A study on nutritional status, the results of an oral nutritional supplement on maintenance hemodialysis patients

zed based on etiology, glomerular filtration rate, and albuminuria. Renal replacement therapy, including peritoneal dialysis, hemodialysis, or kidney transplantation. The primary cause of CKD is diverse, depending on the region, continent, economic status, and medical development of each country. The incidence and treatment of end-stage chronic kidney disease are increasing in countries over the world. * Renal replacement therapy by hemodialysis Hemodialysis continues to be the most common treatment for end-stage chronic kidney disease in all countries, which is a method of dialysis outside the body, by creating an external circulating body, leading blood to the filtration system to filter metabolic products and excess water. The blood is returned to the body. Hemodialysis procedure only replaces the renal excretion function, so patients still need internal medical treatment: medical nutritional therapy, treatment of hypertension, anemia, vitamins, and mineral supplements. MALNUTRITION IN PATIENTS WITH CHRONIC KIDNEY DISEASE According to the definition of the WHO, malnutrition is a state of deficiency, excess, or imbalance in the energy and, or nutrients of a person. The ISRNM 2008 uses the term protein-energy wasting (PEW) in chronic kidney disease. Evidence suggests that malnutrition is common in patients with CKD conserving treatment, hemodialysis, or peritoneal dialysis. There are many possible causes of malnutrition in hemodialysis patients, including low nutrient intake, increased metabolism, acidosis, inflammation, anemia, oxidative stress, changes in response to anabolic hormones, increased retention of toxic substances, loss of nutrients in dialysis, and comorbidities. There are independent, overlapping, complementary, or antagonistic mechanisms that it difficult to troubleshoot their effects on protein metabolism and energy balance. Malnutrition cause increasing in morbidity and mortality, poor quality of life, length of stay, and re-admission in CKD patients. * Methods of assessing nutritional status There are many methods for evaluating malnutrition in patients with CKD. However, useful clinical tools are illustrated by the nutrition care guidelines developed by K/DOQI. - Anthropometric measurements: weight, body mass index, skinfolds thickness, mid-arm circumference, mid-arm muscle circumference, and arm muscle area. - Diet and food use. - Subjective global assessment-Dialysis malnutrition score. - Laboratory parameters: serum protein, albumin, prealbumin, total cholesterol, red blood cells, hemoglobin, lymphocytes. - Protein-energy wasting, according to ISRNM 2008 criteria. * The nutritional requirement in hemodialysis patients Dietary energy intake (DEI): K/DOQI 2000 recommends DEI 30 to 35 kcal/kg/day (over 60 years old), at least 35 kcal/kg/day (under 60). Dietary protein intake (DPI): K/DOQI 2000 recommends DPI at least 1.2 g/kg/day. * Eggs are a rich source of dietary cholesterol and are a nutritious whole food, so they should be judged based on total intake rather than specific components, like cholesterol. Although there are concerns about regular egg consumption that may be associated with a risk of cardiovascular disease due to cholesterol levels. Most epidemiological studies were claiming to use one egg a day did not increase cardiovascular disease, coronary artery disease, or stroke. * Treatment of hemodialysis patients with malnutrition In hemodialysis patients who are malnourished or at risk of malnutrition, there is no single treatment approach that significantly reduces the negative consequences of malnutrition, including. - Nutritional counseling - Oral nutritional supplement - Intradialytic parental nutrition - Enteral and total parental nutrition. CHAPTER 2 METHODOLOGY 2.1. RESEARCH SUBJECT - Maintenance hemodialysis patients. - Location: Department of Nephrology and Hemodialysis, 103 Military Hospital. - Study period: from March 2016 to January 2018. 2.1.1. Subject criteria for evaluation of the nutritional status - Inclusion criteria: Over 18 years of old patients; at least three months of dialysis, dialysis three times a week, 4 hours each time. - Exclusion criteria: severe acute illness, severe chronic heart failure, severe liver failure, advanced cancer, deaf and dumb, or non-cooperative research. 2.1.2. Subject criteria for the intervention study - Inclusion criteria: Patients with energy and protein intake below recommended; malnutrition is determined by BMI, SGA-DMS, serum albumin, prealbumin level. - Exclusion criteria: Having surgery three months before, during, or dying during the intervention; are allergic to milk, eggs; disagree to participate in intervention research, or did not fulfill commitments. 2.2. RESEARCH METHODOLOGY 2.2.1. Research design The study design consists of two consecutive research methods: the cross-sectional descriptive study and intervention study. 2.2.2. Sample sizes and sampling methods - Cross-sectional study: the whole sample, according to the chronological order, 173 patients. - Intervention study: 79 patients were divided into intervention group and control group according to their dialysis schedule: patients with dialysis schedule on Monday/Wednesday/Friday of the week were enrolled in the intervention group, while those on Tuesday, Thursday, and Saturday of the week were into the control group. Thirty-nine patients participated in supplementation of diet (intervention group); 40 patients did not participate in supplementation (control group). 2.2.3. Implementation of the intervention study * Research materials: The supplementary diet consisted of 48 g of Nepro2 and one chicken egg (average 42 g) daily for 12 consecutive weeks. This regimen provides about 259 kcal, 14.9 g of high biological value protein. * Implement supplement intervention - Treatment for both groups: according to a uniform procedure. - Intervention group: patients were advised on a daily diet, oral supplementation diet, for 12 consecutive weeks. - Control group: patients were only counseled on a regular diet and did not participate in the dietary supplement. - Compliance assessment: sitting and watching them, make sure that they ate the entire supplement, or ate at least 70% of the dietary supplement. Also, call, remind, and return the package to the next filtration. 2.2.4. Data collection * The patients’ information * Some diagnostic criteria used in the study: CKD and some cause. * Collecting information, criteria for assessing nutritional status - Anthropometric indicators: dry weight, height, calculation of BMI, triceps skinfold, mid-arm circumference, calculation of the mid-arm muscle circumference, and arm muscle area. BMI is classified by the WHO. Body composition indexes are categorized by Blackburn and Harvey, and Frisancho. - Dietary energy and protein intake Evaluation by the 24-hour recall for three days. The calculation is based on the Vietnam Food Ingredient Table 2016, average over three days, based on ideal body weight. Compare with K/DOQI. - Subjective global assessment-Dialysis malnutrition score This tool consists of seven components. Each part is rated on a scale of 1 to 5. The total score ranges from 7 to 35, the higher the score, the worse the nutritional status is. Classification of nutritional status into the healthy group (7-10 points), mild and moderate malnutrition (11-21 points), and severe malnutrition (22-35 points). - Laboratory parameters The venous blood sample is taken before the start of the dialysis section, including the concentration of serum albumin, prealbumin. Besides, the evaluation of serum protein, total cholesterol, urea, creatinine, and high sensitive CRP. Hematological indicators such as red blood cell, hemoglobin, lymphocytes. Classification of serum albumin and prealbumin levels based on K/DOQI 2000 guidelines. - Diagnosis of malnutrition, according to the International Society of Renal Nutrition & Metabolism (ISRNM 2008) * Evaluation of the results of an oral nutritional supplement Patients were assessed for nutritional status and general features at baseline and after 12 weeks of supplementation diet in the intervention and control group with the following indicators BMI, SGA-DMS, the concentration of serum protein, albumin, total cholesterol, red blood cell count, and hemoglobin level. CHAPTER 3 RESULTS 3.1. GENERAL CHARACTERISTICS OF STUDY SUBJECTS 3.1.1. Characteristics of age and gender The mean age of subjects was 53.0 ± 14.6 years old, ranging from 24 to 89. The under-65 group accounted for 73.4% of patients (n=127). Males accounted for 62.4% (n=108) of patients. 