Contact information
Type
Scientific
Primary contact
Dr Y.C. Luiking
ORCID ID
Contact details
University Maastricht
Department of Surgery
P.O. Box 5800
Maastricht
6102 AZ
Netherlands
+31 (0)43 3874427
yc.luiking@ah.unimaas.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR423; MEC 04-136
Study information
Scientific title
Acronym
Arginine-sepsis study
Study hypothesis
NO synthesis is compromised during sepsis through lack of L-arginine and may thereby contribute to impaired microcirculation and organ dysfunction. Supplementation of L-arginine in septic patients can replete L-arginine deficiency and will improve microcirculation, vascular permeability, and organ function.
Ethics approval
Received from local medical ethics committee
Study design
Randomised double blind placebo controlled parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Sepsis, Septic shock
Intervention
1. 3 days intravenous L-arginine infusion
2. 3 days intravenous L-alanine (placebo) infusion
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Microcirculation
Secondary outcome measures
1. Arginine metabolism
2. Hemodynamics
3. Vascular permeability
4. Organ functions
5. Disease severity scores
Overall trial start date
15/11/2004
Overall trial end date
31/12/2005
Reason abandoned
Eligibility
Participant inclusion criteria
1. Written informed consent from close relative
2. Age >18 years
3. Patient meets the general criteria for severe sepsis or septic shock (international published sepsis definitions), diagnosed less than 48 hours prior to study inclusion
4. Patient must be relatively hemodynamically stable, defined as stable blood pressure (variation in mean arterial pressure <15 mmHg) for 2 hours without necessity of increasing the vasopressor dose, inotropic support or rate of fluid administration
5. Systemic arterial catheter in place with continuous pressure monitoring
6. Patients in whom the clinician is prepared to provide full life support during the duration of the study
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
16
Participant exclusion criteria
1. Shock due to any cause other than sepsis (e.g. drug reaction or drug overdose, pulmonary embolus, burn injury, severe blood loss etc.)
2. Prolonged or high dose corticosteroid use
3. Liver cirrhosis
4. Chronic pancreatitis
5. Insulin-dependent diabetes mellitus
6. Metastases, haematological, malignancies or chemotherapy
7. Patients on dialysis (CVVH or other)
8. Pre-existent urea cycle disorders or renal failure
Recruitment start date
15/11/2004
Recruitment end date
31/12/2005
Locations
Countries of recruitment
Netherlands
Trial participating centre
University Maastricht
Maastricht
6102 AZ
Netherlands
Sponsor information
Organisation
Nutrition and Toxicology Research Institute Maastricht (NUTRIM) (Netherlands)
Sponsor details
P.O. Box 616
Maastricht
6200 MD
Netherlands
+31 (0)43 3881476
m.grispen@nutrim.unimaas.nl
Sponsor type
Not defined
Website
Funders
Funder type
Industry
Funder name
Novartis Consumer Health B.V. (Netherlands) R&D Nutrition
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary