Patrick Ball

Hazards of parenteral treatment: do particles count?

After prolonged parenteral nutrition a 12 month old infant died with pulmonary hypertension and granulomatous pulmonary arteritis. A review of necropsy findings in 41 infants who had been fed parenterally showed that two of these also had pulmonary artery granulomata, while none of 32 control patients who died from sudden infant death syndrome had similar findings. Particulate contaminants have been implicated in the pathogenesis of such lesions and these were quantified in amino acid/dextrose solutions and fat emulsions using automated particle counting and optical microscope counting respectively. Parenteral feed infusions compounded for a 3000 g infant according to standard nutritional regimens were found to include approximately 37,000 particles between 2 and 100 microns in size in one days feed, of which 80% were derived from the fat emulsion. In-line end filtration of intravenous infusions may reduce the risk of particle associated complications. A suitable particle filter is required for use with lipid.

Intravenous in-line filters: filtering the evidence.

&NA; When all the available information is considered, and the role of filters in particulate contamination, in‐line chemical precipitates, identifying problems in parenteral therapy practice, microbial contamination and entrapped air is examined, the case for routine use appears strong. Purpose of review The routine use of intravenous in‐line filters on infusion lines has been controversial for many years, with strong advocates, detractors and many fence‐sitting observers. The purpose of this review was to examine the literature for new developments and to cast the net a little wider than in previous reviews in an attempt to draw useful parallels. Recent findings There were recent major policy statements or recommendations from a working party of the British Pharmaceutical Nutrition Group and from the US Centres for Disease Control. The first was focussed on filters and was broadly in favour, the second was not focussed on the subject but made quite a strong statement against, on microbiological issues alone. The major purpose of filters, however, is particulate contamination, and whilst there was little in the literature directly on this subject, useful parallels could be drawn from papers describing the therapeutic use of particles and also from their effects in intravenous drug users.

A prospective study of catheter-related complications in HPN patients.

BACKGROUND & AIMS Central venous access device (CVAD)-related complications such as catheter-related sepsis, occlusion and breakage contribute to both mortality and morbidity in home parenteral nutrition (HPN) patients. Prospectively collected data in these patients are scarce. METHODS Data on all CVAD-related complications in four tertiary referral centres in Australia and New Zealand were prospectively collected between 01/01/2009 and 31/12/2009 together with costs of each episode that required admission. RESULTS Of 53 patients (42 adults and 11 children), 27 suffered a total of 49 episodes of CVAD-associated complications (line infection 36, catheter blockage 5, line fracture 1, line migration 7), giving an incidence of 3.6 per 1000 CVAD days (11.6 per 1000 in patients with a multi-use CVAD). Thirty seven episodes resulted in hospital admission for a median duration of 8 days (range 1-29). Responsible microbes were mainly enteric with klebsiella being the most commonly isolated organism (10 episodes). The average cost of care per episode of CVAD-associated complication requiring inpatient admission was

AuSPEN clinical practice guideline for home parenteral nutrition patients in Australia and New Zealand

A9,710 (€6480 approximately). CONCLUSION CVAD complications, in particular line infection are still a major source of potentially avoidable HPN morbidity and mortality with a high cost to the healthcare system. The predominance of enteric organisms in our series raises the possibility of bacterial translocation as a significant component of the pathogenesis of line sepsis in HPN patients.

Portable bedside microcomputer system for management of parenteral nutrition in all age groups.

OBJECTIVE Evidence based guidelines for home parenteral nutrition (HPN) were commissioned by the Australasian Society of Parenteral and Enteral Nutrition (AuSPEN) and developed by a multidisciplinary group. The guidelines make recommendations in four domains: patient selection, patient training, formulation and monitoring regimens, and preventing and managing complications. METHODS The Appraisal of Guidelines Research and Evaluation guideline process was used to focus questions and identify evidence by systematic literature reviews of meta-analyses and randomized control trials in the Cochrane Library, Medline, Embase, and Cinahl to mid-2007. Where no randomized control trial evidence was found, the search was broadened to observational studies and expert opinion from related national and international guidelines as assessed by a validated appraisal process. RESULTS Selection of patients must assess individual risk/benefit and medical ethics. Patient training should be undertaken within a structured framework. Access devices should be selected for lowest risk of complications, including occlusion, sepsis, and breakage and be managed by early diagnosis and treatment. HPN should be formulated according to individual patient requirements by professionals with relevant skills and training. Pumps and ancillary products should conform to quality standards. Other intravenous medications may be prescribed provided these are reviewed for compatibility and effects on metabolic status. CONCLUSION Overall there is a lack of randomized control trials to provide high-quality evidence-based guidance but graded recommendations can be made. Multidisciplinary teams in centers with HPN management expertise are required for optimal care. This guideline should improve outcomes and quality of life for HPN patients in Australia and New Zealand.

