An interventional study of Aspirin and Placebo in Endotoxemia, sponsored by Radboud University Medical Center. Completed at 1 site in Netherlands. Open to male participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-07-31.
Sponsored by Radboud University Medical Center · Not applicable, Interventional, and Basic science
Rationale:
The last years, research focus has moved to immunostimulatory agents in order to restore or increase the functionality of the immune system during sepsis-induced immunoparalysis. Epidemiologic data show that prehospital use of low dose acetylsalicylic acid (ASA) is associated with improved outcome of sepsis. Experimental data indicate that ASA exerts pro-inflammatory effects during systemic inflammation. However, it remains to be determined whether treatment with ASA improves immune function once immunoparalysis has developed and whether prehospital use of low dose ASA prevents the development of immunoparalysis. In the former case, ASA is a potential immunostimulatory therapy that can treat sepsis-induced immunoparalysis. In the latter case, ASA may have a broader indication as an immunomodulating agent. Taken together, ASA might be a promising, cheap, well-known, and globally available agent to reduce the incidence of secondary infections and improve patient outcome in sepsis.
Objective:
Study design:
Double-blind randomized placebo-controlled pilot study in 30 healthy male volunteers during repeated experimental endotoxemia. All subjects will receive a 14 day course of study medication (low-dose ASA or placebo) and undergo experimental endotoxemia (lipopolysacharide (LPS), E.Coli type O113) on day 7 and on day 14. LPS is administrated using an initial bolus of 1ng/kg followed by continuous infusion at 1ng/kg/hr during 3 hours.
Subjects are randomized in three study arms:
81 studies on the registry are indexed under Endotoxemia; 7 are open to participants now.
This study's planned enrollment of 30 is close to the median of 31 across 70 interventional studies indexed under Endotoxemia.
Browse Endotoxemia studies →Radboud University Medical Center is the lead sponsor of 986 studies on the registry; 136 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
7 day treatment with placebo - first LPS challenge - 7 day treatment with ASA 80 mg (with a loading dose of 160 mg on the first day) - second LPS challenge
Drug: Aspirin · Drug: Placebo
7 day treatment with ASA 80 mg (with a loading dose of 160 mg on the first day) - first LPS challenge - 7 day treatment with ASA (no loading dose on first day) - second LPS challenge
Drug: Aspirin
7 day treatment with placebo - first LPS challenge - 7 day treatment with placebo - second LPS challenge
Drug: Placebo
Also known as: Acetylsalicylic acid, ASA
Change in concentration plasma TNFalpha (pg/ml)
measured with Luminex assay
Time frame: Measured after the first and second LPS-challenge (on day 7 and day 14)
Change in concentration plasma IL-6 (pg/ml)
measured with Luminex assay
Time frame: Measured after the first and second LPS-challenge (on day 7 and day 14)
Change in concentration plasma IL-8 (pg/ml)
measured with Luminex assay
Time frame: Measured after the first and second LPS-challenge (on day 7 and day 14)
Change in plasma concentration of IL-10 (pg/ml)
measured with Luminex assay
Time frame: Measured after the first and second LPS-challenge (on day 7 and day 14)
Change in plasma concentration of IL-1RA (pg/ml)
measured with Luminex assay
Time frame: Measured after the first and second LPS-challenge (on day 7 and day 14)
Change in plasma concentration of IL-1beta (pg/ml)
measured with Luminex assay
Time frame: Measured after the first and second LPS-challenge (on day 7 and day 14)
Change in plasma concentration of MCP-1 (pg/ml)
measured with Luminex assay
Time frame: Measured after the first and second LPS-challenge
Change in plasma concentration of MIP-1alpha (pg/ml)
measured with Luminex assay
Time frame: Measured after the first and second LPS-challenge (on day 7 and day 14)
Change in plasma concentration of MIP-1beta (pg/ml)
measured with Luminex assay
Time frame: Measured after the first and second LPS-challenge (on day 7 and day 14)
Change in monocytic HLA-DR expression (mHLA-DR)
Time frame: Measured after the first and second LPS-challenge (on day 7 and day 14)
Change in symptoms during endotoxin day
Time frame: Measured after the first and second LPS-challenge (on day 7 and day 14)
Change in blood pressure
Time frame: Measured after the first and second LPS-challenge (on day 7 and day 14)
Change in temperature
Time frame: Measured after the first and second LPS-challenge (on day 7 and day 14)
Change in heart rate
Time frame: Measured after the first and second LPS-challenge (on day 7 and day 14)
Change in cerebral blood flow using Transcranial Doppler (TCD) measurements and Near Infrared Spectroscopy (NIRS)
Time frame: Measured after the first and second LPS-challenge (on day 7 and day 14)
Arterial bloodgas
Time frame: Measured after the first and second LPS-challenge (on day 7 and day 14)
Change in platelet monocyte complexes
Time frame: Measured after the first and second LPS-challenge (on day 7 and day 14)
Change in monocyte surface antigen expression of PD-L1
Time frame: Measured after the first and second LPS-challenge (on day 7 and day 14)
Thromboxane B2
Time frame: Measured after the first and second LPS-challenge (on day 7 and day 14)
Prostaglandin E2 (PGE-M)
Time frame: Measured after the first and second LPS-challenge (on day 7 and day 14)
Change in plasma enkephalin
Time frame: Measured after the first and second LPS-challenge (on day 7 and day 14)
Kidney damage markers in urine (NGAL, KIM-1 and L-FABP)
Time frame: Measured after the first and second LPS-challenge (on day 7 and day 14)
Change in leukocyte count (and differentiation)
Time frame: Measured after the first and second LPS-challenge (on day 7 and day 14)
Change in transcriptional activity of leukocytes
Time frame: Measured after the first and second LPS-challenge (on day 7 and day 14)
Change in plasma concentration of IFN-gamma (pg/ml)
measured with Luminex assay
Time frame: Measured after the first and second LPS-challenge (on day 7 and day 14)
Change in lymphocyte surface antigen expression of PD-1 and IL7-RA
Time frame: Measured after the first and second LPS-challenge (on day 7 and day 14)
Plan to share: Undecided
This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Aspirin
Radboud University Medical Center →