Clinical trial NCT02968836: Safety and Efficacy of an Amino Acid Blend on Muscle and Gut Functionality in ICU Patients
Official title: Safety and Efficacy of an Amino Acid Blend on Muscle and Gut Functionality in ICU Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Enteral Nutrition
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2016-11-21
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Assessment of the Safety and efficacy of an amino acid blend on muscle and gut functionality in Intensive Care Unit (ICU) patients.

Since this was a proof of concept, exploratory trial, we assessed different primary outcomes without hierarchy.

Detailed description: This monocentric trial was a parallel, randomized, double-blind, controlled study. Patients hospitalized in the ICU for sepsis or ARDS were enrolled.

The treatment group (n=15) was administered the study product (amino acid blend) and the negative control group (=15) was administrated maltodextrin only. The mode of administration was nasogastric probe.

The treatment period was 21 days. Subject were followed during stay in High care and intermediate care units up to 2 months or after hospital discharge with a follow up until 12 months.

Recruitment stopped when 30 patients (15 in each group) reached V4.

Eligibility criteria: Inclusion Criteria:

1. Patients aged 18 and over
2. Sepsis or ARDS patients: expected to stay at least 21 days in ICU (or midcare), to the opinion of the investigator
3. Informed consent signed by the patient or/and by his/her representative

Exclusion Criteria:

1. Patient with muscle mass loss due to previous hospitalization
2. Intolerance to enteral feeding
3. Patients using parenteral feeding
4. Chronic renal failure to the opinion of the investigator
5. Chronic liver disease to the opinion of the investigator
6. Cachectic patients
7. Current treatment with paralyzing drugs
8. No pacemaker or metal implants interacting with MRI and magnetic stimulation
9. Pregnant woman (known)
10. Persons without social security
11. Under guardianship
12. Currently participating or having participated in another clinical trial within 4 weeks prior to trial start
13. Patient who is expected not to comply with the study procedures, to the opinion of the investigator

Primary outcomes:
measure: Safety: Renal function change
timeFrame: 60 days from the beginning of the intervention
measure: Efficacy: muscle functionality change
timeFrame: 12 months from the beginning of the intervention (timepoints: D1, D7, D14, D21, D60, D180, D365)
measure: Efficacy: gut barrier structure and functionality improvement
timeFrame: 12 months from the beginning of the intervention (timepoints: D1, D7, D14, D21, D60, D180, D365)
measure: Efficacy: inflammatory status change
timeFrame: 12 months from the beginning of the intervention (timepoints: D1, D7, D14, D21, D60, D180, D365)
measure: Efficacy: general recovery improvement
timeFrame: 12 months from the beginning of the intervention (timepoints: D1, D7, D14, D21, D60, D180, D365)
measure: Nutrient profiling
timeFrame: Over 60 days from the beginning of intervention (timepoints: D1, D7, D14, D21, D60)
Secondary outcomes:
Other outcomes:
Locations:
city: Garches
country: France
facility: Hôpital Raymond Poincaré (AP-HP)
Study officials:
affiliation: Raymond Poincaré Hospital, Garches, France
name: Djillali Annane, Pr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Heming N, Carlier R, Prigent H, Mekki A, Jousset C, Lofaso F, Ambrosi X, Bounab R, Maxime V, Mansart A, Crenn P, Moine P, Foltzer F, Cuenoud B, Konz T, Corthesy J, Beaumont M, Hartweg M, Roessle C, Preiser JC, Breuille D, Annane D. Effect of an enteral amino acid blend on muscle and gut functionality in critically ill patients: a proof-of-concept randomized controlled trial. Crit Care. 2022 Nov 17;26(1):358. doi: 10.1186/s13054-022-04232-5.