Trauma Clinical Trial
— ACCUMULATEOfficial title:
ImpACt of Very High Protein Content Enteral nUtrition Formulas on Protein Metabolism and Residual Gastric Volume in Critically Ill MUltipLe trAuma paTiEnts
This prospective observational randomized study aims to determine energy, protein intake and gastrointestinal tolerance while using enteral nutrition formulas with very high protein content and enteral nutrition formulas with normal protein content. - Differences regarding achieving protein and calorie daily targets when using enteral nutrition formulas with different protein content - Differences regarding residual gastric volume when using enteral nutrition formulas with different protein content - Differences regarding body composition when using enteral nutrition formulas with different protein content
Status | Not yet recruiting |
Enrollment | 70 |
Est. completion date | December 1, 2024 |
Est. primary completion date | December 1, 2023 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Adult patients (>18 yrs) admitted to the ICU - Multiple trauma (Injury severity score > 18) - Intubation and mechanical ventilation upon admission in ICU or during the first 24 hours of admission, for at least 48 h Exclusion Criteria: - Age < 18 years - Pregnant women - Patients not intubated or not mechanically ventilated or receiving only non-invasive ventilation - Patients with enteral feeding contraindication 48 h after admission - Patients with recent gastrointestinal surgical intervention - Patients on chronic therapy with corticosteroids |
Country | Name | City | State |
---|---|---|---|
Romania | Clinical Emergency Hospital of Bucharest | Bucharest |
Lead Sponsor | Collaborator |
---|---|
Romanian Society for Enteral and Parenteral Nutrition |
Romania,
Berger MM, Reintam-Blaser A, Calder PC, Casaer M, Hiesmayr MJ, Mayer K, Montejo JC, Pichard C, Preiser JC, van Zanten ARH, Bischoff SC, Singer P. Monitoring nutrition in the ICU. Clin Nutr. 2019 Apr;38(2):584-593. doi: 10.1016/j.clnu.2018.07.009. Epub 201 — View Citation
Singer P. Protein metabolism and requirements in the ICU. Clin Nutr ESPEN. 2020 Aug;38:3-8. doi: 10.1016/j.clnesp.2020.03.026. Epub 2020 May 31. — View Citation
Tedeschi-Jockers F, Reinhold S, Hollinger A, Tuchscherer D, Kiss C, Gantner L, Ledergerber K, Zimmermann S, Scheuzger J, Huber J, Siegemund M. A new high protein-to-energy enteral formula with a whey protein hydrolysate to achieve protein targets in criti — View Citation
van Zanten ARH, Petit L, De Waele J, Kieft H, de Wilde J, van Horssen P, Klebach M, Hofman Z. Very high intact-protein formula successfully provides protein intake according to nutritional recommendations in overweight critically ill patients: a double-bl — View Citation
Yasuda H, Kondo N, Yamamoto R, Asami S, Abe T, Tsujimoto H, Tsujimoto Y, Kataoka Y. Monitoring of gastric residual volume during enteral nutrition. Cochrane Database Syst Rev. 2021 Sep 27;9(9):CD013335. doi: 10.1002/14651858.CD013335.pub2. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Calorie and protein target | Differences regarding achieving protein and calorie daily targets in grams per kilogram of body weight (g/kg BW) at day 5 of the intervention period and at day 10 when using enteral nutrition formulas with different protein content | on day 5 days | |
Primary | Calorie and protein target | Differences regarding achieving protein and calorie daily targets in grams per kilogram of body weight (g/kg BW) at day 5 of the intervention period and at day 10 when using enteral nutrition formulas with different protein content | on day 10 | |
Secondary | Ultrasound-guided assessment of gastric residual volume | Differences regarding residual gastric volume when using enteral nutrition formulas with different protein content.
Ultrasound assessment of gastric volume using a current model for GV assessment based on antral cross-sectional area (CSA) - GV (ml)1/427.0+14.6×right-lateral CSA (cm2)21.28×age (yr) |
on day 5 | |
Secondary | Ultrasound-guided assessment of gastric residual volume | Differences regarding residual gastric volume when using enteral nutrition formulas with different protein content.
Ultrasound assessment of gastric volume using a current model for GV assessment based on antral cross-sectional area (CSA) - GV (ml)1/427.0+14.6×right-lateral CSA (cm2)21.28×age (yr) |
on day 10 | |
Secondary | Muscle function | Muscle function evaluation using handgrip dynamometer after extubation and sedation cessation | 24 hours after extubation | |
Secondary | Muscle function | Muscle function evaluation using handgrip dynamometer after extubation and sedation cessation | 5 days after extubation | |
Secondary | Body composition - Fat-free body mass | Fat-free body mass assessment using bioelectrical impedance analysis | 24 hours after extubation | |
Secondary | Body composition - Fat-free body mass | Fat-free body mass assessment using whole-body bioelectrical impedance | 5 days after extubation | |
Secondary | Body composition - Total body water | Total body water assessment using whole-body bioelectrical impedance analysis | 24 hours after extubation | |
Secondary | Body composition - Total body water | Total body water assessment using whole-body bioelectrical impedance analysis | 5 days after extubation | |
Secondary | Body composition - Phase angle | Phase angle measurement using whole-body bioelectrical impedance analysis | 24 hours after extubation | |
Secondary | Body composition - Phase angle | Phase angle measurement using whole-body bioelectrical impedance analysis | 5 days after extubation | |
Secondary | Body composition - ultrasound | Quadriceps rectus femoris thickness thickness measured by B-mode ultrasonography | baseline (on admission/first 24 hours) | |
Secondary | Body composition - ultrasound | Quadriceps rectus femoris thickness measured by B-mode ultrasonography | on day 5 | |
Secondary | Body composition - ultrasound | Quadriceps rectus femoris thickness measured by B-mode ultrasonography | on day 10 | |
Secondary | Body composition - ultrasound | Quadriceps rectus femoris thickness measured by B-mode ultrasonography | on day 15 | |
Secondary | Inflammation - CRP | Plasmatic levels of C-reactive protein | on day 5 | |
Secondary | Inflammation - CRP | Plasmatic levels of C-reactive protein | on day 10 | |
Secondary | Inflammation - prealbumin | Plasmatic levels of prealbumin | on day 5 | |
Secondary | Inflammation - prealbumin | Plasmatic levels of prealbumin | on day 10 |
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