Severe sepsis or septic shock ICU patients.
Conditions
Interventions
1. 3-days intravenous L-arginine infusion
2. 3-days intravenous L-alalanine (placebo) infusion.
Sponsors
Novartis Consumer Health - R&D Nutrition.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Written informed consent from close relative; 2. Age > 18 years; 3. Patient meets the general criteria for severe sepsis or septic shock (International published sepsis definitions), diagnosed less than 48 h prior to study inclusion; 4. Patient must be relatively hemodynamically stable, defined as stable blood pressure (variation in mean arterial pressure <15 mm Hg) during 2 h without necessity of increasing the vasopressor dose, inotropic support or rate of fluid administration; 5. Systemic arterial catheter in place with continuous pressure monitoring; 6. Patients in whom the clinician is prepared to provide full life support during the duration of the study.
Exclusion criteria
Exclusion criteria: 1. Shock due to any cause other than sepsis (e.g. drug reaction or drug overdose, pulmonary embolus, burn injury, severe blood loss etc.); 2. Prolonged or high dose corticosteroid use; 3. Liver cirrhosis; 4. Chronic pancreatitis; 5. Insulin-dependent diabetes mellitus; 6. Metastases, haematological, malignancies or chemotherapy; 7. Patients on dialysis (CVVH or other); 8. Pre-existent urea cycle disorders or renal failure.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Microcirculation. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Arginine metabolism; 2. Hemodynamics; 3. Vascular permeability; 4. Organ functions; 5. Disease severity scores. | — |
Contacts
Public ContactY.C. Luiking
Danone Research - Centre for Specialised Nutrition PO Box 7005
Outcome results
None listed