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Sponsors and Collaborators: |
Maastricht University Medical Center ZonMw: The Netherlands Organisation for Health Research and Development |
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Information provided by: | Maastricht University Medical Center |
ClinicalTrials.gov Identifier: | NCT00628381 |
The purpose of this study is to study the stimulating effects of prolonged (72h) intravenous L-citrulline supplementation on the microcirculation, on the Arginine-NO metabolism, systemic hemodynamics, vascular permeability, and organ function and disease severity scores.
Condition | Intervention | Phase |
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Sepsis Multiple Organ Failure |
Drug: L-citrulline infusion Drug: L-alanine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Arginine and Nitric Oxide (NO) Metabolism in Sepsis; Effects of 72h L-Citrulline Supplementation on Whole Body and Splanchnic Microcirculation in Severely Septic Patients |
Estimated Enrollment: | 24 |
Study Start Date: | March 2009 |
Estimated Study Completion Date: | July 2010 |
Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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AA: Experimental
16 ICU patients with severe sepsis will get a L-citrulline 72 h intravenous supplementation. 8 patients will be conducted in a PILOT phase to examine the dose-response of L-citrulline. The other 8 patients will be enrolled later in this study, together with the patients in the placebo group. |
Drug: L-citrulline infusion
L-citrulline, dosage will be determined in a PILOT study, during 72 hours continuously infused.
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AB: Active Comparator
8 ICU patients with severe sepsis will get a placebo infusion (L-alanine) during 72 hours
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Drug: L-alanine
L-alanine intravenous infusion, isocaloric doses (determined in PILOT phase of this study), during 72 hours, continuously infused
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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, Limburg | |
University Hospital Maastricht | |
Maastricht, Limburg, Netherlands, 6202 AZ |
Principal Investigator: | Martijn Poeze, MD, PhD | Department of surgery |
Responsible Party: | Department of surgery, University hospital Maastricht ( M.Poeze, MD, PhD, ) |
Study ID Numbers: | MEC-08, ZON/NW 40-00806-98-114 |
Study First Received: | February 26, 2008 |
Last Updated: | January 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00628381 |
Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
sepsis microcirculation nitric oxide citrulline |
Nitric Oxide Systemic Inflammatory Response Syndrome Sepsis |
Shock Multiple Organ Failure Inflammation |
Pathologic Processes Infection |