Condition category
Infections and Infestations
Date applied
27/01/2006
Date assigned
27/01/2006
Last edited
17/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

Publication citations

Additional files

Editorial Notes