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SECTION I USE OF THE CLINICAL PRACTICE GUIDELINE, This Clinical Practice Guideline document is based upon the best information available as of. April 2017 It is designed to provide information and assist decision making It is not intended. to define a standard of care and should not be construed as one nor should it be interpreted as. prescribing an exclusive course of management Variations in practice will inevitably and. appropriately occur when clinicians take into account the needs of individual patients available. resources and limitations unique to an institution or type of practice Every health care. professional making use of these recommendations is responsible for evaluating the. appropriateness of applying them in the setting of any particular clinical situation The. recommendations for research contained within this document are general and do not imply a. specific protocol, Commissioned evidence review included articles published through April 2017 Consensus. opinion statements use literature published though August 2018. SECTION II DISCLOSURE, Kidney Disease Outcomes Quality Initiative KDOQI and American Academy of Nutrition and. Dietetics AND make every effort to avoid any actual or reasonably perceived conflicts of. interest that may arise as a result of an outside relationship or a personal professional or. business interest of a member of the Work Group All members of the Work Group are required to. complete sign and submit a disclosure and attestation form showing all such relationships that. might be perceived or actual conflicts of interest All reported information will be printed. in the final publication and are on file at the National Kidney Foundation NKF. Guideline on Nutrition in CKD Page 2,TABLE OF CONTENTS. Table of Tables 4,Table of Figures 4,Abbreviations and Acronyms 5. Work Group Membership 8,Organization Leadership 9,Abstract NA. Foreword NA,Methods 10,Summary of Guideline Statements 25. Guideline 1 Assessment 36,1 0 Usual Care Statements 36. 1 1 Technical Devices Anthropometric Measurements to Measure Body Composition 36. 1 2 Laboratory Measures of Body Composition 50,1 3 Handgrip Strength 57. 1 4 Methods to Assess Energy Requirements 59, 1 5 Composite Nutritional Indices to Measure Nutritional Status in CKD Patients 62. 1 6 Tools Methods Used to Assess Protein Intake and Calorie Intake 71. Guideline 2 Medical Nutrition Therapy 74,Guideline 3 Dietary Protein and Energy Intake 82. 3 0 Energy Intake 82,3 1 Protein Amount 82,3 2 Protein Type 94. 3 3 Dietary patterns Fruits and Vegetables Mediterranean 98. Guideline 4 Nutritional Supplementation 103, 4 1 Nutrition Supplementation Oral Enteral and Parental Nutrition 103. 4 2 Nutrition Supplementation Dialysate 115, 4 3 Long Chain Omega 3 Polyunsaturated Fatty Acids 119. Guideline 5 Micronutrients 128,5 0 General Guidance 128. 5 1 Folic acid with and without other B Vitamins 132. 5 2 Vitamin C 137,5 3 Vitamin D 142,5 4 Vitamin E and A 148. 5 5 Vitamin K 155,5 6 Selenium and Zinc 159,Guideline 6 Electrolytes 164. 6 1 Acid Base 164,6 2 Calcium 171,6 3 Phosphorus 175. 6 4 Potassium 184,6 5 Sodium 188,Biographic and Disclosure Information 196. References 206,Guideline on Nutrition in CKD Page 3. Table 1 Key Questions for Evidence Review 16, Table 2 Evidence Review Inclusion and Exclusion Criteria 18. Table 3 Quality of Evidence Grades 24, Table 4 Implications of strong and weak recommendations for different users of guidelines 25. Figure 1 Flow diagram of identified studies for Assessment questions 21. Figure 2 Flow diagram of identified studies for Intervention questions 22. Guideline on Nutrition in CKD Page 4,ABBREVIATIONS AND ACRONYMS. ACE Angiotensin converting enzyme inhibitors,APD Animal based Protein Diet. AND Academy of Nutrition and Dietetics,ARB Angiotensin II receptor blocker. BF Body fat,BIA Bio electrical impedance analysis,BMI Body mass index. BP Blood pressure,BPI Body protein index,CAPD Continuous ambulatory peritoneal dialysis. CIMT Constraint induced movement therapy,CK Creatinine kinase. CKD Chronic kidney disease,CRP C reactive protein,CVD Cardiovascular disease. DBP Diastolic blood pressure,DEXA Dual energy X ray absorptiometry. eGFR Estimated glomerular filtration rate,EAAs Essential amino acids. ESRD End stage renal disease,FM Fat mass,FFM Fat free mass. FSA Four site skinfold anthropometry,GFR Glomerular filtration rate. GNRI Geriatric Nutrition Risk Index, GRADE Grades of Recommendation Assessment