NIED Study

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NIED Study
Nutritional and Inflammatory Evaluation of Dialysis Patients
www.NIEDStudy.org

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        Over 250,000 maintenance hemodialysis (MHD) patients in the United States have an increased rate of protein-energy malnutrition (PEM) and inflammation, together also known as “Malnutrition-Inflammation Complex Syndrome” (MICS), which are felt to be major risk factors for their high morbidity and mortality and low quality of life (QoL). The risk of cardiovascular death appears to be especially high among these individuals. This impact is so overwhelming that it may be responsible for the reversal of the associations between conventional cardiovascular risk factors and outcome in MHD patients, a phenomenon also known as “Reverse Epidemiology”. To date, there is no uniform, practical tool for the assessment of nutritional status, inflammation or food intake in dialysis patients.

        The goals of this prospective cohort study are to determine whether the nutritional and inflammatory states in dialysis population affect the mortality, morbidity, and other clinical outcomes in a predictable way and to ascertain how the deterioration of these indices over time is associated with poor outcome. To achieve these goals, we will study a dynamic cohort of 360 prevalent MHD patients at DaVita dialysis units in Los Angeles area prospectively. The ongoing recruitment to replace subject losses over time will form a non-concurrent cohort which will have approximately 900 MHD patients within a 5-year interval. Nutritional and inflammatory assessments will be performed periodically including biochemical markers, anthropometry, Subjective Global Assessment of nutrition (SGA), and near-infrared interactance. Clinical outcomes (mortality, hospitalization, quality of life, and anemia and iron indices) will be assessed longitudinally. A convenient but reliable nutritional-inflammatory scoring system (currently known as “Malnutrition-Inflammation Score” or MIS) to predict the mortality and clinical outcome in the dialysis population will be developed and validated. A subcohort of MHD patients will be selected for additional studies including DEXA, bio-electrical impedance analysis, and food records at the General Clinical Research Center (GCRC) at Harbor-UCLA campus.

        The following specific questions will be answered:
1) Are the dialysis mortality and risk of cardiovascular death associated with malnutrition or inflammation?
2) Do PEM and/or inflammation and their deterioration over time have measurable, distinct impact on relevant clinical outcomes in MHD patients such as hospitalization, QoL and erythropoietin resistance?
3) Can a numerical result of a uniform nutritional scoring system (such as MIS) be a reliable predictor of dialysis morbidity and mortality?
4) Can a food questionnaire reliably detect deficient nutrient intake in dialysis patients?

The PI is Kamyar Kalantar-Zadeh, MD, MPH (Harbor-UCLA). The sponsors are Joel D. Kopple, MD, (Harbor-UCLA); Gladys Block, PhD, (UC Berkeley); and Michael H. Humphreys, MD (UCSF). The Statistical Consultant is David Gjertson, PhD (Harbor-UCLA). The collaborator is Charles J McAllister, MD (DaVita, Inc). The study center is Harbor-UCLA campus. The Harbor-UCLA GCRC facilities are applied to this research project, and DaVita dialysis units including at Harbor-UCLA/MFI and in the Los Angeles area provide uniform patient profile and standardized laboratory results.

KEY PERSONNEL:

Name	Organization	Role on Project
Kamyar Kalantar-Zadeh, MD, MPH	Harbor-UCLA, Nephrology	Principal Investigator
Joel D. Kopple, MD	Harbor-UCLA, Nephrology	Sponsor
Mike. H. Humphreys, MD	UCSF, Nephrology	Co-sponsor
Gladys Block, PhD	UC Berkeley, Epidemiology	Co-sponsor
Charles J McAllister, MD	DaVita, Inc	Collaborator
David Gjertson, PhD	UCLA Biostatistics	Consultant