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 |
- Submission date
- 27/01/2006
- Registration date
- 27/01/2006
- Last edited
- 17/08/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
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
Contact information
Dr Y.C. Luiking
Scientific
Scientific
University Maastricht
Department of Surgery
P.O. Box 5800
Maastricht
6102 AZ
Netherlands
Phone | +31 (0)43 3874427 |
---|---|
yc.luiking@ah.unimaas.nl |
Study information
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 |
Eligibility
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 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
University Maastricht
Maastricht
6102 AZ
Netherlands
6102 AZ
Netherlands
Sponsor information
Nutrition and Toxicology Research Institute Maastricht (NUTRIM) (Netherlands)
Not defined
Not defined
P.O. Box 616
Maastricht
6200 MD
Netherlands
Phone | +31 (0)43 3881476 |
---|---|
m.grispen@nutrim.unimaas.nl | |
https://ror.org/02jz4aj89 |
Funders
Funder type
Industry
Novartis Consumer Health B.V. (Netherlands) R&D Nutrition
No information available
Results and Publications
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 |