NCT02864017

Brief Summary

The main objective of this study is to demonstrate that the only administration of L-citrulline, 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
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

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

First Submitted

Initial submission to the registry

August 4, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 11, 2016

Completed
21 days until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed
Last Updated

June 9, 2020

Status Verified

June 1, 2020

Enrollment Period

2.6 years

First QC Date

August 4, 2016

Last Update Submit

June 8, 2020

Conditions

IntubationPulmonary Ventilation

Outcome Measures

Primary Outcomes (1)

  • Organ failure score comparison D7

    Organ failure score (SOFA score) on day 7 in the L-citrulline group as compared to the placebo group

    At day 7

Secondary Outcomes (10)

  • Organ failure score comparison D3

    At day 3

  • SOFA score evolution between randomisation and D7

    up to 7 days

  • Expression of HLA-DR

    At day 7

  • Plasmatic concentration of IL6

    At day 7

  • HLA-DR

    At day 7

  • +5 more secondary outcomes

Study Arms (2)

L-Citrulline group

EXPERIMENTAL

Enteral nutrition 5-day L-citrulline treatment (10 grams/day)

Procedure: Enteral nutritionDietary Supplement: L-Citrulline

Control group

PLACEBO COMPARATOR

Enteral nutrition 5-day placebo treatment

Procedure: Enteral nutritionDietary Supplement: Placebo

Interventions

Enteral nutritionPROCEDURE
Control groupL-Citrulline group
L-CitrullineDIETARY_SUPPLEMENT
L-Citrulline group
PlaceboDIETARY_SUPPLEMENT
Control group

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
  • exclusive enteral nutrition
  • absence of previous immunosuppression

You may not qualify if:

  • severe sepsis
  • septic shock
  • obesity defined as BMI above 40
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

CHU Angers

Angers, France

Location

CHU Nantes

Nantes, France

Location

Paris - HEGP

Paris, France

Location

Rennes Hospital University

Rennes, 35033, France

Location

Related Publications (1)

  • Tadie JM, Locher C, Maamar A, Reignier J, Asfar P, Commereuc M, Lesouhaitier M, Gregoire M, Le Pabic E, Bendavid C, Moreau C, Diehl JL, Gey A, Tartour E, Le Tulzo Y, Thibault R, Terzi N, Gacouin A, Roussel M, Delclaux C, Tarte K, Cynober L. Enteral citrulline supplementation versus placebo on SOFA score on day 7 in mechanically ventilated critically ill patients: the IMMUNOCITRE randomized clinical trial. Crit Care. 2023 Oct 3;27(1):381. doi: 10.1186/s13054-023-04651-y.

    PMID: 37784110DERIVED

MeSH Terms

Interventions

Enteral NutritionCitrulline

Intervention Hierarchy (Ancestors)

Feeding MethodsTherapeuticsNutritional SupportNutrition TherapyAmino Acids, DiaminoAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Jean-Marc TADIE, MD

    CHU Rennes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2016

First Posted

August 11, 2016

Study Start

September 1, 2016

Primary Completion

April 1, 2019

Study Completion

April 1, 2020

Last Updated

June 9, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

FR(4)