Clinical efficacy of specialized enteral products in the complex therapy of ischemic stroke: a multicenter prospective randomized trial "CENTRIS"

   Rationale. A high level of disability among patients who have suff ered an ischemic stroke (IS) continues to remain a significant medico-social problem worldwide. Malnutrition and the development of nutritional defi ciency in post-stroke patients are common occurrences that signifi cantly worsen the overall prognosis for survival and functional recovery. Nutritional support (NS) as part of a comprehensive post-stroke rehabilitation program has a positive impact on clinical outcomes; however, the number of studies in this area is limited and warrants further investigation.

   Aim of the Study. To analyze the effectiveness and feasibility of using an algorithm of continuous nutritional support utilizing specialized enteral products as part of comprehensive therapy for patients with primary moderate severity IS during the acute and early recovery periods, in comparison with the current approach to nutrition using standard hospital diets.

   Material and Methods. A post-registration, open-label, multicenter, prospective, low-intervention, two-arm randomized study “CENTRIS” (C-clinical E-eff ectiveness N-nutrition T-therapy in R-rehabilitation after I-ischemic S-stroke). The material consisted of data from examinations of patients with an acute ischemic stroke (IS) at 4 research centers, obtained during 5 visits (B1-B5). Inclusion criteria: age 45–75 years; fi rst ischemic stroke, acute phase; Rehabilitation Routing Scale (RRS) score ≤ 3-5; Glasgow Coma Scale (GCS) score ≥ 13 points; presence of post-stroke dysphagia grades 1-4; nutritional deficiency identifi ed at baseline or during observation. The total duration of observation was 90 days. The observation period (90 days) included stages I and II of the acute periods (inpatient setting, 30 days) and stage III (outpatient setting, the fi rst 60 days of the early recovery period). Initially, all patients, after randomization, were divided into two groups: the intervention group (IG) and the control group (CG). In the IG group (n = 60), for the initial 30 days of hospitalization, patients received NS (nutritional support) in the form of specialized enteral nutrition (EN) products, administered according to their calculated daily energy requirements. If tube feeding (TF) was necessary, Nutrison Protein Advance was used; in the absence of the need for tube feeding, Nutridrink (totaling 600 kcal/day, 24 g protein/day) was administered orally via sipping in addition to the main diet. To correct post-stroke dysphagia and reduce the risk of aspiration, a method of thickening liquids and food was employed, involving the selection of a safe consistency (viscosity) for meals and beverages using the product Nutilis Clear. On day 30 (at discharge), patients in the IG group were randomized into two subgroups. Subgroup IG-1 (n = 32) continued a 60-day nutritional support (NS) regimen using the product Nutrison Advanced Nutridrink (200 ml, 300 kcal, 12 g protein per day, which corresponds to the nutritional value of 1 pack of Nutridrink 200 ml) as a supplement to their standard diet, utilizing the product Nutilis Clear for the correction of dysphagia via liquid and food thickening. Patients in subgroup IG-2 (n = 28) were transitioned to their usual home diet. In the control group (CG, n = 30), nutrition adhered to calculated requirements and management standards throughout the entire observation period. For the assessment of clinical effi cacy, the following indicators were used in the study groups: Nutritional status (weight measurement, concentrations of total protein, serum albumin, absolute blood lymphocyte count, Prognostic Nutritional Index (PNI)); Functional indicators and specialized scales: assessment of eating behavior (the Eating Assessment Tool-10, or EAT-10); swallowing ability and aspiration risk (the Mann Assessment of Swallowing Ability scale, or MASA);Assessment of daily activity and quality of life: muscle strength and endurance using hand-grip dynamometry; indicators of functional activity (the Barthel Index); the Rivermead Mobility Index (RMI); assessment of health-related quality of life using the EQ-5D-3L scale (TTO and VAS).

   Results. Over the observation period B1-B3 (30 days, inpatient), statistically significant advantages of the IG (intervention group) were identifi ed compared to the CG (control group) for the following indicators: Dynamics of improvement in the Prognostic Nutritional Index (PNI): (3.03 ± 5.14 vs –2.49 ± 4.728, p < 0.001); Increase in muscle strength and endurance via handgrip dynamometry data: (3.37 ± 4.47 vs 0.20 ± 6.46, p = 0.0225); Reduction in aspiration risk using the MASA scale (Mann Assessment of Swallowing Ability): (21.38 ± 11.604 vs 15.33 ± 15.535, p = 0.0408);Improvement in functional activity indicators (Barthel Index): (46.92 ± 26.539 vs 35 ± 22.819, p < 0.0386). A study of the results within the full 90-day observation period (V1-V5) allowed us to find convincing evidence of the superiority of the study group over the control group. Thus, weight loss was observed in both groups, but it was signifi cantly less in the IG compared to the CG according to the following indicators: calculated weight (–0.58 ± 2.9 kg vs –2.14 ± 2.69 kg, p = 0.0182) and measured weight (–0.32 ± 1.9 kg vs –1.9 ± 2.4 kg, p = 0.0015), respectively. Statistically significant advantages were identified in the IG compared to the CG in terms of increasing the growth of the following indicators: total protein (3.8 ± 5.7 g/L vs –1.32 ± 4.3 g/L, p < 0.001), serum albumin (2.2 ± 3.4 g/L vs –1.4 ± 3.7 g/L, respectively, p < 0.001), absolute blood lymphocyte count (0.5 ± 0.71 × 10^9/L vs 0.14 ± 0.67 × 10^9/L, p = 0.0233), and improvement in PNI dynamics (4.75 ± 4.93 vs –0.65 ± 5.57, p < 0.0001), respectively. The dynamics of the decrease in the level of indicators of dysphagia and its associated complications (EAT-10 scale) in the IG (intervention Group) was more pronounced compared to the CG (Control Group) (–13.25 ± 7.90 vs –9.73 ± 6.64, p = 0.048), which indicates the importance of using xanthan gum-based thickeners during the 90-day follow-up period. The Rivermead Mobility Index (RMI) (B5-B1) increment rates in the IG group were 18.3 % higher than in the CG (8.65 ± 2.661 vs 7.2 ± 2.809, p = 0.0189), with a positive growth trend of indicators in the subgroup (IG-1) by 25.24 % compared to the CG by day 90. The assessment of functional activity using the Barthel Index (specifically the “dependency” parameter) revealed that 37 % of patients in the intervention group (IG) were able to care for themselves independently without assistance by the end of the study (p = 0.0073). In the control group (CG), none of the patients could manage without constant or partial external assistance (p = 0.0386). The patients’ quality of life, as measured by the EQ-5D-3L questionnaire, improved in terms of quantitative scores, showing a significant leading increase of 28.95 % in the IG group (p = 0.0404)) compared to the CG over the period V5-V1. Quality of life of patients over the period from baseline (B1) to B5, according to the EQ-5D-3L questionnaire, improved in terms of quantitative assessment indicators with a reliable outstripping growth of 28.95 % in the IG group (p = 0.0404) compared to the CG, and a statistically significant indicator on the scale (EQ-5D-3L, VAS): the difference in the subjective assessment of quality of life improvement was 45.11 % (p = 0.0016) in favor of the IG (38.5 ± 19.964 vs 24.33 ± 18.41 in the CG). The obtained results confirm the effectiveness of an integrated approach to stroke therapy with the use of NS.

   Conclusion. The study results confirm the clinical efficacy of the developed algorithm for additional prolonged nutritional support (NS) compared to the standard protocol for patients with moderate ischemic stroke (IS). The use of specialized enteral nutrition (EN) products during the acute and early recovery periods (up to 90 days) statistically signifi cantly improves indicators of functional recovery and quality of life of patients.

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