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The effects of concentration/meditation on the innate immune response during human endotoxemia

The effects of concentration/meditation on the innate immune response during human endotoxemia - LPS-concentration/meditation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON36635
Enrollment
1
Registered
2010-07-15
Start date
2011-03-09
Completion date
Unknown
Last updated
2024-05-06

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

Conditions

blood poisoning/sepsis

Interventions

The day of the experiment, prehydration will be performed by infusion of 1.5 L 2.5% glucose/0.45% saline solution in 1 hour before LPS administration. LPS derived from E coli O:113 will be injected

Sponsors

Universitair Medisch Centrum Sint Radboud
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: One male volunteer who masters the concentration/meditation technique.

Exclusion criteria

Exclusion criteria: Use of any medication. Smoking. Bleeding disorder. Previous spontaneous vagal collapse. History, signs or symptoms of cardiovascular disease. 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 120 µmol/l). Liver enzyme abnormalities or positive hepatitis serology. Positive HIV serology or any other obvious disease associated with immune deficiency. Febrile illness in the week before the LPS challenge. Participation in another drug trial or donation of blood 3 months prior to the planned LPS challenge.

Design outcomes

Primary

MeasureTime frame
The main study parameter is the concentration of circulating TNF-a following LPS administration.

Secondary

MeasureTime frame
Secondary study parameters include temperature, hemodynamic parameters (blood pressure and heart rate), illness score, catecholamines, heart rate variability, muscle sympathetic nerve activity, electroencephalography, other circulating cytokines (IL6, IL10 and IL1RA) and subclinical renal injury.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)