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L-citrulline Supplementation During Sepsis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Maastricht University Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by:
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT00628381
First received: February 26, 2008
Last updated: September 2, 2010
Last verified: September 2010
History of Changes

February 26, 2008
September 2, 2010
January 2011
January 2013   (final data collection date for primary outcome measure)
To study stimulating effects of prolonged (8h) enteral L-citrulline supplementation on the normalisation of the arginine-NO metabolism [ Time Frame: 8 hours ] [ Designated as safety issue: No ]
To study stimulating effects of prolonged (72h) intravenous L-citrulline supplementation on the microcirculation, by gastric tonometry, sublingual orthogonal polarization spectral imaging (OPS), skin vascular blood flow by Laser-Doppler fluxmetry [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00628381 on ClinicalTrials.gov Archive Site
Secondary study endpoints are the microcirculation, the vascular permeability and organ function scores. [ Time Frame: within 8 hours ] [ Designated as safety issue: No ]
Secondary study endpoints are the arginine-NO metabolism using stable isotope infusion, vascular permeability assessed by the skin fluorescence of intravenously injected fluorescein, and organ function scores. [ Time Frame: within 72 hours ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
L-citrulline Supplementation During Sepsis
Arginine and Nitric Oxide (NO) Metabolism in Sepsis; L-citrulline Enteral Supplementation for the Normalisation of the Arginine-NO Metabolism

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.

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.
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Sepsis
  • Multiple Organ Failure
  • Dietary Supplement: L-citrulline supplementation
    L-citrulline, 1.8micromol/kg/min, during 8 hours continuously supplemented
  • Dietary Supplement: L-alanine
    L-alanine enteral infusion, isocaloric dosage (3.6 micromol/kg/min), during 8 hours, continuously supplemented
  • Experimental: AA
    24 ICU patients with severe sepsis will get a L-citrulline 8 h enteral supplementation.
    Intervention: Dietary Supplement: L-citrulline supplementation
  • Active Comparator: AB
    24 ICU patients with severe sepsis will get an alternative isocaloric amino acid supplementation (L-alanine) during 8 hours
    Intervention: Dietary Supplement: L-alanine

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
48
January 2013
January 2013   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact: Nina Wijnands, MD, PhD-student +31-43-3884502 n.wijnands@ah.unimaas.nl
Contact: Martijn Poeze, MD, PhD +31-43-3874425 m.poeze@ah.unimaas.nl
Netherlands
 
NCT00628381
MEC-08, ZON/NW 40-00806-98-114
Yes
M.Poeze, MD, PhD,, Department of surgery, University hospital Maastricht
Maastricht University Medical Center
ZonMw: The Netherlands Organisation for Health Research and Development
Principal Investigator: Martijn Poeze, MD, PhD Department of Surgery
Maastricht University Medical Center
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP