Effect of Protein-Fortified Diet on Nitrogen Balance in Critically Ill Patients: Results from the OPINiB Trial

Danielis, Matteo; Lorenzoni, Giulia; Azzolina, Danila; Iacobucci, Anna; Trombini, Omar; Monte, Amato De; Gregori, Darío; Beltrame, Fabio

doi:10.3390/nu11050972

Cited by 19 publications

(13 citation statements)

References 28 publications

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“…Nitrogen balance was significantly better at all time points in protein-fortified group compared with standard diet group. By Day 3, nitrogen balance was positive in protein-fortified group and remained positive until study exit, whereas nitrogen balance was negative for all time points in the standard diet group [100].…”

Section: Mixed Source Interventionsmentioning

confidence: 89%

“…In another single-blind (outcome assessors were blinded), RCT (OPINiB; NCT02990065; N ¼ 40) a protein-fortified diet (protein target 1.8 g/kg/d) was compared with a standard diet (energy goal 20e25 kcal/kg/day) [100]. Protein intake was significantly higher (p < 0.001) in the protein-fortified group compared with control group at Days 1, 3, and study exit [103].…”

Section: Mixed Source Interventionsmentioning

confidence: 99%

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Review of evolution and current status of protein requirements and provision in acute illness and critical care

et al. 2021

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Nutrition therapy, by enteral, parenteral, or both routes combined, is a key component of the management of critically ill, surgical, burns, and oncology patients. Established evidence indicates overfeeding (provision of excessive calories) results in increased risk of infection, morbidity, and mortality. This has led to the practice of "permissive underfeeding" of calories; however, this can often lead to inadequate provision of guideline-recommended protein intakes. Acutely ill patients requiring nutritional therapy have high protein requirements, and studies demonstrate that provision of adequate protein can result in reduced mortality and improvement in quality of life. However, a significant challenge to adequate protein delivery is the current lack of concentrated protein solutions. Patients often have fluid administration restrictions and existing protein solutions are frequently not sufficiently concentrated to deliver a patient's protein requirements. This has led to the development of new enteral and parenteral nutrition solutions incorporating higher levels of protein in smaller volumes. This review article summarizes current evidence supporting the role of higher protein intakes, especially during the early phases of nutrition therapy in acute illness, methods for assessing protein requirements, as well as, the currently available high-protein enteral and parenteral nutrition solutions. There is sufficient evidence (albeit limited from true randomized, controlled studies) to indicate that earlier provision of guidelinerecommended protein intakes may be key to improving patient outcomes and that nutritional therapy that tailors caloric and protein intake to the patients' needs should be considered a desired standard of care.

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Section: Mixed Source Interventionsmentioning

confidence: 89%

Section: Mixed Source Interventionsmentioning

confidence: 99%

Review of evolution and current status of protein requirements and provision in acute illness and critical care

et al. 2021

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“…Nineteen RCTs totaling 1731 patients were included (sample size range: 14-474) [14,15,19,[24][25][26][27][28][29][30][31][32][33][34][35][36][37][38][39]. Study characteristics are summarized in Table 2.…”

Section: Studies and Patients Characteristicsmentioning

confidence: 99%

The effect of higher versus lower protein delivery in critically ill patients: a systematic review and meta-analysis of randomized controlled trials

