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

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 information

Study designRandomised double blind placebo controlled parallel group trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study acronymArginine-sepsis study
Study objectivesNO 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) studiedSepsis, Septic shock
Intervention1. 3 days intravenous L-arginine infusion
2. 3 days intravenous L-alanine (placebo) infusion
Intervention typeOther
Primary outcome measureMicrocirculation
Secondary outcome measures1. Arginine metabolism
2. Hemodynamics
3. Vascular permeability
4. Organ functions
5. Disease severity scores
Overall study start date15/11/2004
Completion date31/12/2005

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants16
Key inclusion criteria1. 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 criteria1. 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 enrolment15/11/2004
Date of final enrolment31/12/2005

Locations

Countries of recruitment

  • Netherlands

Study participating centre

University Maastricht
Maastricht
6102 AZ
Netherlands

Sponsor information

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

P.O. Box 616
Maastricht
6200 MD
Netherlands

Phone +31 (0)43 3881476
Email m.grispen@nutrim.unimaas.nl
ROR logo "ROR" 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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan