the influence of remote ischemic preconditioning on inflammation during human endotoxemia, a pilot proof-of-principle study

the influence of remote ischemic preconditioning on inflammation during human endotoxemia, a pilot proof-of-principle study - RISPENDO

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON42617

Enrollment

Registered

2015-10-21

Start date

2015-10-29

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

auto-immune diseases infectious diseases

Interventions

A blood-pressure cuff with handheld rubber inflation balloon and manometer is placed on the non-dominant arm of the subject. The cuff will be placed proximally from the elbow with the most proximal

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Age *18 and *35 yrs Male Healthy

Exclusion criteria

Exclusion criteria: Use of any medication Smoking Use of recreational drugs within 21 days prior to endotoxemia experiment day Use of caffeine or alcohol within 1 day prior to endotoxemia experiment day Previous participation in a trial where LPS was administered Surgery or trauma with significant blood loss or blood donation within 3 months prior to endotoxemia experiment day Participation in another clinical trial within 3 months prior to endotoxemia experiment day History, signs, or symptoms of cardiovascular disease History of frequent vaso-vagal collapse or of orthostatic hypotension History of atrial or ventricular arrhythmia Hypertension (RR systolic>160 or RR diastolic>90) Hypotension (RR systolic120 µmol/L Liver function abnormality: alkaline phosphatase>230 U/L and/or ALT>90 U/L History of asthma Obvious disease associated with immune deficiency CRP > 20 mg/L WBC> 12x109/L or clinically significant acute illness, including infections, within 4 weeks before endotoxemia day

Design outcomes

Primary

Measure	Time frame
The main study endpoint is the difference in circulating TNF-* over time following LPS administration between the multiple-dose RIPC group and the control group (see section 10 for details on the statistical comparisons).	—

Secondary

Measure	Time frame
Secondary study parameters/endpoints * Other circulating cytokines (including, but not limited to IL-6, IL-10 and IL-1RA) * Body temperature * Hemodynamic parameters (heart rate, blood pressure) * Leukocyte counts and differentiation * Plasma adenosine levels and expression of adenosine receptors and enzymes involved in adenosine metabolism in leukocytes * Presence of TLR ligands in plasma (HEK cells) * HSP70 levels in plasma * HIF-1* expression in leukocytes * Production of inflammatory mediators by ex vivo-stimulated leukocytes * Inflammatory transcriptional pathways (by use of qPCR/microarrays/RNA sequencing)	—

Measure

Time frame

Secondary study parameters/endpoints * Other circulating cytokines (including, but not limited to IL-6, IL-10 and IL-1RA) * Body temperature * Hemodynamic parameters (heart rate, blood pressure) * Leukocyte counts and differentiation * Plasma adenosine levels and expression of adenosine receptors and enzymes involved in adenosine metabolism in leukocytes * Presence of TLR ligands in plasma (HEK cells) * HSP70 levels in plasma * HIF-1* expression in leukocytes * Production of inflammatory mediators by ex vivo-stimulated leukocytes * Inflammatory transcriptional pathways (by use of qPCR/microarrays/RNA sequencing)

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)