Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
48 participants
INTERVENTIONAL
2011-01-31
2013-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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AA
24 ICU patients with severe sepsis will get a L-citrulline 8 h enteral supplementation.
L-citrulline supplementation
L-citrulline, 1.8micromol/kg/min, during 8 hours continuously supplemented
AB
24 ICU patients with severe sepsis will get an alternative isocaloric amino acid supplementation (L-alanine) during 8 hours
L-alanine
L-alanine enteral infusion, isocaloric dosage (3.6 micromol/kg/min), during 8 hours, continuously supplemented
Interventions
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L-citrulline supplementation
L-citrulline, 1.8micromol/kg/min, during 8 hours continuously supplemented
L-alanine
L-alanine enteral infusion, isocaloric dosage (3.6 micromol/kg/min), during 8 hours, continuously supplemented
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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ZonMw: The Netherlands Organisation for Health Research and Development
OTHER
Maastricht University Medical Center
OTHER
Responsible Party
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Department of surgery, University hospital Maastricht
Principal Investigators
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Martijn Poeze, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Surgery
Locations
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University Hospital Maastricht
Maastricht, Limburg, Netherlands
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Barr 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.
Lehr 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.
Wu 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.
Hallemeesch 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.
Other Identifiers
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ZON/NW 40-00806-98-114
Identifier Type: -
Identifier Source: secondary_id
MEC-08
Identifier Type: -
Identifier Source: org_study_id
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