3.1.2. Cause of chronic kidney disease Chronic glomerulonephritis causes CKD, with a majority with 57.2%, diabetes mellitus accounted for 13.9% of patients. 3.1.3. Features of the hemodialysis vintage The median, quartiles dialysis time was 23 (10-55) months. The under five year HV group accounted for mainly 77.4% (n=134) of patients. 3.1.4. Characteristics of appetite status Patients with normal appetite status (good and very good) accounted for 22.0% of patients, and loss appetite status accounted for 78.0% (very poor, poor, and fairly). 3.1.5. Characteristics of dietary energy and protein intake The means DEI, DPI, and HBV protein of patients were 24.9 ± 4.2 kcal/IBW/day, 0.95 ± 0.17 g/IBW/day, and 52.9 ± 6.7%, respectively. There were 67.6% of patients prioritizing using high biological value protein in their diet (≥ 50%). Chart 3.5. Percentage of patients achieving DEI and DPI requirements according to K/DOQI 2000 93.1% of patients did not meet both DEI and DPI requirements. 3.1.6. Characteristics of some laboratory parameters The percentage of patients with serum total cholesterol concentration, red blood cell count, hemoglobin concentration, count, and percentage of peripheral blood lymphocytes below the standard threshold were high, with 57.8%, 89.0%, 91.3%, 35.8%, and 60.7%, respectively. 3.2. NUTRITION STATUS OF THE STUDY SUBJECTS 3.2.1. Dry weight and BMI Table 3.1. Characteristics of weight and BMI (n=173) Variables Number Prevalence % ± SD Weight, kg - 51.5 ± 9.1 BMI, kg/m2 < 16 9 5.2 19.7 ± 2.6 16-18,5 51 29.5 18,5-24,9 107 61.8 ≥ 25 6 3.5 The prevalence of malnutrition, according to BMI criteria, was 34.7%, in which severe malnutrition was 5.2% of patients. 3.2.2. Body composition The prevalence of malnutrition, according to TSF, MAC, MAMC, AMA criteria, was 11.6% (n=20), 30.6% (n=55), 16.2% (n=28), and 60.7% (n=105) of patients, respectively. 3.2.3. SGA-DMS Table 3.2. Nutritional status according to SGA-DMS (n=173) SGA-DMS, score Number Prevalence % ± SD 7-10 25 14.5 15.2 ± 4.3 11-21 134 77.5 22-35 14 8.1 All 173 100 The malnutrition rate (SGA-DMS > 10) was 85.5% (n=148), in which mild-moderate malnutrition (11-21) accounted for 77.5% (n=134), severe malnutrition (22-35) was 8.1% (n=14) of patients. 3.2.4. Biochemical parameters The prevalences of malnutrition, according to serum albumin and prealbumin criteria, were 67.6% (n=117) and 57.6% (n=98) of patients. 3.2.5. Nutritional status when combining indicators The percentage of malnourished patients, when all four criteria are present, is 16.5% — meanwhile, 4.1% of patients in the normal range for all four indicators. 3.2.6. Protein-energy wasting according to ISRNM 2008 The prevalence of PEW, according to ISRNM criteria (including BMI, AMA, DPI, and serum albumin), was 24.3% (n=42). 3.3. RELATIONSHIP BETWEEN NUTRITION INDICATORS WITH SOME CLINICAL AND LABORATORY FEATURES, AND INITIAL RESULTS OF AN ORAL NUTRITIONAL SUPPLEMENT ON NUTRITIONAL STATUS IN HEMODIALYSIS PATIENTS 3.3.1. Correlation between indicators of nutritional status Table 0.1. Correlation between indicators of nutritional status SGA-DMS (score) BMI (kg/m2) DEI (kcal/kg/day) DPI (g/kg/day) sAlbumin (g/l) r p r p r p r p r p BMI -0,22 0,004e DEI -0,47 <0,001e 0,42 <0,001a DPI -0,48 <0,001e 0,37 <0,001a 0,85 <0,001a Albumin -0,32 <0,001e 0,17 0,029a 0,35 <0,001a 0,33 <0,001a Prealbumin -0,36 <0,001e 0,09 0,222e 0,39 <0,001e 0,30 <0,001e 0,51 <0,001e a: Pearson correlation; e: Spearman correlation, sAlbumin: serum albumin SGA-DMS score were negatively correlated with BMI, DEI, DPI, serum albumin, prealbumin level. BMI was positively correlated with DEI, DPI, and serum albumin level. DEI and DPI were positively correlated, positively correlated with serum albumin and prealbumin levels. 