Preliminary Results of the NIED Study

 

Although NIED Study is only halfway through, some clinically relevant findings based on the analyses of the data from the first 12 to 30 months of the study have led to following publications and reports:

 

(A) Protein Intake and Outcome in High Kt/V [1]: In 122 MHD patients with a delivered Kt/Vsp>1.20, independent of their residual renal function, the nPNA and Kt/Vsp did not correlate significantly (r=0.09) except when analysis was limited to Kt/V values <1.5 (r=0.54). Both nPNA and serum albumin predicted prospective hospitalization and mortality in MHD patients with Kt/V > 1.20.

 

(B) Erythropoietin Hypo-responsiveness [2]: Elements of MICS including a high MIS value and increased serum levels of inflammatory markers (CRP, IL-6, and TNF-α), and decreased serum levels of nutritional values (total cholesterol, prealbumin and TIBC) correlated with EPO hypo-responsiveness in MHD patients of NIED Study.

 

(C) Significance of Appetite in MHD Patients [3]: Anorexia was found to be associated with increased levels of pro-inflammatory cytokines, a worse MIS score, refractory anemia, and poor clinical outcome including a 4-fold increase in mortality, higher hospitalization rates, and a poor QoL in MHD patients.

 

(D) Reverse Epidemiology of Homocysteine [4]: The associations between total homocysteine (thcys) level and markers of MICS and 12-month prospective hospitalization and mortality in 367 MHD patients of the NIED cohort was examined; 94% of MHD patients had hyperhomocysteinemia (thcys>13.5 µmol/L). Thcys had statistically significant correlations with some markers of nutrition but not with serum CRP, IL-6 or TNF-α. Mortality and hospitalization rates were significantly higher in patients with lower thcys levels. The lowest thcys quartile conferred a 2-fold increase in risk of death independent of hypoalbuminemia.

 

(E) Comparing Outcome-Predictability of Markers of MICS [5]: The association of 10 markers of MICS with prospective mortality and hospitalization in 378 MHD patients of the NIED Study cohort was examined. The magnitude of relative risk of death and hospitalization was greatest for MIS, CRP and IL-6. In extended multivariate models that included all 10 MICS markers and 11 additional covariates simultaneously, CRP and MIS were the only consistent predictors of mortality and hospitalization, and their outcome-predictability was superior to serum albumin. Among case-mix covariates, Charlson comorbidity index was the only statistically significant outcome-predictor in all models.

 

(F) Reverse Epidemiology of Serum Iron: [6]: In a large cohort of 1,283 MHD patients from 10 DaVita dialysis facilities, mortality was significantly greater in the lowest serum iron quartile. Multivariate Poisson and Cox models adjusted for relevant covariates including administered EPO and iron doses showed that both serum iron level and iron saturation ratio had significant but inverse associations with prospective mortality and hospitalization. This reverse association remained significant in a sub-cohort of 322 MHD patients of the NIED Study after additional adjustments for comorbid conditions and serum CRP to reflect inflammation.

 

(G) Outcome-Predictability of Peripheral Lymphocyte Percentage [7]: The associations of the baseline white blood cell count (WBC) and lymphocyte percentage (LYM%) with 12-month mortality and three measures of hospitalization in a cohort of 1,283 MHD patients from 10 outpatient DaVita dialysis clinics in Los Angeles County, as well as in a sub-cohort of 372 MHD patients (NIED Study) with additional measures of inflammation, nutrition and comorbidity. A high WBC and a low LYM% were associated with significant increase in mortality and hospitalization in MHD patients.

 

(E) Reverse Epidemiology of LDL Cholesterol [8]: An inverse J-shaped association has been found between serum LDL and prospective mortality in 629 MHD patients, even after controlling for CRP and other pertinent factors. Over a 2.5 year follow-up, lowest quartiles of LDL and total cholesterol had the highest all-cause and cardiovascular mortality (p<0.05). This paradoxical association may have significant clinical implications for the management of dyslipidemia in MHD patients.

 

(F) Serum Myeloperoxidase [9]: In 128 MHD patients serum myeloperoxidase (MPO) is correlated with serum IL1-β, ferritin and albumin. Serum MPO appears to be associated with some but not all markers of MICS.

 

(G) Markers of Lipoprotein Oxidation and Inflammation [10]: HDL inflammatory/anti-inflammatory properties (HIAP) was measured in sera of 188 MHD patients. Higher prevalence of pro-inflammatory HDL was observed in obese MHD patients, which may suggest that adipose tissue promote inflammation in obese MHD patients. Moreover, serum paraoxonase (PON), an esterase that inhibits the “oxidization of low-density lipoprotein” (LDLOX), was measured in 189 MHD patients, including 150 patients in whom PON was also measured simultaneously. PON was significantly but inversely correlated with serum CRP and serum IL-1 β. Similarly, LDLOX was significantly associated with CRP.

