External Surface Cooling In huMan endOtoxemia

External Surface Cooling In huMan endOtoxemia - ESCIMO

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON45163

Enrollment

Registered

2016-10-14

Start date

2017-05-10

Completion date

Unknown

Last updated

2024-06-11

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

Conditions

endotoxemia Sepsis

Interventions

Group 1: LPS + medication + external cooling to 36°C from T = 0 hours after LPS infusion Group 2: LPS + medication+ external cooling to 36°C from T = 3 hours after LPS infusion Group 3: LPS Group 4:

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Healthy male volunteer 2. Age >= 18 years

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
A significant decrease in plasma Il-6 levels	—

Secondary

Measure	Time frame
Other markers of 1. host immune response 2. coagulation 3. tissue perfusion and oxygenation 4. neurovascular coupling	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)