3.3.2. Relationship between nutrition indicators and some variables 3.3.2.1. Body mass index with some features There is no difference in BMI with age (over and under 60 years old), duration of dialysis (over and under five years), causes (diabetes and others), appetite status (normal and decreased), the concentration of hsCRP (normal and high). 3.3.2.2. Dialysis malnutrition score with some features SGA-DMS score in over-60 year-old patients, dialysis over five years, anorexia status, are statistically higher than other patients. 3.3.2.3. Dietary energy and protein intake with some features DEI and DPI in patients over 60 years old, diabetes mellitus, and loss appetite are statistically less than in patients under 60 years old, non-diabetic etiology, and healthy appetite status. 3.3.2.4. Biochemical parameters with some features The concentration of serum albumin, prealbumin in patients over 60 years old, diabetes, anorexia, and hsCRP over 5 mg/l were significantly lower than that of the other patients. 3.3.2.5. Multivariate logistic regression analysis Multivariate analysis results showed an independent relationship between patients over 60 years old (OR=3.11; 95%CI: 0.08-0.37; p<0.05) with PEW criteria according to ISRNM 2008. 3.3.3. Initial results of oral nutritional supplementation on nutrition status in hemodialysis patients 3.3.3.1. General characteristics of the intervention and control group at baseline The gender distribution, mean age, and duration of dialysis, causes of CKD at baseline (T0) in the intervention group were similar to the control group. The difference was not statistically significant with p>0.05. 3.3.3.2. Characteristic of nutrition indicators in the intervention and control group at baseline Most indicators of nutritional status at baseline (T0) in both groups did not have statistically significant differences with p>0.05. 3.3.3.3. Results of dietary supplementation to body mass index After 12 weeks of study, BMI did not differ in two groups with p>0.05. In the intervention group, the BMI increased significantly after 12 weeks of study with p<0.001. Meanwhile, there was no statistically significant change in the control group. Table 3.3. The changes in BMI of intervention and control group at baseline and after 12 weeks of the study BMI Intervention (n=39) Control (n=40) T0 T12 T0 T12 n % n % n % n % <18.5 17 43.6 10 25.6 13 32.5 12 30.0 ≥18.5 22 56.4 29 74.4 27 67.5 28 70.0 p 0.016 - In the intervention group, at the beginning of the study, 43.6% of patients had malnutrition status, and this prevalence statistically significantly decreased to 25.6% after a supplementation diet. The change was not significant in the control group with p>0.05. 3.3.3.4. Results of dietary supplementation to dialysis malnutrition score At T12, SGA-DMS in the intervention group was significantly lower than in the control group with p<0.05. SGA-DMS decreased significantly at T12 compared to baseline (T0). While in the control group, the change was not significant between two times. Table 3.4. The changes SGA-DMS of the intervention and control group at baseline and after 12 weeks of the study SGA-DMS Intervention (n=39) Control (n=40) T0 T12 T0 T12 n % n % n % n % 7-10 5 12.8 5 12.8 2 5.0 4 10.0 11-35 34 87.2 34 87.2 38 95.0 36 90.0 p - 0.50 In the intervention group, after 12 weeks of supplementation, this conversion was not statistically significant. In the control group, these changes were also not statistically significant. 