Specialized Formulas

Specialized formulas are designed for specific disease states or conditions; however,

clinical benefits are often controversial. Formulas generally have a good theoretic

basis for use, yet many lack conclusive clinical evidence of improved efficacy

compared with standard formulas. Well-designed studies showing a difference in

outcome between specialized and standard enteral formulas providing equal nitrogen

and equal calories are limited for most types of specialized formulas. As shown in

Table 37-2, there are several different types of specialized formulas; costs and

evidence for use vary greatly among them.

D.S. requires EN because he cannot adequately protect his airway when

swallowing. There is no evidence presented to suggest he has problems with

digestion or absorption. One of the polymeric formulas on the hospital EN formulary

should be selected for D.S. The choice of polymeric formula can be narrowed by

several factors, including requirements for calories, protein, fluid and fiber, as well

as potential nutrient intolerances.

CASE 37-2, QUESTION 3: What are D.S.’s requirements for calories, protein, and fluid? Does he have any

special nutrient requirements?

D.S.’s nutrient requirements must be assessed before proceeding in the selection of

enteral formula. Based on his weight–height ratio, 10% weight loss over 6 months,

slightly elevated CRP, and mild muscle wasting D.S. has moderate malnutrition in the

context of chronic illness. Low serum albumin is a risk factor for morbidity and

mortality, but is not a reliable indicator of nutritional status.

2 Weight loss to 85% of

ideal body weight ([IBW], 73 kg) most likely is due to chronic deficiency in total

energy intake, but may also be associated with significant loss of lean mass,

especially in older men.

23

Because D.S. has an IBW less than the ideal for his height, his actual weight

should be used to estimate energy and protein requirements. Use of IBW to estimate

requirements for undernourished patients may result in fluid and electrolyte

imbalance. Once the patient is stabilized on nutrition support, calories can be

increased, if necessary, to achieve weight gain.

D.S.’s level of metabolic stress is relatively low. He has no surgical wounds,

fractures or skeletal trauma, burns, or major infections, although CRP indicates mild

inflammation. Caloric requirements are only slightly higher than basal needs.

Although the term calorie is used interchangeably with kilocalorie (kcal) in nutrition

literature, the large “Calorie” or kilocalorie technically is correct and energy

requirements generally are listed as kcal/day or kcal/kg body weight when specific

numbers are given for a patient. See Chapter 35, Basics of Nutrition and Patient

Assessment, for methods of determining nutrient requirements. An estimation of 20 to

25 kcal/kg actual weight can be used based on D.S.’s low level of metabolic stress,

but higher caloric intake (25–30 kcal/kg/day) may be needed for weight gain after he

is stable.

Protein requirements for healthy elderly people are controversial but estimated to

be 1 to 1.2 g/kg/day, which is higher than the DRI of 0.8 g/kg/day.

24 D.S.’s protein

needs are estimated to 1 to 1.2 g/kg actual weight per day, minimum, based on

inflammation and chronic malnutrition. Renal function appears adequate for D.S. to

tolerate 1.2 g/kg/day without experiencing azotemia. SCr, however, may provide a

poor estimate of renal function in underweight patients owing to less-than-normal

muscle mass.

Daily fluid requirements for geriatric patients can be estimated at 30 mL/kg or 1

mL/kcal ingested, with a minimum of 1,500 mL daily, plus replacement of excess

losses from hyperthermia, vomiting, or diarrhea.

24 Baseline requirements of 1,500

mL for the first 20 kg plus 20 mL per each additional kilogram of body weight also

can be used to estimate fluid requirements. D.S. does not appear to have any excess

fluid losses at this time; therefore, calculation of baseline fluid requirements should

provide adequate fluids.

D.S.’s estimated daily requirements are approximately 1,240 to 1,550 total

calories, 62 to 74 g protein, and about 1,860 mL of fluid. These are estimated

requirements that should be adjusted based on frequent reassessment of D.S.’s

response to therapy and changes in his clinical situation. Additional calories and

protein may be needed for repletion of weight and protein status.

D.S.’s apparently suboptimal nutrition before hospitalization increases his risk for

vitamin deficiencies (see Chapter 35, Basics of Nutrition and Patient Assessment).

Medical, medication, and dietary histories should be evaluated to determine

nutritional risks associated with specific conditions. D.S.’s age, along with his acute

illness and chronic malnutrition, increases his risk of vitamin deficiencies, and he

may have at least some subclinical deficiencies. He should receive 100% of the DRI,

minimum, for vitamins and minerals daily.

17

If actual deficiencies are identified, D.S.

will require higher, therapeutic doses for the specific vitamins that are deficient.

D.S. may be at risk of refeeding syndrome. His weight is low (85% of IBW),

although his body mass index is acceptable at 19.5 kg/m2

. Chronic malnutrition can

lead to intracellular depletion of potassium, phosphorus, and magnesium, whereas

serum concentrations are maintained. When specialized nutrition support begins,

refeeding syndrome may develop as these electrolytes move from the extracellular

space into the cells, causing a decrease in serum concentrations during the first few

days of feeding.