Development and Evaluation. HD Hemodialysis,HDL C High density lipoprotein cholesterol. HGS Handgrip Strength, HOMA IR Homeostatic Model Assessment of Insulin Resistance. HR Hazard ratio,hsCRP High sensitivity C reactive protein. IBW Ideal body weight,IDPN Intradialytic parenteral nutrition. IL 6 Interleukin,IMT Intima media thickening,IV Intravenous. Guideline on Nutrition in CKD Page 5,KA Ketoacid,KAA Ketoacid analogue. KDIGO Kidney Disease Improving Global Outcomes, KDQOL SF Kidney disease quality of life short form. KDOQI Kidney Disease Outcomes Quality Initiative,KQ Key question. LBM Lean body mass,LDL C Low density lipoprotein cholesterol. LPD Low protein diet,MAMC Mid arm muscle circumference. MF BIA Multi frequency bio electrical impedance analysis. MGP Matrix Gla protein,MHD Maintenance hemodialysis. MHDE Maintenance Hemodialysis Equation,MIS Malnutrition Inflammation Score. MNA Mini nutrition assessment,MNA SF Mini Nutrition Assessment Short Form. MST Malnutrition Screening Tool,MUST Malnutrition Universal Screening Tool. NEAAs Non essential amino acids,NEAP Net endogenous acid production. NHANES National Health and Nutrition Examination Survey. NIS Nutrition Impact Symptoms NKF,National Kidney Foundation. NRCT Non randomized controlled trial,nPCR Normalized protein catabolic rate. nPNA Normalized protein nitrogen appearance,NST Nutrition Screening Tool. ONS Oral nutritional supplements,PCR Protein catabolic diet. PD Peritoneal dialysis,PEW Protein energy wasting,PNA Protein nitrogen appearance. PNI Protein Nutrition Index,RCTs Randomized controlled trials. RDN Registered dietitian nutritionist,REE Resting energy expenditure. R NST Renal Nutrition Screening Tool,RRT Renal Replacement Therapy. Guideline on Nutrition in CKD Page 6,SBP Systolic blood pressure. SGA Subjective Global Assessment,SKF Skinfold thickness. SR Systematic review,TBF Total body fat,TG Triglycerides. TNF a Tumor Necrosis Factor alpha,TSF Triceps skinfold thickness. VPD Vegetable proteindiet,VLPD Very low protein diet. Guideline on Nutrition in CKD Page 7,WORK GROUP MEMBERSHIP. Work Group Co Chairs,T Alp Ikizler MD Lilian Cuppari PhD. Vanderbilt University Medical Center Oswaldo Ramos Foundation Hrim. Nashville TN USA Federal University of Sao Paulo,S o Paulo Brazil. Work Group, Jerrilynn Burrowes PhD RD CDN Laura Byham Gray PhD RD CDN. Long Island University Brookville Rutgers University. NY USA Newark NJ USA, Katrina Campbell PhD Juan Jesus Carrero Pharm PhD Pharm PhD Med. Bond University Karolinska Institutet,Robina Queensland Australia Stockholm Sweden. Winnie Chan PhD RD Denis Fouque MD PhD, Queen Elizabeth Hospital Birmingham University Claude Bernard Lyon. Birmingham United Kingdom Lyon France,Allon Friedman MD FASN Sana Ghaddar PhD RDN. Indiana University Carmel DaVita,Indianapolis IN USA San Francisco CA USA. Jordi Goldstein Fuchs DSc APRN C RD George Kaysen MD PhD. Sierra Nevada Nephrology Consultants University of California Davis. Reno NV USA Davis CA USA,Joel Kopple MD Daniel Teta MD PhD. Lundquist Institute for Biomedical Innovation at Lausanne University. Harbor UCLA Medical Center and UCLA Lausanne Switzerland. Torrance CA USA,Angela Yee Moon Wang MD PhD,University of Hong Kong. Evidence Review Team,Deepa Handu PhD RD LDN Mary Rozga PhD RDN. Academy of Nutrition and Dietetics Academy of Nutrition and Dietetics. Chicago IL USA Chicago IL USA,Guideline on Nutrition in CKD Page 8. KDOQI and Academy Guideline Development Staff,Kerry Willis PhD Jessica Joseph MBA. National Kidney Foundation National Kidney Foundation. New York NY New York NY,Laura Brereton MSc Tom Manley RN BSN. National Kidney Foundation National Kidney Foundation. New York NY New York NY,Alison Steiber PhD RDN Mary Rozga PhD RDN. Academy of Nutrition and Dietetics Academy of Nutrition and Dietetics. Chicago IL USA Chicago IL USA,Deepa Handu PhD RDN LDN. Academy of Nutrition and Dietetics,Chicago IL USA,Organizational Leadership. Academy of Nutrition and Dietetics KDOQI,Alison Steiber PhD RDN Michael Rocco MD MSCE. Chief Science Officer KDOQI Chair,Holly Kramer MD,Vice Chair Research. President National Kidney Foundation,Bernard Jaar MD MPH. Vice Chair Education,Michael J Choi MD,Vice Chair Policy. Past President National Kidney Foundation,Guideline on Nutrition in CKD Page 9. The Guideline Development Process, According to the Institute of Medicine National Academy of Sciences Clinical practice. guidelines are statements that include recommendations intended to optimize patient care