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Dose-response Study of Arginine Supplementation in Severe Sepsis

NCT01775020 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2013-01-29

No results posted yet for this study

Summary

Pilot data in patients and data from pig studies indicate that arginine-NO metabolism is impaired in sepsis with changes in splanchnic metabolism and function, and reduced survival at low nitrate levels. Prolonged intravenous supplementation of L-arginine proved effective in pigs for increasing NO production, restoring gut function, and inhibiting an increase in pulmonary arterial pressure, without any deleterious systemic side effects. Prolonged intravenous L-arginine supplementation could therefore be useful in septic ICU patients.

Conditions

Interventions

DIETARY_SUPPLEMENT

L-arginine

Sponsors & Collaborators

  • Novartis Medical Nutrition

    collaborator UNKNOWN

  • Maastricht University Medical Center

    lead OTHER

Principal Investigators

  • Nicolaas E Deutz, MD PhD

Study Design

Allocation
NA
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-10-31
Primary Completion
2004-05-31
Completion
2012-05-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01775020 on ClinicalTrials.gov