25 Failure to monitor the patient and replace electrolytes as necessary

can result in serious electrolyte abnormalities. Knowing D.S.’s weight history,

particularly recent weight loss, and his diet history could help assess his potential for

clinically significant electrolyte and fluid abnormalities associated with refeeding

syndrome.

CASE 37-2, QUESTION 4: Which category of polymeric formulas would be most appropriate for D.S.

based on his estimated nutritional requirements?

Polymeric formulas can be divided into several categories based on nutrient

sources, caloric density, and protein content. Each category should be evaluated

because formula characteristics overlap between the categories.

NUTRIENT SOURCE

Polymeric formulas can be subdivided based on lactose content. Hospitalized

patients are presumed to be lactose intolerant due to reduced disaccharidase

production during fasting, malnutrition, and various GI tract diseases.

26,27

In addition,

most ethnic groups, except northern Europeans, have reduced lactase production in

adulthood, leading to lactose intolerance. Lactose ingestion can cause bloating,

flatulence, abdominal cramps, and watery diarrhea in patients with permanent or

transient lactose intolerance. Lactose-free formulas are the standard for tube-fed

adults. Most enteral products are lactose-free, except the powdered products

reconstituted with milk and generally intended for oral consumption. Proteins, even

those derived from milk, do not contribute to lactose content because lactose is a

carbohydrate. The majority of enteral formulas are also gluten-free to avoid GI

symptoms associated with celiac disease.

p. 773

p. 774

Table 37-3

General Descriptions of Macronutrient Quantity in Enteral Formulas

Low Standard Moderate High Very High

Caloric density (kcal/mL) <1 1–1.2 1.5 1.8–2 >2

Free water (%) 65%–75% 80%–85% 75%–80% >85%

Nitrogen (protein) content: %

kcal as protein

6%–10% 11%–16% 17%–20% >20%

Nitrogen (protein) content:

NPC:N

>200:1 200:1–130:1 125:1–100:1 <100:1

Fiber content (g/1,000 kcal) 1–9 None >9–<14 ≥14

NPC:N, nonprotein calorie to nitrogen ratio.

CALORIC DENSITY

Caloric density influences the volume of formula needed to meet nutrient

requirements. Standard caloric density is 1 to 1.2 kcal/mL. Table 37-3 lists the

general descriptions for caloric density and macronutrient quantities in enteral

formulas. Increased caloric density increases formula osmolality. Gastric emptying

can be reduced when osmolality exceeds 800 mOsm/kg and this may result in feeding

intolerance.

28 GI intolerance (e.g., nausea, flatulence, abdominal discomfort) also can

occur if the capacity of intestinal enzymes is overwhelmed by infusion of a

calorically dense formula.

Caloric density reflects the free-water content of EN formulas. Risk of dehydration

increases with increasing caloric density; however, standard caloric density formulas

can result in fluid overload in patients with congestive heart failure, renal failure, or

other fluid-sensitive conditions. Calculation of water provided by EN helps

determine the volume of additional fluid needed to meet daily fluid requirements.

Free-water content is generally 80% to 85% (800–850 mL/L of formula) for

formulas with 1 to 1.2 kcal/mL. Table 37-3 lists free-water content associated with

other caloric densities. The available history for D.S. does not suggest a need for

fluid restriction; therefore, it would be reasonable to initiate feedings with a standard

caloric density product (1–1.2 kcal/mL).

PROTEIN CONTENT

Protein needs increase disproportionately to caloric needs during injury and critical

illness, whereas protein tolerance may limit protein provision in other conditions. To

meet the need for varying ratios between calories and protein, polymeric formulas

are available with a range from low- to very high protein content. Either percentage

of calories from protein or nonprotein calories to nitrogen (NPC:N) ratio can be used

to define protein content. Table 37-3 lists general descriptions for protein content.

High-nitrogen enteral formulas are designed for patients with an increased protein

requirement without a proportional increase in caloric needs. Very high nitrogen

formulas are generally intended for critically ill patients or those with large wounds

to heal. Low-nitrogen formulas are available for patients requiring protein

restriction. Some low-nitrogen formulas are designed for patients with reduced renal

function and can be classified as specialized formulas.

D.S. could obtain adequate protein from a formula with standard protein content. A

formula with slightly higher-protein content (17%–18% of calories) would also be

acceptable. A high-nitrogen formula that meets D.S.’s calorie needs will provide

protein at the upper end of the estimated requirement (1.2 g/kg/day), whereas a

standard-nitrogen formula will provide between 0.8 and 1 g/kg/day. A high-nitrogen

formula may replete D.S.’s somatic and visceral protein status sooner but it may not

provide adequate calories for weight gain. The decision to use a high-nitrogen versus

standard-nitrogen formula depends on the exact nutrient composition of products on

the EN formulary.

