Clinical UM Guideline

This document addresses intradialytic parenteral nutrition (IDPN). IDPN involves the infusion of intravenous hyperalimentation formula during dialysis with aim of treating protein calorie malnutrition, which sometimes occurs in individuals with renal failure.

Note: Please see the following related document for additional information:

• CG-MED-89 Home Parenteral Nutrition

Not Medically Necessary:

Intradialytic parenteral nutrition is considered not medically necessary for all indications.

The following codes for treatments and procedures applicable to this guideline are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services are Not Medically Necessary:
For the following procedure and diagnosis codes, or when the code describes a procedure designated in the Clinical Indications section as not medically necessary.

It is estimated there are nearly 808,000 people in the United States with end-stage renal disease (ESRD) with 69% receiving dialysis. Malnutrition is a common complication in individuals with ESRD. Causes of malnutrition may include inadequate dialysis, decreased protein consumption, inadequate caloric intake due to loss of appetite, loss of amino acids in the dialysis solution, and imbalances such as acidosis, hyperparathyroidism, and insulin resistance. In addition to the factors listed above, ESRD often exists simultaneously with other conditions such as diabetes, cardiovascular disease, and peripheral vascular disease, which may also contribute to malnutrition in these individuals.

Long-term total parenteral nutrition (TPN) is frequently necessary when parenteral feedings are indicated for an extended period of time, peripheral access is not available, nutrient needs are substantial, or fluid restrictions are required. In individuals being treated with dialysis who are considered candidates for TPN, intradialytic infusion may be offered as an alternative to a regularly scheduled infusion of TPN.

IDPN is the infusion of hyperalimentation formula administered during either a hemodialysis or peritoneal dialysis session and may consist of a mixture of amino acids, dextrose and lipids via an infusion pump. IDPN can be advantageous to those with ESRD since there is no need for an additional vascular access. Multivitamins, electrolytes, trace elements, and drugs such as insulin can be added when necessary. There is no significant increase in the time needed to complete a dialysis session and monitoring by dialysis center staff reduces the risk of electrolyte and mineral imbalance.

A retrospective case series compared the morbidity of 1679 individuals treated with IDPN compared with 22,517 nontreated individuals (Chertow, 1994). The study found for those receiving dialysis with lower levels of serum albumin (≤ 3.4 g/dL), treatment with IDPN was associated with a reduction in the odds of death at 1 year. However, treatment with IDPN in those with a normal serum albumin was associated with increased mortality. Three other uncontrolled studies also suggest improved outcomes associated with intradialytic parenteral nutrition (Capelli, 1994, Foulks, 1994, Pupim, 2002). Due to the numerous biases inherent in any uncontrolled trials, these studies cannot validate whether IDPN is associated with an improved mortality. The observed treatment effect could be related to a selection bias in which very ill individuals were not offered IDPN. These studies do suggest that being selected for IDPN may be associated with an improved mortality rate, but analysis of the direct contribution of therapy requires controlled trials. These individuals experienced a significant decrease in the odds ratio for death at 1 year compared to those who were not treated with IDPN.

Protein-energy wasting (PEW) is the progressive depletion of protein and energy stores (for example fat and muscle) and is highly prevalent in those who are receiving hemodialysis.

