philpan1c

PhilSPEN Online Journal of Parenteral and Enteral Nutrition

(Article 22 | POJ_0015.html) Issue February 2012 - December 2014: 53-56

An Observational Study

Parenteral nutrition delivery from 24 to 48 hours: assessment of mixture status and patient response

Abstract | Introduction | Methodology | Results | Discussion | Conclusion | References | PDF (78 KB) |Back to Articles Page

Submitted: December 12, 2009 | Posted: July 29, 2014

AUTHORS:

Francisco Praire, MD; Luisito Llido, MD*

*Corresponding Author; Email: llido2001@gmail.com

INSTITUTION WHERE RESEARCH WAS CONDUCTED:

Clinical Nutrition Fellowship Training Program, St. Luke’s Medical Center, Quezon City, Metro-Manila, Philippines

 

ABSTRACT: | Back

Background: Due to the requirements of JCIA (Joint Commission International Accreditation) regarding parenteral nutrition (PN) delivery, the infection control services (ICS) of the institution issued a policy that based on CDC (Center for Diseases Control) guidelines all PN formulations should be given within 24 hours and the rest discarded, which is a very expensive and wasteful practice.

Objective: 1) To determine to what extent beyond 24 hours the “All in One” PN bags were delivered and 2) To determine adverse reactions on the patients’ part to the PN delivery when it extends beyond 24 hours.

Methodology: All records of parenteral nutrition (PN) delivery beyond 24 hours were retrieved from the clinical nutrition database. The following data were collected: a) total number of PN bags delivered beyond 24 hours, b) the manufacturer of the PN products, c) record of adverse reactions from the patient when the PN delivery went beyond 24 hours.

Results: 31 PN infusions were collected and monitored. The total PN volume delivered was 57,923 ml; total hours infused was 824 hours; volume delivered per ml was 70.3 ml per hour; the range of infusion duration was 27.5 hours to 32 hours. For the adverse events: no infection, no sepsis, (+) fever due to phlebitis in 2/31 (6.4%).

Conclusion: Three chamber parenteral nutrition (PN) bags can be delivered beyond 24 hours even reaching to 32 hours with minimum adverse events related to phlebitis and not to any infection or more serious cause(s).

Recommendation: It is recommended that the 24 hour hang-time restriction for three chamber PN bags be relaxed and extended to 48 hour hang time.

 

KEYWORDS: PN delivery, adverse reactions, beyond 24 hours

 

INTRODUCTION | Back

“All in one” parenteral nutrition (PN) solutions (or three chamber bags) when mixed have a wide range of delivery completion rates. One manufacturer recommends completion within 24 hours (as written in its product literature, Fresenius-Kabi or FK), (1) while another company claims stability and safety within 48 hours (BBraun or BB) (2). The clinical nutrition section through its nutrition team has been providing patients with parenteral nutrition for more than 24 hours per bag as needed since year 2000 (10 years practice experience) without any side effects related to infection, formula contamination, or deterioration.

Due to the requirements of JCIA (Joint Commission International Accreditation) that parenteral nutrition delivery be covered by guidelines, the infection control services (ICS) issued a policy that based on CDC (Center for Diseases Control) guidelines, all parenteral nutrition formulations should be given within 24 hours and the rest discarded. (3) The Clinical Nutrition Service and Nutrition Committee were not notified about this decision. Concerns regarding the wastage for the patient’s part as well as proof of validity of the decision were raised since this ran counter to the patient’s benefit (cost-effectiveness). Furthermore there was no study done to evaluate this matter.

To resolve the issue, the Clinical Nutrition Service reviewed cases of parenteral nutrition delivery from years 2007 to September 2009 since the memo on twenty-four (24) hour delivery was given in October 2009. The goal of the review was twofold: 1) to determine to what extent the “All in One” PN bags were delivered beyond twenty-four (24) hours and 2) to determine adverse reactions on the patients’ part to the PN delivery when it extends beyond 24 hours.

 

METHODOLOGY | Back

All records of parenteral nutrition (PN) delivery beyond 24 hours were retrieved from the clinical nutrition database. Parenteral nutrition means the following: a) "three in one bags" (delivered as one bag with protein, carbohydrate and lipid separated in chambers) with or without micronutrient supplementation, b) compounded parenteral nutrition containing protein, carbohydrate and lipids with or without micronutrient supplementation. The micronutrients were added separately after the macronutrient compartments were mixed. Most of these solutions had micronutrient supplementation ranging from water and fat soluble vitamins to trace elements. The following data were collected: a) total number of PN bags delivered beyond 24 hours, b) the manufacturer of the PN products, c) record of adverse reactions from the patient when the PN delivery went beyond 24 hours.

