The report is a product of the VA/HSR Evidence Synthesis Program.

Evidence Brief: Treatment for Malnutrition in Hemodialysis Patients

Chronic kidney disease (CKD) is a major public health concern, affecting 15% of US adults in 2011-2014, and was the 9th leading cause of death in the U.S. in 2016. Progression of CKD leads to end-stage renal disease – permanent failure of kidney function requiring kidney transplant or maintenance hemodialysis. Malnutrition affects 20-60% of hemodialysis patients and is one of the strongest predictors of mortality and morbidity in this population. Guidelines recommend nutritional counseling and oral nutrition supplements as first-line treatment; if these strategies do not work, enteral tube feeding is recommended. Another treatment strategy is intradialytic parenteral nutrition (IDPN) – a form of partial parenteral nutrition administered during regularly scheduled dialysis sessions. Despite existing guidelines recommending IDPN only for hemodialysis patients with refractory malnutrition, IDPN is commonly being requested or used prior to other treatment options. However, current evidence is inadequate to demonstrate a benefit for IDPN over recommended treatments.

The VA Renal Field Advisory Committee requested an evidence brief on the use of IDPN for the treatment of malnutrition among VA patients receiving hemodialysis. Investigators with VA's Evidence-based Synthesis Coordinating Center in Portland, OR reviewed the literature including MEDLINE®, CINAHL, the Cochrane Central Register of Controlled Trials, and the Cochrane Database of Systematic Reviews, as well as scientific information requests to four manufacturers, from 2009 to October 11, 2017. After reviewing 258 articles, 14 (5 randomized controlled trials, 6 cohort studies, and 3 systematic reviews) were used to answer the following questions:

What is the effectiveness of IDPN for the treatment of malnutrition in hemodialysis patients?
IDPN does not appear to improve patient health or nutritional outcomes compared to oral supplementation. For example, one year of individualized IDPN treatment did not improve two-year mortality, hospitalization rates, or quality of life in one randomized controlled trial (RCT) of 186 malnourished hemodialysis patients. Further, a single RCT of 107 chronic hemodialysis patients showed that compared to dietary counseling, IDPN did not consistently improve patient health or nutritional outcomes. Generally, IDPN reduced risk of mortality and improved mean scores on various nutritional outcomes compared to usual care; however, usual care was not well-defined in these studies.

What are the potential adverse effects of using IDPN?
Limited data are available regarding the adverse effects of IDPN, with only four of the included studies reporting adverse events. Moreover, interpretation of these findings as consistent evidence of adverse effects is limited by heterogeneity in outcomes, treatment duration, and follow-up duration. In addition, adverse events in these studies may have been artificially under-estimated due to more frequent laboratory monitoring and/or assessment.

What is the cost-effectiveness of using IDPN?
A single study reported a significant decrease in the average number of hospitalizations, cost of hospitalizations, and the length of stay after six months of IDPN therapy. However, when the cost of IDPN was taken into account, there were no overall cost savings for the six months of therapy. Also, this evidence is limited by a lack of comparison to a concurrent non-IDPN control group and limited information on patient, dialysis, and IDPN characteristics.

Do the effectiveness and potential adverse effects of IDPN differ per patient characteristics (i.e., patient demographics, comorbidities, disease severity)?
There is insufficient evidence to draw conclusions about the differential effectiveness of IDPN in subgroups. Although the effects of IDPN may be greater in patients with lower baseline serum albumin levels, confidence in these findings is low as they must be considered taking into account limitations of serum protein levels in screening and outcome assessment of malnutrition.

Conclusions
IDPN has not been demonstrated to improve patient health or clinically important nutritional outcomes over the current guideline recommending treatments of dietary counseling and oral supplementation. Therefore, because of its higher cost, broad usage of IDPN prior to other treatment options does not appear warranted. However, because of its potential improvements in nutritional indicators, investigators agree with existing guidelines that IDPN is a reasonable treatment option when confronted with patients who fail to respond to initial treatments – or are unable to receive these treatments due to malfunctioning gastrointestinal tract or other issues.

Future Research
In order to determine when IDPN should be used, comparisons to each guideline-recommended treatment are needed. The current best evidence comparing IDPN to dietary counseling is limited by sample size, short follow-up duration, indirect outcomes, and lack of information on what kind of intervention (if any) the control group received and potential co-interventions. Additional studies comparing IDPN to oral supplementation also are justified due to limitations in sample size and, potentially, follow-up duration. However, large samples with high levels of adherence and long follow-up time may not be practical in this population due to disease severity and progression. Finally, no study has compared IDPN to enteral tube feeding. In order to justify initiation of IDPN prior to trying enteral tube feeding (for patients with functioning GI tracts), IDPN should be shown to improve patient health and/or nutritional status better than enteral tube feeding in adequately powered, methodologically sound randomized controlled trials.

Reference
Anderson J, Peterson K, Bourne D, Boundy E. Evidence Brief: Use of Intradialytic Parenteral Nutrition (IDPN) to Treat Malnutrition in Hemodialysis Patients. VA ESP Project #09-199; 2018.

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