et al. 2021

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Background The optimal protein dose in critical illness is unknown. We aim to conduct a systematic review of randomized controlled trials (RCTs) to compare the effect of higher versus lower protein delivery (with similar energy delivery between groups) on clinical and patient-centered outcomes in critically ill patients. Methods We searched MEDLINE, EMBASE, CENTRAL and CINAHL from database inception through April 1, 2021.We included RCTs of (1) adult (age ≥ 18) critically ill patients that (2) compared higher vs lower protein with (3) similar energy intake between groups, and (4) reported clinical and/or patient-centered outcomes. We excluded studies on immunonutrition. Two authors screened and conducted quality assessment independently and in duplicate. Random-effect meta-analyses were conducted to estimate the pooled risk ratio (dichotomized outcomes) or mean difference (continuous outcomes). Results Nineteen RCTs were included (n = 1731). Sixteen studies used primarily the enteral route to deliver protein. Intervention was started within 72 h of ICU admission in sixteen studies. The intervention lasted between 3 and 28 days. In 11 studies that reported weight-based nutrition delivery, the pooled mean protein and energy received in higher and lower protein groups were 1.31 ± 0.48 vs 0.90 ± 0.30 g/kg and 19.9 ± 6.9 versus 20.1 ± 7.1 kcal/kg, respectively. Higher vs lower protein did not significantly affect overall mortality [risk ratio 0.91, 95% confidence interval (CI) 0.75–1.10, p = 0.34] or other clinical or patient-centered outcomes. In 5 small studies, higher protein significantly attenuated muscle loss (MD −3.44% per week, 95% CI −4.99 to −1.90; p < 0.0001). Conclusion In critically ill patients, a higher daily protein delivery was not associated with any improvement in clinical or patient-centered outcomes. Larger, and more definitive RCTs are needed to confirm the effect of muscle loss attenuation associated with higher protein delivery. PROSPERO registration number: CRD42021237530

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“…Results of an observational study indicated a significant improvement in nitrogen balance with a protein intake of 1.5 g/kg/day vs a protein intake of 1.1 g/kg/day [ 22 ], a result similar to what we found in the two study groups. Nitrogen balance improved over 7 days in critically ill patients randomized to a protein-fortified diet versus those on a standard diet; differences between groups were significant [ 25 ].…”

Section: Discussionmentioning

confidence: 99%

“…Nitrogen balance remained negative at − 7 g/day. Even the Danielis study [ 25 ] shows the same negative nitrogen balance after 7 days with a protein intake of 1.8 g/kg/d, suggesting that nitrogen balance could not be the best parameter to follow to evaluate the efficacy of protein intake [ 28 ].…”

Section: Discussionmentioning

confidence: 99%

Feasibility of achieving different protein targets using a hypocaloric high-protein enteral formula in critically ill patients

et al. 2021

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Background and aims Combining energy and protein targets during the acute phase of critical illness is challenging. Energy should be provided progressively to reach targets while avoiding overfeeding and ensuring sufficient protein provision. This prospective observational study evaluated the feasibility of achieving protein targets guided by 24-h urinary nitrogen excretion while avoiding overfeeding when administering a high protein-to-energy ratio enteral nutrition (EN) formula. Methods Critically ill adult mechanically ventilated patients with an APACHE II score > 15, SOFA > 4 and without gastrointestinal dysfunction received EN with hypocaloric content for 7 days. Protein need was determined by 24-h urinary nitrogen excretion, up to 1.2 g/kg (Group A, N = 10) or up to 1.5 g/kg (Group B, N = 22). Variables assessed included nitrogen intake, excretion, balance; resting energy expenditure (REE); phase angle (PhA); gastrointestinal tolerance of EN. Results Demographic characteristics of groups were similar. Protein target was achieved using urinary nitrogen excretion measurements. Nitrogen balance worsened in Group A but improved in Group B. Daily protein and calorie intake and balance were significantly increased in Group B compared to Group A. REE was correlated to PhA measurements. Gastric tolerance of EN was good. Conclusions Achieving the protein target using urinary nitrogen loss up to 1.5 g/kg/day was feasible in this hypercatabolic population. Reaching a higher protein and calorie target did not induce higher nitrogen excretion and was associated with improved nitrogen balance and a better energy intake without overfeeding. PhA appears to be related to REE and may reflect metabolism level, suggestive of a new phenotype for nutritional status. Trial registration 0795-18-RMC.

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Effect of Protein-Fortified Diet on Nitrogen Balance in Critically Ill Patients: Results from the OPINiB Trial

Cited by 19 publications

References 28 publications

Review of evolution and current status of protein requirements and provision in acute illness and critical care

Review of evolution and current status of protein requirements and provision in acute illness and critical care

The effect of higher versus lower protein delivery in critically ill patients: a systematic review and meta-analysis of randomized controlled trials

Feasibility of achieving different protein targets using a hypocaloric high-protein enteral formula in critically ill patients

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