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
Recruitment status was Not yet recruiting
Sponsor:
Maastricht University Medical Center
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
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Sepsis Multiple Organ Failure |
Dietary Supplement: L-citrulline supplementation Dietary Supplement: L-alanine |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by Maastricht University Medical Center:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- Secondary study endpoints are the microcirculation, the vascular permeability and organ function scores. [ Time Frame: within 8 hours ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 48 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | January 2013 |
| Estimated Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00628381
Contacts
| 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 |
Locations
| Netherlands | |
| University Hospital Maastricht | Not yet recruiting |
| Maastricht, Limburg, Netherlands, 6202 AZ | |
| Contact: Martijn Poeze, MD, PhD +31-43 3876543 m.poeze@ah.unimaas.nl | |
| Contact: Nina Wijnands, MD, PhD-student +31-43-3884502 n.wijnands@ah.unimaas.nl | |
Sponsors and Collaborators
Maastricht University Medical Center
ZonMw: The Netherlands Organisation for Health Research and Development
Investigators
| Principal Investigator: | Martijn Poeze, MD, PhD | Department of Surgery |
More Information
Publications:
| Responsible Party: | M.Poeze, MD, PhD,, Department of surgery, University hospital Maastricht |
| ClinicalTrials.gov Identifier: | NCT00628381 History of Changes |
| Other Study ID Numbers: | MEC-08, ZON/NW 40-00806-98-114 |
| Study First Received: | February 26, 2008 |
| Last Updated: | September 2, 2010 |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Keywords provided by Maastricht University Medical Center:
|
sepsis microcirculation nitric oxide citrulline |
Additional relevant MeSH terms:
|
Multiple Organ Failure Sepsis Toxemia Shock Pathologic Processes Infection Systemic Inflammatory Response Syndrome Inflammation Nitric Oxide Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
Pharmacologic Actions Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses Free Radical Scavengers Antioxidants Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Endothelium-Dependent Relaxing Factors Vasodilator Agents Cardiovascular Agents Protective Agents |
ClinicalTrials.gov processed this record on May 23, 2013