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
2 other identifiers
interventional
48
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 sepsis
Started Jan 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 26, 2008
CompletedFirst Posted
Study publicly available on registry
March 5, 2008
CompletedStudy Start
First participant enrolled
January 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2013
CompletedSeptember 3, 2010
September 1, 2010
2 years
February 26, 2008
September 2, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To study stimulating effects of prolonged (8h) enteral L-citrulline supplementation on the normalisation of the arginine-NO metabolism
8 hours
Secondary Outcomes (1)
Secondary study endpoints are the microcirculation, the vascular permeability and organ function scores.
within 8 hours
Study Arms (2)
AA
EXPERIMENTAL24 ICU patients with severe sepsis will get a L-citrulline 8 h enteral supplementation.
AB
ACTIVE COMPARATOR24 ICU patients with severe sepsis will get an alternative isocaloric amino acid supplementation (L-alanine) during 8 hours
Interventions
L-citrulline, 1.8micromol/kg/min, during 8 hours continuously supplemented
L-alanine enteral infusion, isocaloric dosage (3.6 micromol/kg/min), during 8 hours, continuously supplemented
Eligibility Criteria
You may qualify if:
- Written informed consent from close relative
- Age \> 18 years
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Maastricht
Maastricht, Limburg, 6202 AZ, Netherlands
Related Publications (5)
Rouge C, Des Robert C, Robins A, Le Bacquer O, Volteau C, De La Cochetiere MF, Darmaun D. Manipulation of citrulline availability in humans. Am J Physiol Gastrointest Liver Physiol. 2007 Nov;293(5):G1061-7. doi: 10.1152/ajpgi.00289.2007. Epub 2007 Sep 27.
PMID: 17901164BACKGROUNDBarr FE, Tirona RG, Taylor MB, Rice G, Arnold J, Cunningham G, Smith HA, Campbell A, Canter JA, Christian KG, Drinkwater DC, Scholl F, Kavanaugh-McHugh A, Summar ML. Pharmacokinetics and safety of intravenously administered citrulline in children undergoing congenital heart surgery: potential therapy for postoperative pulmonary hypertension. J Thorac Cardiovasc Surg. 2007 Aug;134(2):319-26. doi: 10.1016/j.jtcvs.2007.02.043.
PMID: 17662768BACKGROUNDLehr HA, Bittinger F, Kirkpatrick CJ. Microcirculatory dysfunction in sepsis: a pathogenetic basis for therapy? J Pathol. 2000 Feb;190(3):373-86. doi: 10.1002/(SICI)1096-9896(200002)190:33.0.CO;2-3.
PMID: 10685071BACKGROUNDWu G, Morris SM Jr. Arginine metabolism: nitric oxide and beyond. Biochem J. 1998 Nov 15;336 ( Pt 1)(Pt 1):1-17. doi: 10.1042/bj3360001.
PMID: 9806879BACKGROUNDHallemeesch MM, Lamers WH, Deutz NE. Reduced arginine availability and nitric oxide production. Clin Nutr. 2002 Aug;21(4):273-9. doi: 10.1054/clnu.2002.0571.
PMID: 12135586BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Martijn Poeze, MD, PhD
Department of Surgery
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 26, 2008
First Posted
March 5, 2008
Study Start
January 1, 2011
Primary Completion
January 1, 2013
Study Completion
January 1, 2013
Last Updated
September 3, 2010
Record last verified: 2010-09