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L-citrulline Supplementation During 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: NCT00628381
Recruitment Status : Unknown
Verified September 2010 by Maastricht University Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : March 5, 2008
Last Update Posted : September 3, 2010
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by:
Maastricht University Medical Center

Brief Summary:
The purpose of this study is to study the stimulating effects of prolonged (8h) enteral L-citrulline supplementation on the normalisation of the plasma citrulline concentrations and the Arginine-NO metabolism, the microcirculation, the systemic hemodynamics, vascular permeability, and organ function and disease severity scores.

Condition or disease Intervention/treatment Phase
Sepsis Multiple Organ Failure Dietary Supplement: L-citrulline supplementation Dietary Supplement: L-alanine Phase 3

Detailed Description:
NO synthesis is compromised during sepsis through lack of arginine de novo synthesis and may thereby contribute to impaired microcirculation and organ dysfunction. Supplementation of L-citrulline in septic patients will increase NO production without increased arginase activity and these effects will be studied on arginine-NO metabolism,improved organ function, vascular permeability and microcirculation.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Arginine and Nitric Oxide (NO) Metabolism in Sepsis; L-citrulline Enteral Supplementation for the Normalisation of the Arginine-NO Metabolism
Study Start Date : January 2011
Estimated Primary Completion Date : January 2013
Estimated Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis
Drug Information available for: Alanine

Arm Intervention/treatment
Experimental: AA
24 ICU patients with severe sepsis will get a L-citrulline 8 h enteral supplementation.
Dietary Supplement: L-citrulline supplementation
L-citrulline, 1.8micromol/kg/min, during 8 hours continuously supplemented

Active Comparator: AB
24 ICU patients with severe sepsis will get an alternative isocaloric amino acid supplementation (L-alanine) during 8 hours
Dietary Supplement: L-alanine
L-alanine enteral infusion, isocaloric dosage (3.6 micromol/kg/min), during 8 hours, continuously supplemented

Primary Outcome Measures :
  1. To study stimulating effects of prolonged (8h) enteral L-citrulline supplementation on the normalisation of the arginine-NO metabolism [ Time Frame: 8 hours ]

Secondary Outcome Measures :
  1. Secondary study endpoints are the microcirculation, the vascular permeability and organ function scores. [ Time Frame: within 8 hours ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.
  • Patient must be relatively hemodynamically stable, defined as stable blood pressure (variation in mean arterial pressure <15 mm Hg) during 2h without necessity of increasing the vasopressor dose, inotropic support or rate of fluid administration.
  • Systemic arterial catheter in place with continuous pressure monitoring.
  • Patients in whom the clinician is prepared to provide full life support during the duration of the study

Exclusion Criteria:

  • Shock due to any cause other than sepsis (e.g. drug reaction or drug overdose, pulmonary embolus, burn injury etc.)
  • Prolonged or high dose corticosteroid use
  • Liver cirrhosis
  • Chronic pancreatitis
  • Insulin-dependent diabetes mellitus
  • Metastases, haematological malignancies or chemotherapy
  • Patients on dialysis (CVVH or other)
  • Pre-existent renal failure (on dialysis)

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): NCT00628381

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Contact: Nina Wijnands, MD, PhD-student +31-43-3884502
Contact: Martijn Poeze, MD, PhD +31-43-3874425

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University Hospital Maastricht
Maastricht, Limburg, Netherlands, 6202 AZ
Contact: Martijn Poeze, MD, PhD    +31-43 3876543   
Contact: Nina Wijnands, MD, PhD-student    +31-43-3884502   
Sponsors and Collaborators
Maastricht University Medical Center
ZonMw: The Netherlands Organisation for Health Research and Development
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Principal Investigator: Martijn Poeze, MD, PhD Department of Surgery
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Responsible Party: M.Poeze, MD, PhD,, Department of surgery, University hospital Maastricht Identifier: NCT00628381    
Other Study ID Numbers: MEC-08
ZON/NW 40-00806-98-114
First Posted: March 5, 2008    Key Record Dates
Last Update Posted: September 3, 2010
Last Verified: September 2010
Keywords provided by Maastricht University Medical Center:
nitric oxide
Additional relevant MeSH terms:
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Multiple Organ Failure
Systemic Inflammatory Response Syndrome
Pathologic Processes