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no evidence of intolerance. Feeding regimens were continued for 7 days post-randomization or until death, whichever
came first.
The patients included in the data analysis had a mean age
of 55 years, Acute Physiology and Chronic Health Evaluation
(APACHE) II score of 20, NUTRIC score 3.8, and were primarily Caucasians. Most demographic and clinical parameters were similar between the control and intervention group.
There were more medical ICU patients (59%) than surgical
ICU patients (41%). The average total calories and protein
received by the patients were 26% and 22% higher, respectively, in the intervention group over the EN only group
(both P < .001). There was no difference between the 2
groups in mortality (ICU, hospital, and 6-month), duration of
mechanical ventilation, suspected infections, functional outcomes, and quality of life assessment.
This pilot study is valuable in that it paves the way to a
larger clinical trial in further understanding the optimal feeding strategy for ICU patients with BMI <25 or >35 kg/m2.
However, it must be emphasized this is only a feasibility
study, and not powered to meaningfully compare differences
in survival and clinical outcomes. It is also important to point
out some major irregularities and limitations. First, the definition of SPN is different from that in other published literature. The data analyzed from the intervention group included
patients showing no evidence of EN intolerance or not
receiving PN at all. The mean duration of PN was short at 5.9
days, and the nutrition risk appeared low, as reflected by the
NUTRIC scores. In estimating caloric requirements in
patients with BMI >35 kg/m2, the investigators calculated
adjusted body weight by using a BMI of 25 kg/m2 to determine the patient's ideal body weight. This is not a validated
approach, and the targeted caloric provision of 25 kcal/kg/d
is clearly at odds with the current guidelines in obese ICU
patients. Finally, the ILE used in the intervention arm contained 80% olive oil and 20% soybean oil. Olive oil contains
a significantly higher amount of oleic acid than the more proinflammatory linoleic acid as present in soybean oil. If these
confounders and limitations are carried over to the future
clinical trial, the generalizability of the results, especially on
clinical outcomes and survival, may be greatly limited.
6.

Zaloga et al: Safety and efficacy of subcutaneous
parenteral nutrition in older patients: a prospective
randomized multicenter clinical trial.10

The objective of this prospective, randomized, open-label
multicenter noninferiority study was to compare the safety
and efficacy of a 12-hour daily infusion of a standardized,
commercially available peripheral PN formulation (410
kcal and 28 g protein/L) via subcutaneous (SC) infusion to
peripheral intravenous (PIV) infusion. One hundred twentyone older (age: ≥65 years), stable hospitalized patients were
included in this study. Patients were treated for 7 to 10 days
and followed for 21 days or until time of discharge.

Fifty-nine patients received SC and 61 patients received PIV
administration of PN. There was no significant difference in
the primary composite outcome of major local side effects
(27.1% SC vs 44.3% PIV, P = .059) which included large
local edema (>10 cm), blistering (>2 cm), erythema (>10 cm
diameter), unbearable pain, and switch in administration
method. In the PIV group, a significantly greater number of
patients had a switch in PN administration route (0% SC vs
34.4% PIV, P < .001) and reduced duration of treatment (7.4
± 2.4 days SC vs 5.8 ± 2.9 days PIV, P < .001). As a result,
the total treatment intake was significantly higher in the SC
group (126.7 ± 49.7 mL/kg SC vs 101 ± 52.9 mL/kg PIV, P
= .008). Large local edema was found to occur more in the
SC group (13 patients SC vs 5 patients PIV, P = .042); however, it was noted to have resolved prior to the next day's
infusion and did not result in patient discomfort or switch to
PIV administration of nutrients. No significant differences
were found in secondary outcomes related to nutritional
parameters, biochemistry parameters, and clinical outcomes.
The researchers concluded that SC administration of a commercially available peripheral PN formulation was not inferior to PIV administration in terms of local tolerance in older
patients with malnutrition, and that this type of therapy may
be useful as supplemental therapy in select patients not
requiring an intravenous catheter.
This is the first study to evaluate the safety and efficacy
of SC administration of a peripheral PN formulation. The
results are comparable with previously published hyperdermoclysis studies using hydration and amino acid solutions.38-40 This study incorporated a wide range of disease
states in the elderly population. One limitation is that while it
was a multicenter study, all sites were within France. In addition, daily SC nutrient provision was limited to 410 kcal and
28 g of protein due to the need to limit volume (1 L/24 h) and
solution osmolarity (845 mOsm/L) to prevent complications.
Furthermore, patients were allowed unrestricted oral intake
during the study period and oral intake data were not
reported; therefore, the impact of such treatment intervention
is confounding, especially when looking at clinical outcomes. One potential solution to such limited nutrition
administration is to use multiple sites daily which was not
studied and tolerance to such is unknown. There was also
potential for bias in this study as lead investigators are
employed by the study sponsor. In summary, SC administration of a commercially available peripheral PN appears to
hold promise; however, trials providing higher nutrient
intakes are needed to provide additional guidance regarding
the usefulness of such therapy in clinical practice.

Conclusion
With the large volume of publications pertinent to nutrition
support therapy and their appearance in a variety of journals,
it is extremely difficult for the pharmacist engaged in nutrition support practice to stay current with the literature. We

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