The effect of a low volume pharmaconutrition supplement with antioxidants and glutamine (Intestamine®) administration to critically ill patients on the prevalence of infection, ventilation requirements and duration of intensive care unit stay : a pilot study

Van Niekerk, Hester Susanna (Stellenbosch : University of Stellenbosch, 2010-12)

Thesis (MNutr (Interdisciplinary Health Sciences. Human Nutrition))--University of Stellenbosch, 2010.

Thesis

ENGLISH ABSTRACT: Introduction Complications of severe infection or acute trauma include a cascade of immunological dysfunctions known as SIRS (Systemic Inflammatory Response Syndrome), that affect response to treatment, prolonging and complicating the course of illness and jeopardizing clinical outcome. Timing and the nature of nutritional support in the Intensive Care Unit (ICU) setting may influence this process. Against this background, and despite some trials demonstrating beneficial clinical outcomes for the use of immune-modulating diets (IMD), the findings of the US summit on immune-enhancing enteral therapy concluded that the currently available enteral immune-enhancing formulas are “first-generation products” which may not be appropriate in patients with SIRS or severe sepsis. This highlights a need for alternative nutritional products that target the specific needs of this patient population. As such, Intestamin® is designed for use in severely stressed patients as an immune-modulating enteral feed supplement which aims to improve maintenance of gut barrier integrity and immune response. Aim The aim of this pilot study was to investigate the effect of Intestamin® administration to critically ill patients, and in particular, to determine if administration would impact on nosocomial infections, ventilation days and the length of stay in the ICU. Methods The study design was an open label, retrospective case control, analytical study, of patients admitted to the ICU in The Bay Hospital, Richards Bay, between January 2002 and November 2003, who received Intestamin®. Patients were selected for the study from post-surgery and post-trauma patients at high risk of sepsis and SIRS, and critically ill patients with manifested SIRS or severe sepsis. Development of respiratory and urinary sepsis was used as surrogate markers for progression to severe sepsis and SIRS. Additionally, duration of ventilation and ICU stay were considered representative of the response to treatment and degree of clinical complications. Results The findings of the study demonstrated a significant difference in the rates of respiratory infection(p=0.05), positive sputum and tracheal aspirate cultures(p=0.03) and urinary catheter tip cultures(p=0.04). with statistically lower rates in the intervention group compared to the control group. There were no significant differences in the rates of urinary tract infection, septicaemia or in combined sepsis rates between the two groups. There were statistically significant higher rates of positive pus cell counts in the sputum(p=0.003) and urine(p=0.01) in the intervention group, compared to the control group. No corresponding reduction in ventilation days or ICU stay was observed. Conclusion In this patient population, early enteral nutrition with specially formulated IMD, (Intestamin®), did result in a significant reduction in respiratory infections, but not in other types of sepsis, ICU or ventilator days in critically ill ICU patients. This positive finding in some, but not all endpoints collected, may reflect confounding factors in the small patient population or the choice of clinical endpoints, rather than a genuine limitation in the benefit. IMD remains a tantalizing and scientifically plausible intervention in this patient population, with larger clinical trials necessary to confirm outcomes. The study supports the safe use of Intestamin by the nasojejenal route in this patient population.

AFRIKAANSE OPSOMMING:Inleiding Komplikasies van erge infeksie of akute trauma sluit ‘n kaskade van immunologiese disfunsie in, bekend as SIRS (Sistemiese Inflammatoriese Respons Sindroom), wat die respons op behandeling affekteer, die verloop van siekte verleng en kompliseer asook die kliniese uitkoms beïnvloed. Tydsberekening en die aard van die voedingsondersteuning in die Intensiewe Sorg Eenheid (ISE) mag hierdie proses beinvloed. Teen hierdie agtergrond, en ten spyte van sommige studies wat die voordelige kliniese uitkoms vir die gebruik van immuun-modulerende diete (IMD) toon, het die “US summit” oor immuunverbeterde enterale terapie tot die gevolgtrekking gekom dat die huidige beskikbare enterale immuun-verbeterde formules, “eerste-generasie” produkte is, wat moontlik nie toepaslik is vir pasiente met SIRS of erge sepsis nie. Dit beklemtoon ’n behoefte aan alternatiewe voedingsprodukte wat die spesifieke behoeftes van die genoemde pasient populasie teiken. Intestamin® is ontwerp vir gebruik in erge gestresde pasiente as ‘n immuun-modulerende enterale voedingssupplement doelgerig om spysverteringskanaal integriteit te onderhou en immuniteit te verbeter. Doel Hierdie loodsstudie se doel was om die effek van Intestamin® toediening aan kritiek siek pasiente te ondersoek, spesifiek om vas te stel of die toediening impakteer op nosokomiale infeksies, ventilasie dae en dae in ISE. .Metode Die studie ontwerp was ‘n oop, retrospektiewe, geval kontrole, analitiese studie van pasiente opgeneem in die ISE van The Bay Hospital, Richardsbaai, tussen Januarie 2002 en November 2003, wat Intestamin® ontvang het. Pasiënte is geselekteer vir die studie uit post-chirurgies en post-trauma pasiente wat hoë risiko was vir sepsis en SIRS, en kritiek siek pasiente wat reeds manifisteer het met SIRS of erge sepsis. Ontwikkeling van respiratoriese en urinêre sepsis is gebruik as surrogaat merkers vir die progressie na erge sepsis en SIRS. Addisioneel is duur van ventilasie en ISE verblyf beskou as verteenwoordigend vir die respons op behandeling en die graad van kliniese komplikasies. Resultate Die bevindinge van die studie het betekenisvolle verskille aangedui in die voorkoms van respiratoriese infeksies(p=0.05), positiewe sputum en trachiale aspiraatkulture(p=0.03) en urine kateterpunt-kulture(p=0.04) met statistiese laer voorkoms in die intervensie groep in vergelyking met kontroles. Geen statistiese verskille in die voorkoms van urineweg-infeksies, septisemia of in gekombineerde sepsis voorkoms tussen die twee groepe is gevind nie. Daar was statistiese betekenisvolle hoër voorkoms van etterselle hoeveelhede in die sputum(p=0.030 en uriene(p=0.01) van die intervensie groep in vergelyking met die kontrole groep. Geen ooreenkomstige vermindering in ventilasie dae of ISE verblyf is opgemerk nie. Gevolgtrekking In hierdie pasiënt populasie, het vroeë enterale voeding met spesifieke geformuleerde IMD (Intestamin®), ‘n beduidende vermindering in respiratoriese infeksies getoon, maar nie in ander tipes sepsis, ISE of ventilasie dae by kritiek siek pasiente nie. Hierdie positiewe bevindinge in sommige. maar nie al die versamelde eindpunte nie, reflekteer moontlike bydraende faktore in die klein pasiënt populasie of die keuse van kliniese eindpunte, eerder as a ware beperking in die voordele. IMD bly steeds ‘n uitdagende en wetenskapilik uitsonderlike intervensie in hierdie pasiënt populasie, wat groter kliniese studies benodig om die uitkoms te bevestig. Die studie ondersteun die veilige gebruik van Intestamin® via die nasojejenale roete in kritiek siek pasiënte.

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