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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Gasotransmitters
Protective Agents

ClinicalTrials.gov processed this record on August 25, 2014