No registrations found.
ID
Source
Brief title
Health condition
Cooling, fever control, endotoxemia, inflammation, healthy volunteers
Sponsors and support
Intervention
Outcome measures
Primary outcome
Host immune response: Il-6 (primary outcome), but also Full blood count, leukocyte differentiation, C-reactive protein (CRP)
Other pro- and anti-inflammatory cytokines by enzyme-linked immunosorbent assay (ELISA), markers of endothelial condition (von willebrand factor(vWF), syndecan-1, thrombomodulin by ELISA. Expression of granulocyte activation and adhesion molecules by flow cytometry. HLA-DR expression will aslo be measured with flow cytometry. Urine levels of catecholamines will be measured using ELISA. Whole blood ex-vivo stimulation with LPS and LTA
Secondary outcome
Coagulation processes: Activated partial thromboplastin time (APTT), (partial thromboplastin time) PTT, D-Dimer, rotational thromboelastometry (ROTEM).
By ELISA: F1+2, thrombin generation, tissue factor, tissue factor pathway inhibitor, protein-C levels, antithrombin, Proteinase-activated receptor(PAR)-1, plasminogen activator inhibitor(PAI)-1.
Tissue perfusion and oxygenation: Nexfin will be used to measure cardiac output.
SDF will be used to visualize and examine the microcirculation in real time.
NIRS will be used to assess tissue oxygenation.
Study objective
We hypothesize that cooling reduces endotoxemia induced inflammation and does not cause immunosuppression.
Study design
T=0, T=1, T=3, T=6, T=8
Intervention
Group 1: LPS + external cooling to 36¡ãC from T = 0 hours after LPS infusion
Group 2: LPS
Matthew
Harmon
Meibergdreef 9,
1105AZ
+31205668222
Matthew
Harmon
Meibergdreef 9,
1105AZ
+31205668222
Inclusion criteria
1. Healthy male volunteer
2. Age ¡Ý 18 years <35 years
3. BMI between 20 and 25 kg/m2
Exclusion criteria
1. No informed consent
2. Any abnormal test result during the screening prior to inclusion of the study (medical history, physical examination, ECG, blood examination).
3. History of drug abuse
4. Any present medication use on prescription
5. Participation in any other medical drug study < 3 months
6. Participation in previous volunteer studies using LPS
7. History of an allergic reaction to opiates
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL6203 |
| NTR-old | NTR6367 |
| CCMO | NL53460.018.15 |
| OMON | NL-OMON45163 |