The effects of different vasopressors on the innate immune response during experimental human endotoxemia, a pilot proof-of-principle study

Completed

• Conditions: bacterial bloodstream infection; Sepsis; 10027665; 10004018

• Registration Number: NL-OMON42684
• Lead Sponsor: Radboud Universitair Medisch Centrum

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: 40

Inclusion Criteria

- Written informed consent;- Age >=18 and <=35 yrs;- Male;- Healthy

Exclusion Criteria

- Use of any medication;- Smoking;- Previous spontaneous vagal collapse;- History of atrial or ventricular arrhythmia;- (Family) history of myocardial infarction or stroke under the age of 65 years;- Cardiac conduction abnormalities on the ECG consisting of a 2nd degree atrioventricular block or a complex bundle branch block;- Hypertension (defined as RR systolic >160 or RR diastolic > 90);- Hypotension (defined as RR systolic < 100 or RR diastolic < 50);- Renal impairment (defined as plasma creatinin >120 µmol/l);- Liver enzyme abnormalities or positive hepatitis serology;- Medical history of any disease associated with immune deficiency;- CRP > 20 mg/L, WBC > 12x109/L, or clinically significant acute illness, including infections, within 4 weeks before endotoxin administration;- Participation in a drug trial or donation of blood 3 months prior to the LPS challenge;- Use of recreational drugs within 7 days prior to experiment day;- Recent hospital admission or surgery with general anaesthesia (<3 months)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Our primary objective is to investigate whether noradrenaline exerts<br /><br>immunomodulatory effects in humans in vivo during experimental human<br /><br>endotoxemia. This will be determined by comparing plasma levels of various pro-<br /><br>and anti-inflammatory cytokines between the group that receives noradrenaline<br /><br>infusion and the group that receives placebo (0.9% NaCl) infusion.</p><br>