NCT01038622

Brief Summary

The main objective of this proof-of-concept study is to demonstrate that the only administration of L-arginine, based on a suspected deficit monitored by nasal nitric oxide measurement, can improve immune functions in critically ill patients at high risk of nosocomial infection.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Nov 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 22, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 24, 2009

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

September 18, 2013

Status Verified

December 1, 2009

Enrollment Period

1 year

First QC Date

December 22, 2009

Last Update Submit

September 17, 2013

Conditions

Critically Ill

Keywords

L-arginineNasal NONosocomial infectionImmune functionHLA-DR expressionCritically illMedical ICU patients

Outcome Measures

Primary Outcomes (1)

  • Expression of HLA-DR in the L-arginine group as compared to the placebo group

    on day 3

Secondary Outcomes (3)

  • HLA-DR on day 7, IL-10 and IL-17 on day 3 and 7, MDSC on day 3 and 7

    on day 3 and on day 7

  • Nosocomial infections

    in the first 15 days

  • Safety issue: organ failure score (SOFA score) on day 3 and 7; issue from ICU

    on day 3 and 7

Study Arms (2)

L-arginine

ACTIVE COMPARATOR

5-day L-arginine treatment (200 mg/kg)

Drug: L-arginine

placebo

PLACEBO COMPARATOR

5-day placebo treatment

Drug: placebo

Interventions

L-arginineDRUG

5-day L-arginine treatment

L-arginine
placeboDRUG

5-day placebo treatment

placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age \> 18 years
  • medical patient (absence of recent surgery or trauma)
  • initial aggression \< 5 days
  • mechanically ventilated with expected duration of mechanical ventilation \> 2 days
  • enteral nutrition
  • absence of previous immunosuppression
  • nasal NO on day 1 of ICU stay \< 60 ppb

You may not qualify if:

  • severe sepsis
  • septic shock
  • condition associated with a decreased nasal NO concentration (cystic fibrosis, nasal polyposis, primary ciliary dyskinesia
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Intensive Care Unit, Pompidou Hospital

Paris, 75015, France

Location

Related Publications (2)

  • Marik PE, Zaloga GP. Immunonutrition in critically ill patients: a systematic review and analysis of the literature. Intensive Care Med. 2008 Nov;34(11):1980-90. doi: 10.1007/s00134-008-1213-6. Epub 2008 Jul 15.

    PMID: 18626628RESULT

  • Tadie JM, Cynober L, Peigne V, Caumont-Prim A, Neveux N, Gey A, Guerot E, Diehl JL, Fagon JY, Tartour E, Delclaux C. Arginine administration to critically ill patients with a low nitric oxide fraction in the airways: a pilot study. Intensive Care Med. 2013 Sep;39(9):1663-5. doi: 10.1007/s00134-013-2984-y. Epub 2013 Jun 19. No abstract available.

    PMID: 23778831DERIVED

MeSH Terms

Conditions

Critical IllnessCross Infection

Interventions

Arginine

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsInfectionsIatrogenic Disease

Intervention Hierarchy (Ancestors)

Amino Acids, BasicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, DiaminoAmino Acids, Essential

Study Officials

  • Jean Marc TADIE, MD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2009

First Posted

December 24, 2009

Study Start

November 1, 2009

Primary Completion

November 1, 2010

Study Completion

January 1, 2011

Last Updated

September 18, 2013

Record last verified: 2009-12

Locations

FR(1)