Literature reviews have shown inconclusive outcomes and inconsistent results regarding the use of IDPN for PEW (Anderson, 2019; Dukkipati, 2010). In 2022, Kittiskulnam and colleagues published an open label randomized controlled trial that evaluated the effects of intradialytic parenteral nutrition on nutritional outcomes in individuals with PEW who were unable to tolerate oral nutritional supplements. All participants were randomized in a 1:1 fashion to either receive IDPN plus standard counselling (treatment group, n=18) or intensive dietary counselling (control group, n=20) for 3 months. Participants were then followed for an additional 3 months. After 3 months of IDPN, the mean serum albumin level increased by 0.3 (95% confidence interval [CI]; 0.2–0.4) g/dL from baseline and was higher in the treatment group (3.8 ± 0.2 g/dL) compared to the control group (3.5 ± 0.3 g/dL) (p=0.01). Body weight increased from 59.3 ± 12.1 kg to 61.2 ± 11.9 kg after 3 months of treatment while it remained unchanged in the control group (from 55.4 ± 11.2 to 56.1 ± 11.4 kg, p=0.22). After 6 months of follow-up, the average serum albumin in the treatment group decreased by 0.1 (95% CI; -0.3 to 0.4) g/dL but was still higher when compared with baseline (3.7 ± 0.2 vs 3.5 ± 0.3 g/dL, respectively, p=0.04). The increase in albumin level was not clinically meaningful.

Serum prealbumin can serve as a marker for progress since it can be a predictor of mortality and hospitalization and an indicator for morbidity and mortality in malnourished hemodialysis individuals during nutritional therapy. In 2017, Marsen and colleagues published a prospective, multicenter, randomized, open label, controlled, trial assessing the impact of IDPN on prealbumin in 107 maintenance hemodialysis individuals suffering from PEW. Participants in the treatment group (n=53) received nutritional counselling along with three administrations of IDPN a week over a period of 16 weeks. Participants in the control group received nutritional counselling only (n=54). There were 32/53 participants (60.4%) in the intervention group and 47/54 participants (87.0%) in the control group who completed all trial visits. There were 28 participants who terminated the trial prematurely. Reasons for dropout were death (11 participants), occurrence of adverse events, a longer hospital stay, lack of efficacy, loss to follow-up, need for IDPN treatment in the control group, and withdrawal of consent. For those in the intervention group, mean increase in serum prealbumin from baseline to week 16 was 26.31 mg/L (± 58.66 mg/L) compared with a decrease of 1.84 mg/dL (± 49.35 mg/L) in the control group (p=0.02). Those in the intervention group had a sustained prealbumin response to intradialytic parenteral nutrition therapy which lasted for 6 weeks following therapy (change from baseline: 30.74 ± 58.06 mg/L at week 22; p=0.04), followed by a slow decline at week 12 post intervention (change from baseline: 15.08 ± 59.55 mg/L at week 28), while for those in the control group, the mean prealbumin levels remained unchanged from baseline (1.44 ± 50.52 mg/L at week 22; 0.10 ± 56.63 mg/L at week 28). There were no acute side effects during administration of intradialytic parenteral nutrition.

In 2009, the European Society for Clinical Nutrition and Metabolism (ESPEN) published guidelines for Parenteral Nutrition: Adult Renal Failure (Cano, 2009). They state PEW is an independent determinant of morbidity and mortality for those receiving hemodialysis and retrospective studies suggest IDPN may reduce hospitalization rate and survival, but that large, randomized controlled trials are needed to evaluate the effects of intradialytic parenteral nutrition.

In 2010, the American Society for Parenteral and Enteral Nutrition (ESPEN) published guidelines for Nutrition Support in Adult Acute and Chronic Renal Failure (Brown, 2010). The guidelines recommend IDPN should not be used for malnourished individuals with chronic kidney disease.

Also in 2020, the National Kidney Foundation’s Kidney Disease Outcomes Quality Initiative published guidelines for nutrition in chronic kidney disease (Ikizler, 2020). The guidelines suggest for those with chronic kidney disease and PEW, a trial of IDPN can be done to assist with nutrition if requirements cannot be met with existing oral and enteral intake.

In conclusion, peer-reviewed published literature fails to demonstrate IDPN is in accordance with generally accepted standards of medical practice. Studies do not show clinically significant improvements.

Intradialytic Parenteral Nutrition (IDPN): A method of intravenously delivering nutritional substances (carbohydrate, protein, fat, and required trace elements) to individuals during dialysis.

Intravenous: Within a vein or veins.

Parenteral nutrition: Provision of nutrients intravenously.