that. are informed by a systematic review of evidence and an assessment of the benefits and harms. of alternative care options This chapter describes the process and methods used to conduct. comprehensives systematic reviews and how the findings from these systematic reviews were. used to develop clinical practice nutrition guidelines for patients with chronic kidney disease. These guidelines were developed according to the Standards for Developing Trustworthy. Clinical Practice Guidelines as stated by Institute of Medicine. Development of these guidelines was a collaborative process between National Kidney. Foundation NKF and the Academy of Nutrition and Dietetics Academy Nutrition and its. management are an integral aspect of care for patients with kidney disease Due to recent. developments in the literature regarding treatment and assessment of CKD the Academy and. NKF collaborated to merge update and expand the current 2010 Evidence Analysis Library. EAL CKD guidelines and the Kidney Disease Outcomes Quality Initiative KDOQI. Nutrition Guidelines Hence the objective of this initiative is to provide medical nutrition. therapy MNT guidelines for patients with chronic kidney disease CKD to assess prevent. and treat protein energy wasting mineral and electrolyte disorders and other metabolic co. morbidities associated with CKD, Overview of the guideline development process Guideline development is a detailed and. comprehensive process The steps followed to develop this guideline are below some steps. were completed concurrently, 1 Select the Work group or expert panel that works with the evidence review team. 2 Orient the work group the 5 step systematic review process of the Academy of. Nutrition and Dietetics Evidence Analysis Center, 3 Develop research questions inclusion and exclusion criteria and a detailed search plan. as well as identify interventions and outcomes of interest. Guideline on Nutrition in CKD Page 10,4 Search multiple databases based on search plan. 5 Screen abstracts and full text articles based on a priori eligibility criteria. 6 Extract data and critically assess the quality of included studies risk of bias of studies. 7 Synthesize evidence narratively evidence summary and conclusion statements and in. table format Study characteristics and findings table Grade the quality of evidence for. each outcome and provide GRADE tables, 8 Develop recommendation statements based on the findings of the systematic review. and other important considerations and assign strength of recommendation. 9 Write a guideline manuscript, 10 Conduct internal external and public review of the guideline. 11 Respond to reviewer comments and update the guideline before publication. Work group selection process The Academy of Nutrition and Dietetics led the process of work. group member recruitment To assure appropriate expertise and limit bias the Evidence Based. Practice Committee Work Group Selection sub committee followed a transparent process of. selecting work group members An open recruitment message with a link to online application. was circulated via stakeholders for experts in the topic area of chronic kidney disease. Interested candidates provided signed Disclosure and Conflict of Interest From curriculum. vitae and personal statements indicating interest and qualifications that related to the topic. The workgroup selection committee then evaluated each candidate based on set criteria. Higher scoring candidates were considered for position of workgroup chair co chair A total. of 15 workgroup members were selected to develop these guidelines Two co chairs were. appointed and the work group consisted of physicians registered dietitians or nutritionists. researchers and methodologists with expertise in the renal nutrition field The selected. members according to their experiences and skill sets were assigned to corresponding. subtopics The work group participated in all steps of systematic review process which. included developing research questions agreeing on inclusion and exclusive criteria. developing the search plan evaluating the evidence and approving and grading the evidence. and developing recommendation statements All workgroup members and the evidence review. team ERT met twice for 2 day face to face meetings as well as a teleconference calls once a. month for the duration of the project,Guideline on Nutrition in CKD Page 11. Guideline focus During the first meeting the work group defined the scope for the guideline. The co chairs