- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02864017
Immuno Nutrition by L-citrulline for Critically Ill Patients (Immunocitre)
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
This is a multicentric therapeutic trial, randomized and double blind: standard enteral nutrition plus L-citrulline (5 grams/12 Hours for 5 days from the admission in Intensive Care Unit (ICU)) versus standard enteral nutrition plus placebo.
Methods-Patients: Non-surgical patients admitted in medical intensive care unit, under mechanical ventilation for an expected duration > 2 days, without severe sepsis or septic shock, will be enrolled. Symptoms leading for ICU admission ongoing for five days maximum. On admission (before treatment), the severity will be evaluated with the Sepsis-related Organ Failure Assessment (SOFA) score together with an assessment of plasmatic arginine, cytokines (InterLeukin-6 (IL6) ), and expression of Human Leukocyte Antigen - antigen D Related (HLA-DR) by monocytes. The same evaluation will be repeated on day 3 (during treatment) and on day 7 (after treatment).
The enrolment of 100 patients is statistically enough to demonstrate a decreased SOFA scores in the L-citrulline group as compared to the placebo group on day 7.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
-
Angers, Frankrike
- Chu Angers
-
Nantes, Frankrike
- CHU Nantes
-
Paris, Frankrike
- Paris - HEGP
-
Rennes, Frankrike, 35033
- Rennes Hospital University
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- 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
Exclusion Criteria:
- severe sepsis
- septic shock
- obesity defined as BMI above 40
- pregnancy
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: L-Citrulline group
Enteral nutrition 5-day L-citrulline treatment (10 grams/day)
|
|
Placebo komparator: Control group
Enteral nutrition 5-day placebo treatment
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Organ failure score comparison D7
Tidsramme: At day 7
|
Organ failure score (SOFA score) on day 7 in the L-citrulline group as compared to the placebo group
|
At day 7
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Organ failure score comparison D3
Tidsramme: At day 3
|
Organ failure score (SOFA score) on day 3 in the L-citrulline group as compared to the placebo group
|
At day 3
|
SOFA score evolution between randomisation and D7
Tidsramme: up to 7 days
|
Binary criterion of success or failure : - Success is defined by: an improved SOFA score of at least 2 points from randomization to Day 7 or an improvement in the general condition yielding the release of the unit; - Failure is defined by an improved SOFA score but less than 2 points, no improvement or worsening of the SOFA score from randomization to Day 7 or the patient's death before J7; |
up to 7 days
|
Expression of HLA-DR
Tidsramme: At day 7
|
Expression of HLA-DR in the L-citrulline group as compared to the placebo group
|
At day 7
|
Plasmatic concentration of IL6
Tidsramme: At day 7
|
Comparison of the plasmatic concentration of interleukin-6 between the L-citrulline group and the placebo group
|
At day 7
|
HLA-DR
Tidsramme: At day 7
|
Comparison of the percentage of expression of monocytic HLA-DR between the L-citrulline group and the placebo group
|
At day 7
|
Plasmatic concentration of L-arginine
Tidsramme: At day 7
|
Comparison of the plasmatic concentration of L-arginine and its metabolites between the L-citrulline group and the placebo group
|
At day 7
|
Incidence of nosocomial infections
Tidsramme: during the stay in the ICU, an average of 7 days
|
Comparison between the L-citrulline group and the placebo group
|
during the stay in the ICU, an average of 7 days
|
Length of stay
Tidsramme: during the stay in hospital, up to 28 days
|
Length of stay in ICU and hospital: Comparison between the L-citrulline group and the placebo group
|
during the stay in hospital, up to 28 days
|
Mortality
Tidsramme: during the stay in hospital, up to 28 days
|
|
during the stay in hospital, up to 28 days
|
Duration of mechanical ventilation
Tidsramme: during the stay in ICU, an average of 7 days
|
Duration of mechanical ventilation: Comparison between the L-citrulline group and the placebo group
|
during the stay in ICU, an average of 7 days
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Jean-Marc TADIE, MD, CHU Rennes
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 35RC14_9835
- 2015-A00961-48 (Annen identifikator: Id-RCB)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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