Effect of High-Protein Meals During Hemodialysis Combined With Lanthanum Carbonate in Lypoalbuminemic Dialysis Patients

Findings From the FrEDI Randomized Controlled Trial

Connie M. Rhee; Amy S. You; Tara Koontz Parsons; Amanda R. Tortorici; Rachelle Bross; David E. St-Jules; Jennie Jing; Martin L. Lee; Debbie Benner; Csaba P. Kovesdy; Rajnish Mehrotra; Joel D. Kopple; Kamyar Kalantar-Zadeh

Disclosures

Nephrol Dial Transplant. 2017;32(7):1233-1243. 

In This Article

Abstract and Introduction

Abstract

Background: Inadequate protein intake and hypoalbuminemia, indicators of protein-energy wasting, are among the strongest mortality predictors in hemodialysis patients. Hemodialysis patients are frequently counseled on dietary phosphorus restriction, which may inadvertently lead to decreased protein intake. We hypothesized that, in hypoalbuminemic hemodialysis patients, provision of high-protein meals during hemodialysis combined with a potent phosphorus binder increases serum albumin without raising phosphorus levels.

Methods: We conducted a randomized controlled trial in 110 adults undergoing thrice-weekly hemodialysis with serum albumin <4.0 g/dL recruited between July 2010 and October 2011 from eight Southern California dialysis units. Patients were randomly assigned to receive high-protein (50–55 g) meals during dialysis, providing 400–500 mg phosphorus, combined with lanthanum carbonate versus low-protein (<1 g) meals during dialysis, providing <20 mg phosphorus. Prescribed nonlanthanum phosphorus binders were continued over an 8-week period. The primary composite outcome was a rise in serum albumin of ≥0.2 g/dL while maintaining phosphorus between 3.5–<5.5 mg/dL. Secondary outcomes included achievement of the primary outcome's individual endpoints and changes in mineral and bone disease and inflammatory markers.

Results: Among 106 participants who satisfied the trial entrance criteria, 27% (n = 15) and 12% (n = 6) of patients in the high-protein versus low-protein hemodialysis meal groups, respectively, achieved the primary outcome (intention-to-treat P-value = 0.045). A lower proportion of patients in the high-protein versus low-protein intake groups experienced a meaningful rise in interleukin-6 levels: 9% versus 31%, respectively (P = 0.009). No serious adverse events were observed.

Conclusion: In hypoalbuminemic hemodialysis patients, high-protein meals during dialysis combined with lanthanum carbonate are safe and increase serum albumin while controlling phosphorus.

Introduction

Protein-energy wasting is a common condition and a major risk factor for adverse outcomes including higher death risk in chronic kidney disease (CKD) patients undergoing maintenance hemodialysis.[1] Biochemical markers of protein-energy wasting such as hypoalbuminemia (defined as a serum albumin <4.0 g/dL) are among the most potent predictors of death risk in dialysis patients.[2–4] Given that heightened catabolism, low-protein intake and dialytic amino acid and protein losses may predispose hemodialysis patients to hypoalbuminemia and subsequent protein-energy wasting, the National Kidney Foundation–Kidney Disease Outcomes Quality Initiative (NKF-KDOQI) Clinical Practice Guidelines recommend a higher protein intake of 1.2 g/kg body weight/day in this population.[2] Despite these recommendations, epidemiologic data show that >50% of hemodialysis patients have inadequate dietary protein intake (<1.0 g/kg/day) as estimated by their calculated urea kinetic–based normalized protein catabolic rates (nPCRs), also known as normalized protein nitrogen appearance (nPNA).[5]

Multiple barriers may hinder the achievement of these nutritional targets in hemodialysis patients. For example, many high-protein foods are rich in phosphorus, leading to hyperphosphatemia, which has been associated with renal bone disease, cardiovascular disease including vascular calcification and higher mortality risk.[6–11] As such, hemodialysis patients are frequently counseled on dietary phosphorus restriction, which may inadvertently lead to a reduction in protein intake.[8,12,13] Second, thrice-weekly dialysis sessions may coincide with core meal times, leading to inadequate food intake on dialysis treatment days.[14] This issue may be compounded by the fact that many outpatient dialysis units in the USA refrain from administering meals and prohibit outside food or beverage consumption during dialysis, given concerns about postprandial hypotension, aspiration, infection risk, staff burden and financial constraints.[13,15] Third, the importance of nutritional status, as well as the benefits of nutritional supportive measures, may remain under-recognized and underprioritized in the hemodialysis population.

It has been suggested that dietary liberalization in conjunction with greater use of phosphorus binders may be a more effective strategy in addressing the inadequate protein intake of hemodialysis patients.[12,13,16] To better inform the field, we designed the randomized controlled trial Fosrenol (lanthanum carbonate) for Enhancing Dietary Protein Intake in Hypoalbuminemic Dialysis Patients (FrEDI) in order to test the hypothesis that the provision of high-protein meals during hemodialysis treatment sessions in the dialysis clinic combined with a potent phosphorus binder in hypoalbuminemic hemodialysis patients would increase serum albumin levels without adversely impacting their phosphorus levels.

Comments

3090D553-9492-4563-8681-AD288FA52ACE

processing....