developed the first draft of the scope which was discussed and refined by the. work group members It was determined that the guideline would focus on Nutrition in all. stages of CKD in adults and would cover the subtopics of macronutrient micronutrient and. electrolyte management in CKD Both assessment and intervention question under these. subtopics were proposed Three workgroups were developed with five members assigned to. each workgroup and a Chair appointed to help lead the workgroup. Systematic review process Question development literature search and study selection This. guideline followed the Academy of Nutrition and Dietetics systematic review methodology. An analytical framework was developed by the ERT and refined by the work group. members to help guide question development During the initial teleconference calls and. first face to face meeting the workgroup developed a list of questions that were deemed. important for clinicians and patients Table 1 The workgroup developed the a priori inclusion. and exclusion criteria as listed in Table 2, A comprehensive search of literature was conducted using PubMed MEDLINE EMBASE. and CINAHL search engines A first literature search was conducted to identify studies. addressing assessment questions and a second search was conducted to identify studies. addressing intervention questions in order to identify studies that answered more than one. question Inclusion criteria included in the search plan included human adults with CKD aged. 19 years and older published between 1985 and December 2016 hu Search terms included. terms to identify relevant nutrition interventions assessment tools in adult CKD patients. The first literature search focused on assessment questions identified 4 857 potential studies. The PRISMA diagram illustrating the study selection process are presented in Figure 1 The. second comprehensive search to answer all the intervention questions in order identified. 11 017 potential studies The PRISMA diagram illustrating study selection process for. intervention questions is in Figure 2,Guideline on Nutrition in CKD Page 12. After the search was completed studies were systematically screened based additional a priori. inclusion exclusion criteria For intervention questions only randomized controlled trials that. had at least 6 individuals per arm were included Included studies investigated an intervention. of interest e g protein restrictions phosphorus intake sodium intake etc in comparison with. no intervention or minimal intervention For assessment questions only studies that tested the. validity reliability or relationship of an assessment tool against a comparative tool reference. standard or mortality were included in this review. The list of titles and abstracts were independently reviewed and marked for inclusion or. exclusion along with the reason and any differences were resolved by discussion with a third. reviewer Full texts of articles meeting inclusion criteria were ordered and reviewed for. inclusion 225 studies met the inclusion criteria for Intervention questions and 125 for. assessment articles A list of excluded articles with reason for exclusion was also created to. maintain transparency available of Academy of Nutrition and Dietetics Evidence Analysis. Center website, Data extraction and study quality assessment Relevant data was extracted from the included. articles using a standardized online data extraction tool Key information extracted from each. study included Authors information year of publication type of study design details of. intervention type of intervention duration of the intervention who delivered the intervention. setting number of centers Participants sample size mean age age range gender study. inclusion and exclusion criteria comorbidities Interventions intervention details comparison. group details medication use Outcomes reported primary and secondary outcomes time. points of reported outcomes other details such as funding source. All included studies were critically appraised for risk of bias Two independent reviewers. assessed the quality or studies using the Academy s online risk of bias tool the Quality Criteria. Checklist QCC The questions of the QCC are based on quality constructs and risk of bias. domains identified by the Cochrane Collaboration and the Agency for Healthcare Research ad. Quality AHRQ Questions examine sampling bias performance bias detection bias attrition. Guideline on Nutrition in CKD Page 13, bias and reporting bias