Status:
UNKNOWN
L-citrulline Supplementation During Sepsis
Lead Sponsor:
Maastricht University Medical Center
Collaborating Sponsors:
ZonMw: The Netherlands Organisation for Health Research and Development
Conditions:
Sepsis
Multiple Organ Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 me...
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 s...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2013
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00628381
Start Date
January 1 2011
End Date
January 1 2013
Last Update
September 3 2010
Active Locations (1)
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1
University Hospital Maastricht
Maastricht, Limburg, Netherlands, 6202 AZ