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Dose-response Study of Arginine Supplementation in Severe Sepsis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01775020
Recruitment Status : Completed
First Posted : January 24, 2013
Last Update Posted : January 29, 2013
Novartis Medical Nutrition
Information provided by (Responsible Party):
Maastricht University Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Sepsis Septic Shock Dietary Supplement: L-arginine Early Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Arginine and Nitric Oxide (NO) Metabolism in Sepsis; Dose-response Study on the Effect of L-arginine Supplementation on NO Metabolism and Gastric Perfusion in Severe Septic Patients.
Study Start Date : October 2003
Primary Completion Date : May 2004
Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis
U.S. FDA Resources

Arm Intervention/treatment
Experimental: L-arginine
Dietary Supplement: L-arginine
Other Name: L-arginine-HCl

Primary Outcome Measures :
  1. Nitric oxide synthesis [ Time Frame: 8 hours ]
    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.

Secondary Outcome Measures :
  1. hemodynamics [ Time Frame: 8 hours ]
    Mean arterial pressure (MAP), pulmonary arterial pressure (PAP), cardiac output (CO), cardiac index (CI), heart rate (HR)

  2. blood parameters [ Time Frame: 8 hours ]
    Blood gasses, electrolytes, glucose, insulin, amino acids, whole body protein and arginine metabolism

  3. gastric perfusion [ Time Frame: 8 hours ]
    Regional (gastric) CO2 production measured with tonometry (PrCO2)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Written informed consent from close relative
  • Age > 18 years
  • Patient meets the general criteria for severe sepsis or septic shock, diagnosed less than 48 h prior to study inclusion (see appendix A; in Dutch).
  • 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.
  • Systemic and pulmonary arterial catheters in place with continuous pressure monitoring.
  • Patients in whom the clinician is prepared to provide full life support during the duration of the study, including a life expectance of > 24 h.

Exclusion Criteria:

  • Shock due to any cause other than sepsis (e.g. drug reaction or drug overdose, pulmonary embolus, burn injury etc.)
  • Corticosteroid use (prolonged intake of > 1mg/kg daily or intake of > 70 mg/day for 7 consecutive days within 1 month preceding the study)
  • Liver cirrhosis
  • Chronic pancreatitis
  • Diabetes mellitus type I
  • Metastases, haematological malignancies or chemotherapy
  • Patients on dialysis (CVVH or other)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01775020

Sponsors and Collaborators
Maastricht University Medical Center
Novartis Medical Nutrition
Principal Investigator: Nicolaas E Deutz, MD PhD