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van CCT (UK)


The effects of cooling on the human inflammatory response


- candidate number27050
- NTR NumberNTR6367
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR6-apr-2017
- Secondary IDsNL53460.018.15 METC 2015_157
- Public TitleThe effects of cooling on the human inflammatory response
- Scientific TitleExternal Surface Cooling In huMan endOtoxemia
- ACRONYMESCIMO
- hypothesisWe hypothesize that cooling reduces endotoxemia induced inflammation and does not cause immunosuppression.
- Healt Condition(s) or Problem(s) studiedFever, Inflammation, endotoxemia
- Inclusion criteria1. Healthy male volunteer
2. Age 18 years <35 years
3. BMI between 20 and 25 kg/m2
- Exclusion criteria1. 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
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mei-2017
- planned closingdate1-sep-2017
- Target number of participants12
- InterventionsGroup 1: LPS + external cooling to 36C from T = 0 hours after LPS infusion
Group 2: LPS
- Primary outcomeHost 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 outcomeCoagulation 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.
- TimepointsT=0, T=1, T=3, T=6, T=8
- Trial web site
- status[default]
- CONTACT FOR PUBLIC QUERIES Matthew Harmon
- CONTACT for SCIENTIFIC QUERIES Matthew Harmon
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC)
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD6-apr-2017 - 19-jun-2017


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl