TPN guideline for user

1. d.
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Parenteral
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Assessment Tools and Guidelines:
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Nutrition
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Therapy
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Assessment Tools and Guidelines:
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Parenteral
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Nutrition
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Therapy
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Jay M. Mirtallo, MS, RPH, FASHP, BCNSP
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DISCLAIMER—This pocket guide is designed to be a summary of
Specialty Practice Pharmacist
ot rm
information. Although it is detailed, it is not an exhaustive pharmaceutical
Nutrition Support/Surgery
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review; the entries in this publication present selected facts about each prod- Department of Pharmacy
pe
rw sio
uct. McMahon Publishing and Hospira assume no liability for the use of this The Ohio State University Medical Center
guide, and the accuracy of the information contained herein is not guaranteed. Columbus, Ohio
is
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Readers are strongly urged to consult any relevant primary literature, the com-
no s p
plete prescribing information available in the package insert of each drug, and
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t e ro h
appropriate clinical protocols. Copyright © 2008, McMahon Publishing,
i
d.
545 West 45th Street, New York, NY 10036. Printed in the USA. All rights
reserved, including the right of reproduction, in whole or in part, in any form.
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3. Figures and Tables Table of Contents
A
Table 1.
ll
Evaluation of Body Weight . . . . . . . . . . . . . . . . . . .7 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6
ri
gh
Co
Figure 1. Algorithm for the administration Nutrition Assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11
ts
py
of nutrition support. . . . . . . . . . . . . . . . . . . . . . .8-9
Nutritional Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
re
ri
Figure 2. Health care organization
gh
se
nutrition consultation request form. . . . . . . . . . . .10 PN Formulation Design . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .19
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©
ed
Table 2. Pharmaceutical and Metabolic Medication Compatibility With PN . . . . . . . . . . . . . . . . . . . . . .24
20
.R
Equations in PN Therapy . . . . . . . . . . . . . . . . . . . .12
09
Glucose Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .33
Table 3. Metabolic Derangements in
ep
M
ro
Which PN Should Be Used With Caution . . . . . . . .14 Guideline for Special Diseases . . . . . . . . . . . . . . . . . . . . . . . . .33
cM on
Table 4. Macronutrients: du Withholding and Withdrawing PN . . . . . . . . . . . . . . . . . . . . . .39
ah in
ct
PN Dosing Guidelines . . . . . . . . . . . . . . . . . . .16-17
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Conclusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .40
Figure 3. Consequences of protein
Pu ol
calorie overfeeding. . . . . . . . . . . . . . . . . . . . . . . .18 References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .41-44
bl e o
is
h
Table 5. Micronutrients: PN Dosing Other Resources . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .45
hi
Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . .20-21
ng n p
Table 6. FDA Requirements for Labeling
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Aluminum Content of PN Products . . . . . . . . . . . .22
up wit
Table 7. ASPEN Safe Practice
un ho
Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . .26-29
le ut
Figure 4. PN formulation standard
ss
order format—renal failure. . . . . . . . . . . . . . . . . .30
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Figure 5. PN formulation standard
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label format—renal failure. . . . . . . . . . . . . . . . . .31
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Table 8. ASPEN Recommendations on
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PN Standardization . . . . . . . . . . . . . . . . . . . . . . . .32
no s p
Table 9. Y-Site Injection Compatibility
n
t e ro h
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of I.V. Medications With PN . . . . . . . . . . . . . . .34-38
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4. Introduction Table 1. Evaluation of Body Weight
A
alnutrition is associated with more frequent treat-
M ll
ment complications and longer stays in the intensive
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% of Ideal Body Weight
current weight
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care unit (ICU) and hospital, as well as increased costs of % of IBW = x 100
IBW
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py
medical care. Patients at high risk for malnutrition should
re
ri
be identified and evaluated for specialized nutrition sup- 80% to 90% = mild malnutrition
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port (SNS).1 70% to 79% = moderate malnutrition
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0% to 69% = severe malnutrition
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Determining the appropriate route of nutrition support
ed
20
for patients at risk for malnutrition is an important consid-
.R % of Usual Body Weight
09
eration when one is attempting to positively influence
ep current weight
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patient outcomes. In patients with a functioning gastroin-
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% of UBW = x 100
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usual weight
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testinal (GI) tract, enteral nutrition (EN) can improve out-
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comes.1 EN has been shown to improve nutritional status 85% to 95% = mild malnutrition
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and reduce length of stay in the ICU and is associated with 75% to 84% = moderate malnutrition
fewer infectious complications than parenteral nutrition
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0% to 74% = severe malnutrition
(PN).2 The major limitation of EN is the need to gain enter-
bl e o
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h
al (postpyloric) access so that the nutrient infusion is tol- IBW, ideal body weight; UBW, usual body weight
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erated and serious complications, such as aspiration Adapted from references 4 and 8.
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pneumonia,are avoided.1 Techniques are available to facil-
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itate access to the GI tract so that enteral tube feedings
up wit
may be administered safely. For patients who have a non-
functioning GI tract, PN is the available method of nutri-
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tional support.3 PN is essential for patients who are
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ss
severely malnourished and have GI tract problems that are
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not expected to resolve within 7 days.1,4 When PN is con-
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sidered, it should be noted that this method is complex
pe
rw sio
and has been associated with a unique set of complica-
is
tions, some of which can be serious or even life-threaten-
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no s p
ing.3 In addition, few published reports can be found that
n
t e ro h
demonstrate a consistently favorable effect of PN on
i
d.
patient outcomes.4
This pocket guide discusses nutritional assessment,nutri-
tional requirements, PN formulation design, medication
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continued on page 11
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6 7

5. Nutrition assessment
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Decision to initiate SNS
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• Aggressive attempt to obtain
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enteral access
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• Feedings may be more appropriate
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distal to the pylorus for patients with
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Functional GI tract? Yes EN
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high gastric residuals, critical
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ed illness, gastroparesis, or pancreatitis
20
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09
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Inconclusive
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EN trial Yes EN tolerated? Yes Continue EN
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Aspiration, abdominal
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No No
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distention, diarrhea,
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Obstruction, peritonitis, high gastric residuals
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paralytic ileus,
mesenteric ischemia,
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PN only if EN
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short-bowel syndrome, PN
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contraindicated
enterocutaneous
up wit
fistula, malabsorption
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Status of Status of
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GI function GI function
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Nonfunctional
pe Functional
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Continue PN Transition to EN
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t e ro h
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Figure 1. Algorithm for the administration
of nutrition support.
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EN, enteral nutrition; GI, gastrointestinal; PN, parenteral nutrition;
i
SNS, specialized nutrition support
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8 9

6. compatibility with PN, and guidelines for special diseases,
A
as well as an overview of evidence-based guidelines pub-
ll lished by the American Society for Parenteral and Enteral
ri
gh
Co
Nutrition (ASPEN).1,3 Also included in the review is a dis-
ts
py
cussion of FDA regulations concerning aluminum
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contamination of PN,5 United States Pharmacopeia (USP)
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se standards for sterile compounding,6 and recommenda-
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tions on the use of insulin in PN.7
ed
20
.R Nutrition Assessment
09
ep
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The purpose of nutrition assessment is to identify the
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degree to which the current or future nutritional status of
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the patient will influence his or her outcome. The current
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nutritional status of the patient is determined by several
factors, including the patient’s weight and how it compares
Pu ol
bl e o
with ideal and usual weights (Table 1,page 7); the duration
is
h
of weight loss if it has occurred; visceral protein status; lab-
hi
oratory values indicative of fluid, electrolyte, and potential
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nutritional deficits; clinical condition; and whether the
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patient may be nourished by oral, enteral, or parenteral
up wit
means.1,4,8 During PN, both pharmaceutical and metabolic
calculations are used in the assessment of nutrition sup-
un ho
port. Equations used to assess clinical, nutritional, and
le ut
ss
metabolic status are provided in Table 2 (page 12).4,9-11
Figure 2. Health care organization
ot rm
nutrition consultation request form. Figure 1 (pages 8-9) is a useful algorithm for determining
he
the appropriate indications for PN. Clinicians should con-
pe
rw sio
sider PN if a trial of enteral feedings has failed, if the enter-
is
al route is contraindicated, or if the GI tract has severely
is
e
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diminished function because of underlying disease or
n
t e ro h
treatment and GI function is not expected to return within
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7 days.1,4 Contraindications to PN include the following: a
functional GI tract; an inability to achieve appropriate
venous access; an unstable clinical condition; and terminal
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i
continued on page 13
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d.
10 11

7. Table 2. Pharmaceutical and Metabolic Equations disease, critical illness, or metabolic derangement for
In PN Therapy
A
which a favorable response to therapy is not feasible or the
ll
1. Predicting Energy Needs risk of complications is too high.4 In these conditions, the
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Using Harris-Benedict Equationa: metabolic profile is such that exogenous nutrients are
ts
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For males: poorly used and frequently cause complications that
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66 + 13.75 (wt in kg) + 5 (ht in cm) – 6.8 (age in years)
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require prolonged mechanical ventilation, intensive care,
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For females:
or hospitalization.4 Table 3 (page 14) lists some metabolic
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655 + 9.6 (wt in kg) + 1.8 (ht in cm) – 4.7 (age in years)
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derangements that necessitate cautious use of PN until the
ed
2. Predicting the Degree of Metabolic Stress
20
patient’s condition improves.4
Catabolic index = .R
09
Applying the algorithm using the aforementioned con-
ep
24-hour urine urea nitrogen [UUN] (g) – (0.5 dietary nitrogen intake + 3)
M
cepts in a nutrition consultation form (Figure 2,page 10) can
ro
Values 0-5 represent moderate stress and >5 represent severe stress.
cM on
du
help improve appropriate use of PN in an institution. Such a
3. Predicting the Degree of Malnutrition
ah in
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form also provides documentation for the need for SNS,and,
i
I. Creatinine height index =
on w
along with the nutrition assessment, includes a recommen-
24 hr actual creatinine excreted in urine (mg)
x 100 dation for route and dose of nutrients to be provided.
Pu ol
24 hr expected creatinine excreted in urine of
bl e o
normal adult of same height
Nutritional Requirements
is
II. Body mass index (kg/m2) = weight (kg) / height (m2)
h
hi
Over the past several years, there has been a continual
ng n p
4. Measuring the Success of Nutrition Support
refinement of PN, focusing on the delivery of the safest,
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Nitrogen balance = (protein intake [g]/6.25) – (24-hour urine urea
i
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nitrogen [g] + 3-5 g) most effective doses. Guidelines provide a framework for
up wit
a Stress factors should not be applied. nutrient doses in a variety of disease states.1,3 In general,
PN, parenteral nutrition there has been a decline in recommended caloric doses,
un ho
Based on references 4 and 9-11.
a liberalization of protein doses, especially for renal and
le ut
ss
liver failure, and more specific recommendations for fat
ot rm
doses (Table 4,pages 16-17).1,3,4,12 Two specific purposes for
he
fat—nonprotein calories and prevention of essential fatty
pe
rw sio
acid deficiency—are listed. Obesity is becoming more
is
prevalent and needs to be considered in dosing of PN.The
is
e
no s p
body mass index is used to classify patients with a value
n
t e ro h
greater than 30 as obese and a value greater than 40 as
i
d.
severely obese.1
Overfeeding of calories and protein can have serious con-
sequences in patients receiving PN and has led to the
ib
i
continued on page 15
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d.
12 13

8. Table 3. Metabolic Derangements in Which specific recommendations provided in Table 4.1,3,4,12 When
A
PN Should Be Used With Caution maximum doses of macronutrients are exceeded, the con-
ll sequences outlined in Figure 3 (page 18) are frequently
ri
Metabolic Derangement Abnormality To Be Corrected
gh
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reported.1,4,13,14
ts
py
Azotemia Blood urea nitrogen Micronutrients—electrolytes, trace elements, and vita-
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ri
>100 mg/dL mins—are essential to the incorporation of macro-
gh
Hyperchloremic se Serum Cl nutrients into the body cell mass. The content of
rv
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metabolic acidosis >115 mEq/L
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micronutrients in the body tends to fluctuate on the basis
ed
20
Hyperglycemia Serum glucose of cellular needs and deficits created by periods of low or
.R
>300 mg/dL
09
no intake or losses, and often occurs in patients with non-
Hypernatremia ep
Serum sodium
M
functional GI tracts. Daily monitoring of serum electrolytes
ro
>150 mEq/L
cM on
du
and periodic (initial and every 2-3 weeks) assessment of
Hyperosmolality Serum osmolality
ah in
ct
>350 mOsm/kg
vitamin and trace element status is essential for a patient
i
on w
requiring PN. Bariatric (gastric bypass) surgery for morbid
Hypochloremic Serum Cl
obesity may result in protein calorie malnutrition as well
Pu ol
metabolic alkalosis <85 mEq/L
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Hypokalemia Serum potassium as deficiencies of thiamine, vitamin B12, folic acid, vitamin
is
h
<3 mEq/L E, and calcium due to malabsorption and/or inadequate
hi
intake caused by complications of the surgery.15 In these
ng n p
Hypophosphatemia Serum phosphorus
<2 mg/dL patients, assessment for vitamin deficiencies should be
r
G art
i
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Based on reference 4. more frequent. Guidelines for dosing of micronutrients in
up wit
PN are outlined in Table 5 (pages 20-21).3,4,16,17
The presence of aluminum as a contaminant in PN has
un ho
caused complications in patients at risk.18 Patients at risk are
le ut
ss
those who receive large loads of aluminum on a per-kilo-
ot rm
gram-of-body-weight basis and/or who have compromised
he
renal function.4 Aluminum toxicity has been observed in
pe
rw sio
neonates receiving PN and adults with renal compromise
is
receiving PN for long periods (home PN therapy). Toxicity
is
e
no s p
primarily affects the bones and central nervous system
n
t e ro h
(CNS).18 Aluminum interferes with bone formation and min-
i
d.
eralization, causing bone fractures or symptoms of bone
pain.19 CNS toxicity has also been observed.18 A dementia
similar to the dialysis dementia observed in patients with
ib
i
continued on page 19
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14 15

9. Table 4. Macronutrients: PN Dosing Guidelines
Normal Range Usual Doses Maximum Special Considerations
A
ll
Calories 20-35 kcal/kg/d Obesity: Hypocaloric doses have been used. Measurement of energy
ri
expenditure is advised.
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Co
Critically ill: 25-30 kcal/kg/d.
ts
py
Glucose 70%-85% of 7 g/kg/d; Improved outcomes have been observed in critically ill patients when
re
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nonprotein 4-5 mg/kg/min blood glucose has been maintained at <110 mg/dL.
gh
caloriesse
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t
©
Fat 15%-30%
ed <30% of 2.5 g/kg/d Limited benefit to fat dose >30% nonprotein calories.
20
.R
of nonprotein nonprotein When administered separately from PN, infusion should be completed
09
calories calories
ep
within 12 hours.
M
Protein 0.8-2 g/kg/d ro
1-1.5 g/kg/d 2 g/kg/d Provided as high biologic value (ie, content high in essential AAs).
cM on
du Dose should be modified in conditions of renal and hepatic disease to the
ah in
ct lowest dose needed to achieve positive nitrogen balance.
i
on w
Renal failure
Pu ol
Chronic RF, no dialysis: 0.6-0.8 g/kg/day.
bl e o
Chronic RF, hemodialysis, or peritoneal dialysis: 1.2-1.3 g/kg/day.
is
h
RF, continuous hemofiltration: 1 g/kg/day.
hi
Acute RF: Balanced mixture of essential/nonessential AAs.
ng n p
Acute RF with severe MN or hypercatabolic state: 1.5-1.8
r
G art
g/kg/day.
i
ro
Liver failure
up wit
Protein restriction should be used for acute management of hepatic
un ho
encephalopathy but not for chronic use.
Specialized AA formulations indicated only in chronic encephalopathy
le ut
ss
unresponsive to pharmacotherapy.
ot rm
Fat (lipids) Prevention of 1%-2% of Contraindicated in patients with pancreatitis induced by hyperlipidemia.
he
pe
essential fatty caloric dose as Withhold doses for triglyceride level >400 mg/dL.
rw sio
acid deficiency linoleic acid and
is
0.5% of caloric
is
e
dose as α-
no s p
linolenic acid.
n
t e ro h
i
d.
AA, amino acid; MN, malnutrition; PN, parenteral nutrition; RF, renal failure
Based on references 1, 3, 4, and 12.
ib
i te
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16 17

10. Protein end-stage renal disease who received dialysate contami-
A
• ↑ renal solute load nated with aluminum has been reported.19
• azotemia ll Since aluminum is ubiquitous, it is very difficult, if not
ri
gh
Co
• impaired renal function impossible, to remove it from products used in the prepara-
ts
py
• acidosis tion of PN.19 As a result, the FDA proposed a set of regula-
re
ri
Total tions, which went into effect on July 26, 2004, requiring
gh
se calories manufacturers to label products used in the PN preparation
rv
t
©
Liver process with their aluminum content (Table 6, page 22).5,20
Fat ed
20
The purpose is to stimulate the manufacturers of PN prod-
.R
• fatty infiltration
• ↑ serum triglycerides
09
• ↑ aspartate ucts to prepare products with lower aluminum content and
• impaired pulmonary function ep aminotransferase
M
to inform clinicians of the aluminum content of PN prod-
ro
cM on
• altered immunologic function • ↑ alanine
du
ucts.20 The FDA also sought to establish a maximum safe
• hepatobiliary disease aminotransferase
ah in
ct
limit of aluminum loads at 5 mcg/kg body weight per day.5
i
• ↑ alkaline
on w
Although aluminum is present in products other than PN
phosphatase
(heparin, albumin), these products are not included in the
Pu ol
• hepatomegaly
regulation.20 For PN, salts of calcium and phosphorus have
bl e o
• cholestasis
is
h
the highest aluminum content.19
hi
Dextrose Compared with adults, neonates/pediatric patients
ng n p
Hyperglycemia require higher doses, on a body weight basis, of calcium
r
G art
i
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• serum glucose >200 mg/dL and phosphorus to ensure both growth and mainte-
up wit
• hyperinsulinemia nance.18 Neonates also have less ability to renally excrete
• impaired phagocytosis and excess aluminum loads.19 ASPEN released a statement
un ho
neutrophil chemotaxis advising clinicians to identify patients at greatest risk of
le ut
ss
Pulmonary Function developing aluminum toxicity and attempt to minimize
• ↑ CO2 production and minute
ot rm
aluminum intake in these patients.18-20
ventilation
he
pe
• respiratory failure in patients
rw sio
PN Formulation Design
with limited reserve
is
Formulations of PN are extremely complex products
is
e
• prolonged mechanical
no s p
ventilation intended for I.V. use. Careful consideration of nutrient dose
n
t e ro h
and avoidance of unstable or incompatible ingredients are
i
Figure 3. Consequences
d.
necessary. Inconsistent compounding practices have led to
of protein calorie overfeeding. serious harm in patients receiving PN.3 In an effort to provide
CO2, carbon dioxide consistent, specific guidelines for PN, the National Advisory
Based on references 1, 4, 13, and 14.
ib
i
continued on page 23
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d.
18 19

11. Table 5. Micronutrients: PN Dosing Guidelines
A
Normal Daily Requirements Usual Daily Doses
Na, K ll 1-2 mEq/kg Individualize, variable.
ri
gh
Co
Cl, acetate As needed for acid–base balance Equal amounts as sodium or potassium salt.
ts
py
Electrolytes
Phosphorus 20-40 mmol
re
ri
gh
Calcium
se 10-15 mEq Gluconate salt preferred for PN. Stability limited by concentration
rv
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of calcium and phosphorus.
©
ed
20
Magnesium 8-20 mEq
.R
09
ep
M
ro
Thiamin (B1) 6 mg Provided by addition of multiple vitamin injection product.
cM on
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Riboflavin (B2) 3.6 mg FDA mandated reformulation of vitamin products to increase
thiamine, folic acid, pyridoxine, and ascorbic acid.
ah in
Niacin (B3) 40 mg
ct
i
Monitor warfarin carefully during transition to
on w
Folic acid 600 mcg products with vitamin K.
Pu ol
Pantothenic acid 15 mg
bl e o
Vitamins
Pyridoxine (B6) 6 mg
is
h
hi
Cyanocobalamin (B12) 5 mcg
ng n p
Biotin 60 mcg
r
G art
Ascorbic acid 200 mg
i
ro
up wit
Vitamin A 3,300 IU
Vitamin D 200 IU
un ho
Vitamin E 10 IU
le ut
ss
Vitamin K 150 mcg
ot rm
Chromium 10-15 mcg Use manganese with caution in patients with an obstructed
he
Trace Elements
biliary tract.
pe
Copper 0.3-0.5 mg
rw sio
Accumulation may result in neurologic toxicity.
is
Manganese 60-100 mcg Zinc requirements increase with high GI output.
is
e
Zinc 2.5-5.0 mg Selenium is indicated for long-term care and critically ill patients.
no s p
Patients on long-term PN are prone to iron deficiency. Iron status
n
t e ro h
Selenium 20-60 mcg should be assessed initially and every 3 months in these patients.
i
d.
Iron Not routinely added
GI, gastrointestinal; PN, parenteral nutrition
ib
Based on references 3, 4, 16, and 17.
i te
d.
20 21

12. Table 6. FDA Requirements Group on Standards and Practice Guidelines for Parenteral
For Labeling Aluminum Content
A
Nutrition published “Safe Practices for Parenteral Nutrition.”
ll
Of PN Products
These guidelines provide recommendations for the PN label
ri
gh
Co
and order, as well as PN compounding, compatibility, stabili-
Large-volume parenterals Must contain ≤ 25 mcg/L
ts
py
• Concentrated dextrose, amino of aluminum. ty, and administration.3 They call for a standardized PN label
re
ri
acids, parenteral lipids, sterile format to promote correct interpretation of PN contents
gh
se
water for injection, saline, and across all health care environments; describe the pharma-
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electrolyte solutions
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cist’s duty to review the PN formula to ensure it is complete
ed
20
and balanced, and will be stable and compatible upon
.R
09
Small-volume parenterals and 1. Must be labeled with admixture; and include admixture processes and quality
pharmacy bulk packages
ep
the maximum level of
M
control requirements that foster safe and accurate com-
ro
• Electrolyte salts of calcium, aluminum in the product
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phosphorus, potassium, at expiration. pounding of PN formulas (Table 7, pages 26-29).3,6
ah in
ct
magnesium, and sodium 2. If reconstituted, must be In addition, pharmacists should refer to the revised USP
i
labeled with the maximum
on w
• Multivitamins General Chapter <797> “Pharmaceutical Compounding—
level of aluminum at expiration
• Trace elements Sterile Preparations” (official as of June 1, 2008) for poli-
Pu ol
in the reconstituted form.
bl e o
3. Maximum amount of cies and procedures on the handling of sterile
is
h
aluminum may be preparations.6 USP chapter <797> provides mandates for
hi
determined by any of
the compounding of sterile products at 5 levels of risk
ng n p
the following methods:
based on the probability of exposing patients to microbial
r
• Highest level measured in
G art
i
ro
batches over the last 3 years. or physical contaminants, as well as specific requirements
up wit
• Highest level for the last for environmental quality and control and personnel
5 batches. cleansing and garbing.
un ho
• Maximum historical level.
Using the “Safe Practices” format for a patient with renal
le ut
ss
failure receiving hemodialysis,caloric doses do not need to
ot rm
Based on reference 5. be modified, but doses of protein, potassium, magnesium,
he
phosphorus, and acetate require adjustment (see Figure 4
pe
rw sio
for an example of a standard order form filled out for a
is
renal failure patient; see Figure 5 for an example of a stan-
is
e
no s p
dard PN label for renal failure dosing; pages 30-31). The
n
t e ro h
label format allows for evaluation of nutrient dose based
i
d.
on body weight and literature recommendations.4
Recent interest in standard PN formulations is the result
of The Joint Commission National Patient Safety Goal 3b,
ib
i
continued on page 24
te
d.
22 23