An Early Phase 1 interventional study of L-arginine in Sepsis and Septic Shock, sponsored by Maastricht University Medical Center. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-01-29.
Sponsored by Maastricht University Medical Center · Early Phase 1 and Interventional
Pilot data in patients and data from pig studies indicate that arginine-NO metabolism is impaired in sepsis with changes in splanchnic metabolism and function, and reduced survival at low nitrate levels. Prolonged intravenous supplementation of L-arginine proved effective in pigs for increasing NO production, restoring gut function, and inhibiting an increase in pulmonary arterial pressure, without any deleterious systemic side effects. Prolonged intravenous L-arginine supplementation could therefore be useful in septic ICU patients.
1,899 studies on the registry are indexed under Sepsis; 462 are open to participants now.
This study's enrollment of 8 is below the median of 105 across 896 interventional studies indexed under Sepsis.
Browse Sepsis studies →Maastricht University Medical Center is the lead sponsor of 835 studies on the registry; 122 are open to participants now.
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Exclusion Criteria:
L-arginine
Dietary Supplement: L-arginine
Also known as: L-arginine-HCl
Nitric oxide synthesis
Nitric oxide synthesis at step-wise increasing doses of L-arginine infusion. Following a 2h baseline measurements, 3 stepwise increasing arginine doses each provided for 2h will be tested for the effect on NO synthesis.
Time frame: 8 hours
hemodynamics
Mean arterial pressure (MAP), pulmonary arterial pressure (PAP), cardiac output (CO), cardiac index (CI), heart rate (HR)
Time frame: 8 hours
blood parameters
Blood gasses, electrolytes, glucose, insulin, amino acids, whole body protein and arginine metabolism
Time frame: 8 hours
gastric perfusion
Regional (gastric) CO2 production measured with tonometry (PrCO2)
Time frame: 8 hours
No study locations are listed for this record.
This study is completed, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.
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Maastricht University Medical Center