Arginine supplementation in severe sepsis: effects on metabolism and microcirculation

ISRCTN	ISRCTN56258935
DOI	https://doi.org/10.1186/ISRCTN56258935
Secondary identifying numbers	NTR423; MEC 04-136

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr Y.C. Luiking
Scientific

University Maastricht
Department of Surgery
P.O. Box 5800
Maastricht
6102 AZ
Netherlands

Phone	+31 (0)43 3874427
Email	yc.luiking@ah.unimaas.nl

Study design	Randomised double blind placebo controlled parallel group trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title
Study acronym	Arginine-sepsis study
Study objectives	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(s)	Received from local medical ethics committee
Health condition(s) or problem(s) studied	Sepsis, Septic shock
Intervention	1. 3 days intravenous L-arginine infusion 2. 3 days intravenous L-alanine (placebo) infusion
Intervention type	Other
Primary outcome measure	Microcirculation
Secondary outcome measures	1. Arginine metabolism 2. Hemodynamics 3. Vascular permeability 4. Organ functions 5. Disease severity scores
Overall study start date	15/11/2004
Completion date	31/12/2005

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	16
Key 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
Key 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
Date of first enrolment	15/11/2004
Date of final enrolment	31/12/2005

University Maastricht

Maastricht
6102 AZ
Netherlands

Nutrition and Toxicology Research Institute Maastricht (NUTRIM) (Netherlands)
Not defined

P.O. Box 616
Maastricht
6200 MD
Netherlands

Industry

Novartis Consumer Health B.V. (Netherlands) R&D Nutrition

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan