A randomized, double-blind, placebo-controlled study of ascending single low doses of LPS administered intravenously to healthy volunteers to assess the dose-response relation.

A randomized, double-blind, placebo-controlled study of ascending single low doses of LPS administered intravenously to healthy volunteers to assess the dose-response relation. - LPS challenge in healthy volunteers.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON37142

Enrollment

Registered

2012-07-31

Start date

2012-08-20

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

inflammation

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: -Healthy male volunteers aged 18 to 40 years, inclusive, on study day 1; -Body Mass Index (BMI) in the range of 18 to 25 kg/m2; -No history of alcohol or elicit drug abuse; -No history of trauma and/or surgery to spleen; -Free from any clinically relevant febrile illness 30 days preceding study day 1; -No use of any prescription drugs, aspirin or other non-steroid anti-inflammatory drugs, either topical or systemic;

Exclusion criteria

Exclusion criteria: -Previous participation in a LPS challenge trial or prior exposure to endotoxin in an experimental setting within 4 weeks of the anticipate exposure; -Recent antibiotic use, operation or intervention by surgeon/dentist; -Any active inflammatory or infectious disease (e.g. periodontitis); -Hypertension (defined as systolic blood pressure RR > 160 mmHg or diastolic blood pressure RR > 90 mmHg, repeatedly measured after 5 minutes in resting supine position); -Hypotension (defined as systolic blood pressure RR 120 ms, PR interval > 200 ms, QTc interval > 430 ms).

Design outcomes

Primary

Measure	Time frame
-Relationship LPS dose - inflammatory response: Hs-CRP, cytokine panel (TNF-alpha among others, t.b.d.). -Relationship with other systemic responses: Coagulation: aPTT, PT. -Tolerance/paralysis of the immune system after in vivo LPS administration: TNF-alpha release after ex vivo whole blood LPS challenge. -Renal damage: KIM-1, NAG, alpha-GST, beta 2 microglobulin, creatinine.	—

Countries

Netherlands

Outcome results