A new high protein-to-energy enteral formula with a whey protein hydrolysate to achieve protein targets in critically ill patients: a prospective observational tolerability study

Eur J Clin Nutr. 2022 Mar;76(3):419-427. doi: 10.1038/s41430-021-00956-9. Epub 2021 Jun 24.

Abstract

Objectives: Current guidelines and expert recommendations stress the need to implement enteral feeds with a higher protein-to-energy ratio to meet protein requirements as recommended while avoiding gastrointestinal side effects and energy overfeeding in ICU patients.

Materials and methods: Prospective tolerability study in 18 critically ill patients with a high protein formula (high protein-to-energy (HP:E) formula = Fresubin® Intensive; HPG) compared to a contemporary matched conventional therapy group (CTG). The primary outcome was GI intolerance defined as ≥300 ml daily gastric residual volume (GRV), vomiting, or diarrhea on days 1 and 2. Secondary outcomes were the percentage of patients reaching their protein target on day 4 and overall protein intake.

Results: Groups were comparable regarding demographic characteristics, disease severity, organ failures, mechanical ventilation, and NUTRIC score at baseline. Eighteen patients completed the 4-day feeding period. The number of events of GRV of ≥300 ml/day was equal in both groups (33.3%). The incidence of diarrhea and vomiting was low in the HPG (two patients concerned). EN did not need to be discontinued due to intolerance in any group. Seventy-two percent of patients reached protein targets ≥1.3 g/kgBW/d within 4 days after initiation of enteral feeding, which was superior to the CTG (33%). Post-hoc testing showed group differences of protein intake between HPG and CTG were significant at t = 72 h and t = 96 h. Energy targets were met in both groups.

Conclusion: The HP:E formula containing 33% whey protein hydrolysate is well tolerated in this tolerability study. Due to the HP:E ratio protein targets can be reached faster. Larger randomized trials are needed to confirm preliminary results.

Trial registration: ClinicalTrials.gov Identifier: NCT02678325. Registered 2 May 2016.

Publication types

  • Observational Study

MeSH terms

  • Critical Illness* / therapy
  • Enteral Nutrition / methods
  • Humans
  • Intensive Care Units
  • Prospective Studies
  • Protein Hydrolysates* / adverse effects
  • Whey

Substances

  • Protein Hydrolysates

Associated data

  • ClinicalTrials.gov/NCT02678325