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1 ABSTRACT Chronic kidney disease (CKD) has an increasing incidence The annual incidence and prevalence of CKD using kidney replacement methods are increasing, reflecting advances in the treatment of this disease Malnutrition is common in patients with CKD with and without kidney replacement methods Malnourished and CKD interact with each other to increase morbidity, reduce the quality of life, prolong hospital stay, increase treatment costs, and mortality in this population Malnutrition in CKD patients has more than one factor alone Present, diagnostic of malnutrition in this object does not have a “gold standard” However, a list of signs and indicators to assess and diagnose malnutrition status can be used, including assessments on a diet, anthropometric measurements, laboratory parameters, and other tools Diagnostic of malnutrition status is necessary for selecting nutritional supplements for patients to solve the above issues In Vietnam, there were some studies on evaluating nutritional status, but there has not been any comprehensive research on the issue of nurturing for CKD patients To contribute to further clarifying this problem, we proceed to the thesis: “A study on nutritional status, the results of an oral nutritional supplement on maintenance hemodialysis patients.” with two objectives: To investigate of nutritional status in maintenance hemodialysis patients by indicators: anthropometric, dietary energy, and protein intake, dialysis malnutrition score, serum albumin, prealbumin levels 2 To Understand the relationship between nutritional status and some clinical and laboratory characteristics, initially assessing the results of an oral nutritional supplement on nutritional status in 12 weeks in maintenance hemodialysis patients Summary of new main scientific contributions of the thesis: Determine the malnutrition rate as well as some factors affecting nutritional status in hemodialysis patients Besides, initially evaluating the results of oral dietary supplements for 12 consecutive weeks in this subject This thesis will contribute to clinical practice and propose solutions to improve nutritional status for malnourished patients Thesis layout: The thesis consists of 125 pages, including sections and four chapters: Introduction 02 pages; Literature Review 33 pages; Methodology 25 pages; Results 26 pages; Discussion 36 pages; Conclusions 02 pages; Recommendations 01 page Refer to 150 documents (141 English, 11 Vietnamese) ABBREVIATIONS AMA: Upper Arm muscle area MAC: Mid-upper arm BMI: Body mass index circumference CKD: Chronic kidney disease MAMC: Mid-upper arm muscle DEI: Dietary Energy Intake circumference DPI: Dietary Protein Intake PEW: Protein Energy Wasting HBV: High Biological value RBC: Red blood cell ISRNM: International Society SGA-DMS: Subjective Global of Renal Nutrition & AssessmentDialysis Metabolism Malnutrition score K/DOQI: Kidney /disease TSF: Triceps Skinfold outcomes quality initiative CHAPTER LITERATURE REVIEW 1.1 A BRIEF HISTORY OF CHRONIC KIDNEY DISEASE According to the K/DOQI 2002, CKD is defined as having kidney damage or glomerular filtration rate below 60 ml/min/1.73 m2 of at least three months In 2002, the KDIGO gave a similar but more concise definition CKD is an abnormality in kidney structure and function that lasts more than three months, and effects on patient health CKD is categorized 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 4 1.2 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 5 - 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 6 CHAPTER 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, 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, SGADMS, 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 8 - 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 to The total score ranges from 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 (2235 points) 9 - 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 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 10 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 11 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 Weight, kg Prevalence % - 51.5 ± 9.1 < 16 5.2 BMI, 16-18,5 51 29.5 kg/m 18,5-24,9 107 61.8 ≥ 25 3.5 X ± SD 19.7 ± 2.6 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 % 7-10 25 14.5 11-21 134 77.5 22-35 14 8.1 X ± SD 15.2 ± 4.3 12 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 BMI DEI DPI (score) (kg/m2) (kcal/kg/day) (g/kg/day) r r r BMI -0,22 p 0,004e r p p p sAlbumin (g/l) r p 13 DEI -0,47
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