Effects of Vasopressors on Immune Response

• Status: Completed
• Trial end date: 2016-10-01
• Target enrollment: 0
• Participant gender: Male

Summary

Noradrenaline is a catecholamine and the cornerstone treatment for the improvement of hemodynamic parameters in septic shock. Catecholamines exert profound immunomodulatory effects. Noradrenaline in vitro inhibits LPS-induced pro-inflammatory cytokine production, however, the actions on immune function in vivo have not been assessed. Furthermore, effects on the immune system of viable vasopressor alternatives for the treatment of septic patients, namely phenylephrine and vasopressin, need to be established in humans in vivo.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Radboud University
• Treatments: Arginine Vasopressin; Norepinephrine; Oxymetazoline; Phenylephrine; Vasoconstrictor Agents; Vasopressins

Criteria

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

• 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)

• Known anaphylaxis or hypersensitivity to the study drugs or their excipients

• Recent anaesthesia with halogenated agents

• Known cardiovascular disease (coronary artery disease)

• Known chronic nephritis