Basic principles for compounding all-in-one parenteral nutrition admixtures.

A microcomputer program has been designed to provide comprehensive assistance to the clinician in prescribing parenteral nutrition in children of all ages. It is implemented on a fully portable, independent machine that can be taken to the bedside anywhere in the hospital. The user is guided through a standardised prescribing process based on a well tried protocol and taking into account the patients age, clinical condition, concurrent parenteral infusions, laboratory findings, and enteral intake. A printout is produced for insertion into the patients clinical record, giving all concerned in the care of the child a clear, legible record of when, how, and by whom the prescription was calculated. The user can review and amend the proposed prescription before printing, giving ultimate control to the prescriber, not the computer. The system saves time by performing accurately the necessary calculations, and provides financial savings by reducing wastage of parenteral nutrition during the re-introduction of enteral feeding.

Nutraceuticals--a pharmaceutical viewpoint: part II.

Parenteral nutrition admixtures are complex pharmaceutical entities. The more closely they are examined, the more physico-chemical interactions emerge that could potentially affect stability. The move towards large scale hospital or commercial preparation, with a requirement for extended shelf life, and the increasing use of admixtures as vehicles for drugs and pharmaconutrients have created new formulation challenges for pharmaceutical scientists.

Diagnosis and management of postural orthostatic tachycardia syndrome: A brief review.

Purpose of reviewTo review pharmaceutical and pharmacological issues relating to the benefits and risks associated with the use of naturally sourced nutraceuticals when administered singly or in combinations. Recent findingsThe application of vegetable extracts or dietary supplementation with selenium or antioxidant vitamins results in positive benefits on immunity and other phenomena associated with chronic diseases, ageing and cancer. However, there appear to be no cardiovascular benefits from vitamin mixtures, which may in fact cause harm. Therefore, although recent publications have increased our understanding of the metabolic actions of nutraceuticals, learning to use them to the best advantage is going to require products with uniform and consistent quality. Unfortunately, a single purified substance will not always have the same antioxidant activity, nor provide the same clinical benefits as nutraceutical mixtures and combinations occurring in natural extracts. In order to perform first-class clinical studies to determine safety and efficacy, the stability, compatibility and other pharmaceutical variables inherent in many of these combination products will have to be better controlled. SummaryNutraceuticals have potent biological actions. Their use is increasing dramatically, and there is growing evidence of clinical benefits. No medicinal products are completely safe so their risks need to be characterized and controlled. Imposing pharmaceutical levels of control and regulation would increase costs and reduce patient access to new products, but the evidence is compelling that closer monitoring of raw materials, processing and formulation will be required to maximize the benefits and minimize the risks.

Particulate Contamination in Parenteral Nutrition Solutions: Still a Cause for Concern?

Postural orthostatic tachycardia syndrome (POTS) has been recognized since at least 1940. A review of the literature identifies differences in the definition for this condition and wide variations in treatment and outcomes. This syndrome appears to describe a group of conditions with differing pathophysiology, which requires treatment tailored to the true underlying disorder. Patients need to be fully evaluated to guide treatment. Further research is required to effectively classify the range of underlying pathophysiology that can produce this syndrome and to guide optimal management.

Australasian Society for Parenteral and Enteral Nutrition guidelines for supplementation of trace elements during parenteral nutrition

OBJECTIVES In consideration of a US Federal Drug Administration recommendation that all parenteral nutrition admixtures should be administered through an in-line filtration device, this observational study examined the number, size distribution, and sources of particulate contamination in parenteral nutrition admixture infusion systems. METHODS Samples were drawn from the terminal connection of the infusion tubing before connection to the patient. The particles were sized and counted by optical microscopy and further investigated by electron microscopy and energy disperse spectroscopy. RESULTS Large numbers of particles were found, and information gained about their possible origin. CONCLUSIONS This study provides further support for the adoption of this Federal Drug Administration recommendation.