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

Completed

• Conditions: auto-immune diseases; infectious diseases; 10003816; 10002252

• Registration Number: NL-OMON42617
• Lead Sponsor: Intensive Care

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

Age *18 and *35 yrs
Male
Healthy

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 systolic<100 or RR diastolic<50)
Conduction abnormalities on the ECG consisting of a 1st degree atrioventricular block or a complex bundle branch block
Renal impairment: plasma creatinine>120 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study endpoint is the difference in circulating TNF-* over time<br /><br>following LPS administration between the multiple-dose RIPC group and the<br /><br>control group (see section 10 for details on the statistical comparisons).</p><br>

Secondary Outcome Measures

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