The effects of different vasopressors on inflammation.

Phase 1

• Conditions: Possible future indications: infectious diseases which require vasopressor therapy.; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2015-002706-36-NL
• Lead Sponsor: Radboudumc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-10-28
• Last Update Posted: 30 November 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 40

Inclusion Criteria

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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 clinical trial of medicinal product
• Study Design: Not specified