Peer Reviewed Publications:

1. Anderson J, Peterson K, Bourne D, Boundy E. Effectiveness of intradialytic parenteral nutrition in treating protein-energy wasting in hemodialysis: a rapid systematic review. J Ren Nutr. 2019; 29(5):361-369.
2. Capelli JP, Kushner H, Camiscioli TC, et al. Effect of intradialytic parenteral nutrition on mortality rates in end stage renal disease care. Am J Kidney Dis. 1994; 23(6):808-816.
3. Carrero JJ, Severs D, Aguilera D, et al. Intradialytic parenteral nutrition for patients on hemodialysis: when, how and to whom? Clin Kidney J. 2022; 16(1):5-18.
4. Chertow GM, Ling J, Lew NL, et al. he association of intradialytic parenteral nutrition administration with survival in hemodialysis patients. Am J Kidney Dis. 1994; 24(6):912-920.
5. Dukkipati R, Kalantar-Zadeh K, Kopple J. Is there a role for intradialytic parenteral nutrition? A review of the evidence. Am J Kidney Dis. 2010; 55(2):352-364.
6. Foulks CJ. The effect of intradialytic parenteral nutrition on hospitalization rate and mortality in malnourished hemodialysis patients. J Renal Nutr. 1994; 4(1):5-10.
7. Kittiskulnam P, Banjongjit A, Metta K, et al. The beneficial effects of intradialytic parenteral nutrition in hemodialysis patients with protein energy wasting: a prospective randomized controlled trial. Sci Rep. 2022; 12(1):4529.
8. Korzets A, Azoulay O, Ori Y, et al. The use of intradialytic parenteral nutrition in acutely ill haemodialysed patients. J Ren Care. 2008; 34(1):14-18.
9. Marsen TA, Beer J, Mann H; et al. Intradialytic parenteral nutrition in maintenance hemodialysis patients suffering from protein-energy wasting. Results of a multicenter, open, prospective, randomized trial. Clin Nutr. 2017; 36(1):107-117.
10. Pupim LB, Flakoll PJ, Brouillette JR, et al. Intradialytic parenteral nutrition improves protein and energy homeostasis in chronic hemodialysis patients. J Clin Invest. 2002; 110(4):483-492.
11. Rambod M, Kovesdy CP, Bross R, et al. Association of serum prealbumin and its changes over time with clinical outcomes and survival in hemodialysis patients. Am J Clin Nutr 2008; 88(6):1485-1494.

Government Agency, Medical Society, and Other Authoritative Publications:

1. Brown RO, Compher C, Society for Parenteral and Enteral Nutrition Board of Directors. A.S.P.E.N. clinical guidelines: nutrition support in adult acute and chronic renal failure. JPEN J Parenter Enteral Nutr. 2010; 34(4):366-377.
2. Cano N, Aparicio M, Brunori G, et al. ESPEN guidelines on parenteral nutrition: adult renal failure. Clin Nutr. 2009; 28(4):401-414.
3. Ikizler TA, Burrowes JD, Byham-Gray LD, et al. KDOQI clinical practice guideline for nutrition in CKD: 2020 update. Am J Kidney Dis. 2020; 76(3 Suppl 1):S1-S107.
4. National Institute of Diabetes and Digestive and Kidney Diseases. Fast facts on kidney disease. May 2023. Available at: https://www.niddk.nih.gov/health-information/health-statistics/kidney-disease. Accessed on October 16, 2024.

1. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). Kidney failure. October 2017. Available at: https://www.niddk.nih.gov/health-information/kidney-disease/kidney-failure. Accessed on October 17, 2024.
2. National Kidney Foundation. Kidney failure (ESRD) symptoms, stages, & treatment. September 5, 2023. Available at: https://www.kidney.org/kidney-topics/kidney-failure Accessed on October 17, 2024.

Dialysis
IDPN
Intradialytic parenteral nutrition