The effect of intradialytic parenteral nutrition on nutritional status and quality of life in hemodialysis patients

Hemodialysis is a life-saving treatment but has a major impact on health
including on nutritional status. Nutritional status and body composition are
closely linked to morbidity, mortality and quality of life (1-3). Muscle mass
appears to be the best read-out for the association between nutritional status
and outcomes(4-12). Protein-energy wasting (PEW) is the term to describe the
state of decreased body stores of protein and energy fuels (body protein and
fat masses) in chronic kidney disease(13, 14), this is a hypercatabolic state
leading to muscle wasting (sarcopenia) and cachexia (1). PEW comes in from 20
to 70% in chronic hemodialysis patients, with a mean of 40%(13, 14).
Thus, a sarcopenia-correcting intervention in hemodialysis patients has the
potential to improve quality of life. Intradialytic parenteral nutrition (IDPN)
is a nutritional support therapy that is directly administered into the
bloodstream during the hemodialysis session. A study using labeled isotopes
showed that IDPN may represent a sarcopenia-correcting intervention, because it
reversed patients from a state of catabolism to a state of protein synthesis,
especially in muscle(15). However, there is equipoise as to whether IDPN
improves nutritional status and quality of life in hemodialysis patients. This
is related to the fact that most studies are limited in experimental
design(16). Two prospective studies showed that IDPN increased pre-albumin (a
biochemical marker of nutritional status), but showed no survival benefit,
although the studies were likely underpowered to address this endpoint(17, 18).
In a recently completed study we observed that all hemodialysis patients lose
muscle mass during follow-up (3.8 kg in 12 weeks, Figure 1). In a small pilot
study, we observed that IDPN can reduce this muscle wasting by a factor >2.5.
Based on our preliminary data, we propose a 3-month double-blind and
placebo-controlled clinical trial of IDPN in hemodialysis patients with muscle
mass as primary endpoint and quality of life as secondary endpoint.

The aim is to see whether intradialytic parenteral nutrition is an efective
treatment against the loss of muscle mass

The study has the following characteristics:
• Multi-center
• Double-blind
• Randomized
• Placebo controlled

The duration of the study: 4 months; 3 months intervention and 1 month
follow-up.
The setting of the study is: hemodialysis unit of a university hospital.

Intradialytic parenteral nutrition

The measurements will be performed during a dialysis session when patients are
already in the hospital. Additional efforts required from participants include
wearing the activity monitor, keeping an activity diary,and filling out the
questionnaires during dialysis. The risks of study participation are the
increased ultrafiltration volume and other potential side-effects of IDPN.
These risks are limited by close monitoring of overhydration (using the BCM),
blood pressure, body weight, blood volume measurements, and laboratory tests
(e.g., blood glucose and liver enzymes). The potential benefit of the study are
the sarcopenia-correcting effects of the intradialytic parenteral nutrition.