 

(H) Coronary Artery Calcification and MICS [11]: A higher serum ferritin, HDL-cholesterol and TNF-α and a worse anemia were associated with an increased risk of higher CAC scores in 85 MHD patients of the NIED Sub-study.

 

(I) Body Composition Assessment Comparison [12]: In 90 MHD patients who agreed to undergo tests of body composition in the NIED Sub-study, the BIA and TSF tend to overestimate while NIR tends to underestimate the body fat percentage when compared to DEXA as the reference standard. Both BIA and NIR had superior correlations with DEXA (r>0.85) compared to TSF based method. We concluded that both NIR and BIA are acceptable body composition tests. However, the NIR is a more patient- and evaluator-friendly method for outpatient dialysis units.

 

 

Reference:

1.         Kalantar-Zadeh K, Supasyndh O, Lehn RS, McAllister CJ, Kopple JD: Normalized protein nitrogen appearance is correlated with hospitalization and mortality in hemodialysis patients with Kt/V greater than 1.20. J Ren Nutr 13:15-25, 2003

2.         Kalantar-Zadeh K, McAllister CJ, Lehn RS, Lee GH, Nissenson AR, Kopple JD: Effect of malnutrition-inflammation complex syndrome on EPO hyporesponsiveness in maintenance hemodialysis patients. Am J Kidney Dis 42:761-773, 2003

3.         Kalantar-Zadeh K, Block G, McAllister CJ, Humphreys MH, Kopple JD: Appetite and inflammation, nutrition, anemia and clinical outcome in hemodialysis patients. Am J Clin Nutr, 2004 Aug [in-press]

4.         Kalantar-Zadeh K, Block G, Humphreys MH, McAllister CJ, Kopple JD: A low, rather than a high, total plasma homocysteine is an indicator of poor outcome in hemodialysis patients. J Am Soc Nephrol 15:442-453, 2004

5.         Kalantar-Zadeh K, Kopple JD, Humphreys MH, Block G: Comparing outcome predictability of markers of malnutrition-inflammation complex syndrome in haemodialysis patients. Nephrol Dial Transplant 19:1507-1519, 2004

6.         Kalantar-Zadeh K, McAllister CJ, Lehn RS, Liu E, Kopple JD: A low serum iron level is a predictor of poor outcome in hemodialysis patients. Am J Kidney Dis 43:671-684, 2004

7.         Kuwae N, Kopple J, Kalantar-Zadeh K: A low lymphocyte count is a predictor of mortality and hospitalization in hemodialysis patients. Clin Nephrology, 2004 [submitted]

8.         Kalantar-Zadeh K, Horwich TB, Fonarow GC, Anker SD, Kopple JD: A Low, rather than a high, serum LDL cholesterol is associated with increased mortality in hemodialysis patients even after controlling for inflammation. 37th annual conference of the American Society of Nephrology; J Am Soc Neph, Nov 2004 [in-press]

9.         Kalantar-Zadeh K, Brennan ML: Serum myeloperoxidase measurement and its correlates in maintenance hemodialysis patients. 37th annual conference of the American Society of Nephrology; J Am Soc Neph, Nov 2004 [in-press]

10.       Kalantar-Zadeh K, Kamranpour N, Kopple JD: Association between novel  HDL inflammatory/anti-inflammatory properties  with body mass index in hemodialysis patients. 37th annual conference of the American Society of Nephrology; J Am Soc Neph, Nov 2004 [in-press]

11.       Kalantar-Zadeh K, Bross R, Takasu J, Budoff MJ: Associations between markers of malnutrition-inflammation complex syndrome and anemia and coronary artery calcification in hemodialysis patients. 37th annual conference of the American Society of Nephrology; J Am Soc Neph, Nov 2004 [in-press]

12.       Kalantar-Zadeh K, Bross R, Zitterkoph J, Colman S, Gjertson DW, Kopple JD: Comparing four body composition assessment methods for body fat measurement in dialysis patients. 37th annual conference of the American Society of Nephrology; J Am Soc Neph, Nov 2004 [in-press]

 


 

Contact:

Kamyar Kalantar-Zadeh, MD, PhD, MPH, FAAP, FACP
Assistant Professor of Medicine and Pediatrics
Director of Off-Campus Dialysis Expansion Program and Epidemiology
UCLA David Geffen School of Medicine
Harbor-UCLA Medical Center
1124 W. Carson St., C-1 Annex, Box 406
Torrance, CA 90502-2064 
Tel: (310) 222-3891
Fax: (310) 782-1837
Cell: (310) 686-7908
Pager: (310) 501-2692
Email Address:  kamkal@ucla.edu
http://www.nephrology.rei.edu/kkalantar.htm

 


 

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