These are the adverse manifestations to be identified: a) Fever, chills, rashes, hypotension, shock; b) Infection pointing to the PN as source (by multidisciplinary disciplines); c) Sepsis attributed to the PN solution (by attending physicians); d) hematologic tests like CBC (leucocytosis) ordered in relation to observed reactions; e) Stopping PN delivery as recommended by medical staff based on clinical observations as to the patient’s status/reaction. (4)

Consecutive parenteral nutrition deliveries of more than twenty-four (24) hours were followed up from August 2009 to September 2009 and the data gathered. One clinical nutrition fellow was responsible for gathering all the data including the physical examination of the patients and adverse sites if there were any. The statistical data were expressed as percentages of the products per company, mean volume of PN delivered, mean duration of PN delivery per bag, and percentages of noted adverse reactions and/or interruptions of PN.


RESULTS | Back

A total of 31 PN bags were utilized and delivered for more than 24 hours within the study period. The data gathered are shown in Table 1.

pnuse2_tbl1

The observed adverse events or deviations from the usual delivery of the PN solutions are shown in Table 2).

pnuse2_tbl2

 

DISCUSSION: | Back

The current technology of delivering parenteral nutrition has changed. Before the advent of three chamber bags, the macronutrients were mixed through a compounding system, which had to be in a sterile environment to protect the mixture from contamination thus making it safe for the patient. The drawback was the added cost plus some break(s) in the “clean” technique during the actual delivery from the pharmacy-compounding unit through the nursing unit and finally to the patient. Thus it mandated a delivery time of 24 hours. Today the macronutrients in the three chamber bags are separated by a seal done in a sterile environment in one bag, which was only broken when the final admixture of the PN solution was to be given. There is no external handling upon usage allowing for longer periods of delivery without the previous problem of contamination. Thus the issue of “break in technique” as considered by the CDC (3) was already addressed through this improvement in technology making the twenty-four (24) hour infusion requirement rather restrictive resulting to increased wastage of these expensive products.

The result of this observational study bears the proof of the sterility and safety of these new three-in-one solutions where there was no observed serious adverse event in all the bags covered in the study. What is even noticeable is the absence of severe complications that lead to discontinuation of the PN delivery. The only noted adverse event was fever secondary to phlebitis, which occurred twice in the products of one company (BB: 9.5%; 6.4% over-all adverse rate for all PN bags). (Table 2) It is noted that the rate of infusion was higher in these products  (80 ml/hour) compared to the other product (FK: 50 ml/hour), (Table 1) thus leading to a shorter delivery duration and this rapid rate could have contributed to some hyperosmolar effects on the vein intima leading to phlebitis. (4) The delivery of these PN bags for more than twenty-four (24) hours reaching an average of twenty-seven (27) hours overall, with thirty-two (32) hours reached in one group (FK) without any major adverse events or problems as earlier enumerated, is evidence that the current PN bags can be safely delivered from beyond twenty-four (24) hours to as much as thirty (30) hours. A thirty five (35) hour delivery period would be within this safe time frame.


CONCLUSION: | Back

Three chamber parenteral nutrition (PN) bags can be delivered beyond twenty-four (24) hours even reaching to thirty-two (32) hours with minimum adverse events related to phlebitis and not to any infection or more serious cause(s).

RECOMMENDATION:

It is recommended that the twenty-four (24) hour hang-time restriction for three chamber parenteral nutrition (PN) bags be relaxed and extended to thirty five (35) hours hang time.

 

REFERENCES: | Back

    1. Parenteral nutrition. Fresenius-Kabi. Available at: http://www.fresenius-kabi.com/160.htm. Accessed December 10, 2009.
    2. Clinical Nutrition. BBraun. Available at http://www.bbraun.com/cps/rde/xchg/bbraun-com/hs.xsl/products.html. Accessed December 10, 2009.
    3. CDC. Summary of Recommended Frequency of Replacements for Catheters, Dressings, Administration Sets, and Fluids. Available in http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5110a3.htm. Accessed November 10, 2009.
    4. Mirtallo J et al. Safe practices of parenteral nutrition. JPEN 2004 Supplement; 28 (6): S39-S70.

     

Abstract | Introduction | Methodology | Results | Discussion | References | Back to Articles Page