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Completed

NCT Number: NCT01775020

Dose-response Study of Arginine Supplementation in Severe Sepsis

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.

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Key information

Conditions

Sepsis Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Septic Shock Shock Shock, Septic Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

L-Arginine

Dietary Supplement

Other names: L-arginine-HCl

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Collaborators

  • Novartis Medical Nutrition

Registry information

Official study 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.

Important dates

Study start
2003
Primary completion
2004
Study completion
2012
First posted
Jan 24, 2013
Registry last updated
Jan 29, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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