3.3.3.5. Results of dietary supplementation to biochemical indicators Table 3.5. Changes some biochemical indicators of the intervention and control group at baseline and after 12 weeks of the study Variables Intervention (n=39) Control (n=40) T0 n (%) T12 n (%) T0 n (%) T12 n (%) sProtein, g/l < 66 4 (10.3) 2 (5.1) 6 (15.0) 4 (10.0) ≥ 66 35 (89.7) 37 (94.9) 34 (85.0) 36 (90.0) p 0.687 0.625 sAlbumin, g/l <40 31 (79.5) 24 (61.5) 24 (60.0) 24 (60.0) ≥40 8 (20.5) 15 (38.5) 16 (40.0) 16 (40.0) p 0,039 - sCholesterol, mmol/l ≤ 3.9 28 (71.8) 20 (51.3) 26 (65.0) 23 (57.5) >3.9 11 (28.2) 19 (48.7) 14 (35.0) 17 (42.5) p 0.021 0.549 There was no difference between the two groups at T0 and T12. In the intervention group, the concentration of serum protein, albumin, and total cholesterol increased significantly after 12 weeks of supplementation compared to the T0. In the control group, the changes in the above nutritional indicators were not statistically significant at T12. The concentration of serum protein in the two groups has no significant difference. The prevalence of malnutrition in the intervention group, according to albumin criteria, decreased significantly from 79.5% (at baseline) to 61.5% (T12) of patients while there was no change in the control group. The prevalence of malnutrition in the intervention group, according to total cholesterol criteria, decreased significantly from 71.8% (at baseline) to 51.3% (T12). There was also no change in the control group. 3.3.3.6. Results of dietary supplementation to hematological indicators There was no difference between the two groups at baseline and T12. In both groups, the count of RBC and hemoglobin concentration did not differ between the two times. In the intervention group, 87.2% of patients with low RBC at baseline decreased to 76.9% at T12 while in the control group from 90% to 87.5% of patients. These changes in both groups were not statistically significant. Similarly, the changes in blood hemoglobin concentration in both groups were also no significant differences. CHAPTER 4 DISCUSSION 4.1. GENERAL CHARACTERISTICS OF STUDY SUBJECTS Regarding gender, 62.4% of the patients were male, 1.66 times more than female. The mean age was 53.0 ± 14.6 years old, most of whom belonged to patients under 65 years (73.4%). Chronic kidney disease due to chronic glomerulonephritis accounts for the highest proportion with 57.2% of patients, while diabetes mellitus and hypertension are common causes in most studies of foreign authors. This ratio is consistent with the characteristics of the primary cause of CKD in the epidemiological statistic in Vietnam and other developed countries in the world. Regarding the duration of dialysis, the study subjects were mainly in the under-five years' dialysis group (77.4%). There were 45.7% of infected hepatitis B and C virus patients. The prevalence of loss appetite status was 78.0% of patients. The mean DEI and DPI in this study were low and did not reach the recommended by NKF/DOQI 2000, respectively 24.9 ± 4.2 kcal/kg/day, 0.95 ± 0.17 g/kg/day. The prevalence of patients who did not meet both DEI and DPI requirements is very high (93.1%). 4.2. NUTRITIONAL STATUS OF STUDY SUBJECTS 4.2.1. Anthropometric measurements The malnutrition rate, according to BMI, TSF, MAC, MAMC, AMA criteria, accounted for about 1/3 of the patients (34.7%), 11.0%, 30.6%, 15.6%, and 59.5%, respectively. The mean of these measurements are worse than those of other authors in the world. This may be because Vietnamese people are in countries with the lowest physical status in the world. Besides, the cause of CKD in this study is mainly due to chronic glomerulonephritis, the disease begins from young ages, thus adversely affecting the nutritional status of patients. 4.2.2. SGA-DMS The prevalence of malnutrition, according to SGA-DMS criteria, was very high, accounting for 85.5% of patients, which is mainly mild-moderate malnutrition (77.5%). This result is similar to the outcomes of other studies in the world. 4.2.3. Laboratory parameters The incidences of malnourished patients, according to the concentration of serum albumin and prealbumin, were relatively high, about 2/3 (67.6%) and 57.6%, respectively. The decrease in visceral protein concentration may be due to the influence of anorexia, leading to decreased DEI and DPI, the effects of inflammation, diabetes etiology, advanced age The percentage of low red blood cells and hemoglobin level were high, 89.0% and 91.3% of patients. This is probably because kidney disease itself causes a lack of erythropoietin, poor diet, the environment of uremia toxin, gastrointestinal bleeding. 