Any discrepancies between the two reviewers were resolved by. consensus or by a third reviewer, Data synthesis and grading the evidence Descriptive synthesis of evidence was conducted for. all identified outcomes for which there were included studies When possible meta analysis. was conducted using random effects model For continuous data results were summarized as. mean difference MD between treatment groups intervention v s control placebo with 95. confidence interval CI or standardized mean differences SMD Dichotomous outcomes. were reported as odds ratio OR or risk ratios RR with 95 CI The I2 statistic was used to. determine the degree of heterogeneity in the calculated effect size and 25 50 and 75. were considered low moderate high respectively Sub group analysis was conducted as. appropriate to manage clinical heterogeneity, After completion of the data extraction and data synthesis the ERT provided the systematic. review results in the following formats for the workgroup to review edit and approve 1. Evidence summary a narrative summary of all included trials for each identified outcome was. drafted for each research question in the systematic review A conclusion statement was. developed for each proposed question outcome The conclusion statement is a clear simple. and to the point answer to the proposed questions 2 Study characteristics table provided. information regarding study characteristics sample size population intervention details and. quality of each included study 3 Quality of evidence strength of evidence Each of the. conclusion statements were assigned a GRADE reference to reflect the quality of studies. inconsistency of results imprecision indirectness of the evidence and publication bias Using. this method the evidence for each outcome of interest was graded as A high B moderate C. low or D very low A GRADE table was generated using GradePro and demonstrated how. the strength of evidence GRADE was derived for each outcome of interest. Guideline development The workgroup members drafted comprehensive recommendations for. nutrition care for adults with CKD During this phase the role of the work group member was. to translate the available evidence into action statements that were clear concise and ready to. Guideline on Nutrition in CKD Page 14, be implemented by practitioners The workgroup and ERT used the GRADE method for. development of recommendations The GRADE method involves two major components a. rating for quality of evidence described above and rating the strength of recommendations. The evidence grades are reported at the end of the recommendation statements e g A B C or. D and reflect the confidence in the estimated effects Table 3. The second component is rating the strength of the recommendation statement This rating. reflects the extent to which one is confident that desirable effects of an intervention outweigh. undesirable effects The grade for strength of the recommendation can be assigned Level 1 or. Level 2 Table 4 shows the implication of each level for practitioners clinicians and policy. makers Level 1 recommendations use the terminology We recommend which means that. this course of action should be applied to most people and practitioners can have confidence. that implementing this recommendation has more benefit than risk Level 2 recommendations. use the terminology We suggest, When providing the level for the strength of the recommendation a number of factors besides. the quality of evidence are taken into consideration including patient values and preferences. quality of evidence benefits and harms cost resources to implement the recommendation. acceptability feasibility and health equity In addition to evidence based recommendations in. certain scenarios Opinion statements were developed These statements were developed. when there was not enough evidence or evidence had too low of quality to write a graded. recommendation but the workgroup determined it was important to provide some guidance to. patients and practitioners These recommendations are ungraded and usually refer to general. or routine practice, Once the full draft of recommendation statements was ready it was reviewed and edited. multiple times by all the workgroup members and the ERT The workgroup participated in a. final blinded vote of recommendation statements and a majority of votes approving the. statement was necessary for each statement to be accepted into the final guideline.
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