the Influence of Remote Ischemic Preconditioning on Inflammation During Human Endotoxemia

EARLY_PHASE1CompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

October 31, 2015

Primary Completion Date

March 31, 2016

Study Completion Date

March 31, 2016

Conditions
Autoimmune DiseasesInfection
Interventions
OTHER

Multiple-dose Remote Ischemic Preconditioning

"A blood-pressure cuff with handheld rubber inflation balloon and manometer is placed on the non-dominant arm of the subject. The cuff will be placed proximally from the elbow with the most proximal part of the cuff placed in the armpit. The cuff will be inflated to 250 mmHg after which a 5 minute countdown is started. After 5 minutes the pressure is released and the 5 minute countdown for reperfusion is started. This concludes one cycle out of a total of four.~1 RIPC-dose consists of 4 cycles of 5 minute ischemia followed by 5 minute reperfusion as described above.~Multiple-dose RIPC consists of a daily dose of 1 RIPC as described above for 7 consecutive days."

OTHER

Single-dose Remote Ischemic Preconditioning

"A blood-pressure cuff with handheld rubber inflation balloon and manometer is placed on the non-dominant arm of the subject. The cuff will be placed proximally from the elbow with the most proximal part of the cuff placed in the armpit. The cuff will be inflated to 250 mmHg after which a 5 minute countdown is started. After 5 minutes the pressure is released and the 5 minute countdown for reperfusion is started. This concludes one cycle out of a total of four.~1 RIPC-dose consists of 4 cycles of 5 minute ischemia followed by 5 minute reperfusion as described above.~Single-dose RIPC consists of 1 dose of RIPC as described above"

BIOLOGICAL

LPS infusion

To achieve a controlled inflammatory state, 30 subjects (multiple-dose RIPC group \[n=10\], single-dose RIPC group \[n=10\] and control group \[n=10\]) will receive LPS intravenously. The LPS at a dose of 2 ng/kg iv will be injected in 1 minute.

Trial Locations (1)

6525 GA

Radboud University Medical Centre, Intensive Care, Nijmegen

All Listed Sponsors
lead

Radboud University Medical Center

OTHER

NCT02602977 - the Influence of Remote Ischemic Preconditioning on Inflammation During Human Endotoxemia | Biotech Hunter | Biotech Hunter