2, and day 8 3. Monocyte chemoattractant protein-1 (MCP-1) is measured using enzyme-immunoassay at baseline, 1 hour before LPS infusion, 2, 3, 4, 5, 7 hours after LPS infusion, day 2, and day 8 4. Tumor necrosis factor-alpha (TNF-alpha) is measured using high sensitivity enzyme immunoassays at baseline, 1 hour before LPS infusion, 2, 3, 4, 5, 7 hours after LPS infusion, day 2, and day 8 5. Soluble vascular cell adhesion protein-1 (VCAM-1) is measured using high sensitivity enzyme immunoassays at baseline, 1 hour before LPS infusion, 2, 3, 4, 5, 7 hours after LPS infusion, day 2, and day 8 6. Soluble E-selectin is measured using high sensitivity enzyme immunoassays at baseline, 1 hour before LPS infusion, 2, 3, 4, 5, 7 hours after LPS infusion, day 2, and day 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Matrix metalloproteinase-2 (MMP-2) is measured using enzyme immune assays (R&D Systems) at baseline, 1 hour before LPS infusion, 2, 3, 4, 5, 7 hours after LPS infusion, day 2, and day 8 2. Matrix metalloproteinase-9 (MMP-9) is measured using enzyme immune assays (R&D Systems) at baseline, 1 hour before LPS infusion, 2, 3, 4, 5, 7 hours after LPS infusion, day 2, and day 8 3. White blood counts (WBC) are measured using a cell counter (Sysmex, Milton Keynes, UK) at baseline, 1 hour before LPS infusion, 2, 3, 4, 5, 7 hours after LPS infusion, day 2, and day 8 4. Elastase is measured at baseline, 1 hour before LPS infusion, 2, 3, 4, 5, 7 hours after LPS infusion, day 2, and day 8 5. Von Willebrand Factor (VWF) is measured using turbidometry with a commercial kit from Behring (Marburg, Germany) at baseline, 1 hour before LPS infusion, 2, 3, 4, 5, 7 hours after LPS infusion, day 2, and day 8 6. Platelet counts are measured using a cell counter (Sysmex, Milton Keynes, UK) at baseline, 1 hour before LPS infusion, 2, 3, 4, 5, and 7 hours after LPS infusion, day 2, and day 8 7. ECG is measured every 15 minutes during the first 6 hours after endotoxin bolus infusion 8. Heart rate is measured every 15 minutes during the first 6 hours after endotoxin bolus infusion 9. Oxygen saturation is measured every 15 minutes during the first 6 hours after endotoxin bolus infusion 10. Lying blood pressure is measured every 15 minutes during the first 6 hours after endotoxin bolus infusion 11. Routine blood analysis is measured one week after endotoxin bolus infusion (day 8) 12. Occurrence of adverse events is monitored throughout the entire study period, including day 2 and day 8 follow-up visits | — |
Countries
Austria
Contacts
Public ContactSophie Brunner
Outcome results
None listed