4.2.4. PEW according to ISRNM 2008 The prevalence of PEW in our study was 24.3% of patients (at least 3 out of 4 criteria included BMI, AMA, DPI, and serum albumin). 4.3. RELATIONSHIP BETWEEN NUTRITION INDICATORS WITH CLINICAL, LABORATORY FEATURES, AND THE INITIAL RESULT OF AN ORAL NUTRITIONAL SUPPLEMENT ON NUTRITIONAL STATUS IN HEMODIALYSIS PATIENTS 4.3.1. Correlation between nutritional indicators SGA-DMS score was inversely correlated with BMI, DEI, DPI, and serum albumin, prealbumin. This shows that SGA-DMS is very valuable when compared to other indicators. Meanwhile, DEI and DPI were positively correlated with each other and with serum albumin, prealbumin, and BMI. This shows that when patients have low dietary energy and protein intake, the risk of BMI, serum albumin, and prealbumin is also low. The BMI was positively associated with serum albumin, but not with serum prealbumin. 4.3.2. Relationship between indicators of nutritional status and clinical, laboratory characteristics 4.3.2.1. Relationship between nutritional indicators with age Most of the nutritional indicators in patients over 60 years old were inferior compared to patients under 60 years old. When multivariate regression analysis of nutritional status with some clinical and laboratory characteristics, age was the only independent factor related to PEW. 4.3.2.2. Relationship between nutritional indicators with hemodialysis vintage Among the nutritional indicators, only the SGA-DMS score was related to the duration of dialysis of patients (patients on dialysis more than five years have points higher than less than five years). 4.3.2.3. Relationship between nutritional indicators with etiology of CKD DEI, DPI, serum albumin, and prealbumin levels tended to be significantly lower in diabetic patients compared to patients with other causes. 4.3.2.4. Relationship between nutritional indicators with appetite status Patients with anorexia status had lower DEI, DPI, serum albumin, and prealbumin levels, higher SGA-DMS scores when compared to those with normal appetite status. 4.3.2.5. Relationship between nutritional indicators with serum hsCRP The concentration of serum albumin and prealbumin in patients with high serum hsCRP levels was significantly lower than the low hsCRP levels of patients. 4.3.3. Initial results of oral nutritional supplementation on nutritional status in maintenance hemodialysis patients 4.3.3.1. General characteristics of intervention and control group Participants in both groups had similarities in general and nutritional characteristics at baseline of the study. 4.3.3.2 Results of dietary supplementation to body mass index The mean BMI increased significantly after 12 weeks of the study compared to baseline in the intervention group, while the change was not statistically significant in the control group. In the intervention group, 43.6% of malnutrition patients at baseline decreased significantly to 25.6% after 12 weeks of dietary supplementation. In contrast, there was no significant change in the control group. 4.3.3.3. Results of dietary supplementation to dialysis malnutrition score The mean SGA-DMS score after 12 weeks of study, in the intervention group, was significantly lower than the baseline and the control group. When analyzing the changes in the prevalence of malnutrition in both groups and at two times, the differences were not statistically significant. 4.3.3.4. Results of dietary supplementation to biochemical indicators Biochemical indicators: in the intervention group, the mean values of serum protein, albumin, and total cholesterol increased after 12 weeks of supplementation compared to baseline, while the control group did not have any significant changes. The prevalence of malnutrition in serum albumin concentration in the intervention group at baseline was 79.5%, reduced significantly to 61.5% of patients aft