CASE 37-2, QUESTION 5: Should the EN product selected for D.S. contain fiber and if so, what type and

amount?

Fiber has potential physiologic benefits, including increased fecal bulk, decreased

bowel transit time in patients susceptible to constipation, increased transit time in

patients with diarrhea, reduction of serum cholesterol, and improved glycemic

control in patients with diabetes. Recommended daily fiber intake for healthy

Americans is 21 to 25 g for women and 30 to 38 g for men, with the lower end of

these amounts for people 51 years of age or older.

29 Adequate intake is determined

by calorie intake and fiber intake observed to protect against coronary artery disease

(14 g/1,000 calories). Optimal fiber intake for ill persons has not been determined.

Fiber-supplemented formulas vary considerably in fiber content. There is no

standardized terminology for low-fiber, moderate-fiber, and high-fiber content;

however, the amounts listed in Table 37-3 can serve as a general guideline.

Enteral formulas may contain either insoluble or soluble fiber, or both. Insoluble

fiber is associated with changes in fecal bulk and transit time, whereas soluble fiber

tends to be responsible for effects on cholesterol and glycemic control. Soluble

fibers, such as pectin, psyllium, and certain gums, tend to form gels and are used as a

single fiber source only for low-fiber formulas. Fructooligosaccharides (FOS) are

naturally occurring sugars that are added to some enteral formulas for soluble fiber

benefits with better formulation characteristics (i.e., less gelling). Soluble fibers and

FOS can be fermented to short-chain fatty acids by Bifidobacterium in the colon.

30,31

Short-chain fatty acids stimulate colonic blood flow, enhance fluid and electrolyte

absorption, and provide a trophic effect in the colon.

The most common fiber source for enteral formulas is soy polysaccharide, or soy

fiber. Although soy polysaccharide demonstrates beneficial effects associated with

both soluble and insoluble fibers in healthy subjects and non-critically ill patients,

studies do not provide clear evidence of improved bowel function in critically ill

patients.

31 Routine use of fiber is not supported by available data in critically ill

patients.

18–20 Given available data, stable patients on long-term EN appear most

likely to benefit from fiber-supplemented formulas. Some patients on short-term EN

without GI pathology who experience altered stool consistency may benefit from

fiber supplementation.

p. 774

p. 775

Addition of fiber to enteral formulas creates some potential problems. Fiber

increases viscosity and fiber-containing formulas often require a pump for

administration through feeding tubes. GI symptoms from fiber can include increased

gas production and abdominal discomfort.

27,31

Improvement in constipation has been

noted with FOS administration; however, intake of greater than 45 g/day may cause

diarrhea.

32 Flatulence and bloating can limit tolerance to FOS for some patients.

Gradual introduction of fiber may help reduce these symptoms. Bezoar formation

also has been reported in a patient receiving fiber-containing tube feedings and

medications that suppressed GI motility.

31 Caution is advised for the use of fibercontaining formulas in patients with poor GI motility and underlying GI dysfunction.

Insoluble fiber should be avoided in critically ill patients, and patients at high risk of

bowel ischemia or severe dysmotility should not receive either soluble or insoluble

fiber.

4

Inadequate fluid intake may also contribute to the risk of bezoar formation and

intestinal blockage with fiber.

D.S. is not critically ill and does not appear to have bowel pathology precluding

use of a fiber-containing formula. He will require EN for a moderate duration of time

and potentially long term. It would be reasonable to provide a formula with at least

moderate fiber content. However, D.S. could experience GI symptoms from the fiber,

especially if his diet has previously been of low-fiber content. If necessary, a lowfiber formula could be used initially and then transitioned to higher fiber once

symptoms of bloating and gas improve.

CASE 37-2, QUESTION 6: What is an appropriate administration regimen for D.S.’s tube feeding?

The feeding route, formula selected, and anticipated duration of feeding influence

the administration regimen. Patient location (e.g., hospital, nursing facility, home)

and cost also are considered when developing the regimen, including the rate for

initiating and advancing feedings, and the administration method (i.e., syringe, gravity

drip, pump).

Limited scientific data exist regarding EN administration regimens; thus, expert

opinion plays an important role and different regimens can be used in various

settings, all of which appear to meet the needs of the patients and personnel. The

administration regimen should be adjusted as necessary for feeding intolerance. Four

basic schedules for formula delivery are available: (a) continuous infusion, (b)

cyclic infusion, (c) intermittent infusion, and (d) bolus delivery of formula.

Continuous Infusion

Continuous infusion provides formula at a continuous rate for 24 hours/day and can

be used with any route of feeding. Intragastric continuous infusion is most commonly

used for hospitalized patients, although small bowel feeding may be more

appropriate in certain settings (e.g., ICU).

18–20 Risks of gastric distension and

aspiration may decrease with continuous infusion compared with intermittent gastric

infusion.

14

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