Abstract
BackgroundMortality rates in the Intensive Care Unit and subsequent hospital mortality rates in the UK remain high. Infections in Intensive Care are associated with a 2–3 times increased risk of death. It is thought that under conditions of severe metabolic stress glutamine becomes "conditionally essential". Selenium is an essential trace element that has antioxidant and anti-inflammatory properties. Approximately 23% of patients in Intensive Care require parenteral nutrition and glutamine and selenium are either absent or present in low amounts. Both glutamine and selenium have the potential to influence the immune system through independent biochemical pathways. Systematic reviews suggest that supplementing parenteral nutrition in critical illness with glutamine or selenium may reduce infections and mortality. Pilot data has shown that more than 50% of participants developed infections, typically resistant organisms. We are powered to show definitively whether supplementation of PN with either glutamine or selenium is effective at reducing new infections in critically ill patients.Methods/design2 × 2 factorial, pragmatic, multicentre, double-blind, randomised controlled trial. The trial has an enrolment target of 500 patients. Inclusion criteria include: expected to be in critical care for at least 48 hours, aged 16 years or over, patients who require parenteral nutrition and are expected to have at least half their daily nutritional requirements given by that route.Allocation is to one of four iso-caloric, iso-nitrogenous groups: glutamine, selenium, both glutamine & selenium or no additional glutamine or selenium. Trial supplementation is given for up to seven days on the Intensive Care Unit and subsequent wards if practicable. The primary outcomes are episodes of infection in the 14 days after starting trial nutrition and mortality. Secondary outcomes include antibiotic usage, length of hospital stay, quality of life and cost-effectiveness.DiscussionTo date more than 285 patients have been recruited to the trial from 10 sites in Scotland. Recruitment is due to finish in August 2008 with a further six months follow up. We expect to report the results of the trial in summer 2009.Trial registrationThis trial is registered with the International Standard Randomised Controlled Trial Number system. ISRCTN87144826
Highlights
Mortality rates in the Intensive Care Unit and subsequent hospital mortality rates in the UK remain high
Infections acquired on the Intensive care unit (ICU) have been associated with a two to three fold increased risk of death [3], this is associated with both illness and drug related impairment of the patient's immune system
Prior to the implementation of the EU Directive in 2004, the MHRA confirmed that the exemptions would be rolled over to a Clinical Trial Authorisation
Summary
In 2002, the Medicines Control Agency provided exemption letters for Selenase T pro injection (sodium selenite) supplied by Oxford Nutrition and for Dipeptiven supplied by Fresenius-Kabi for this trial. Efficient and economical provision of parenteral nutrition at recruiting centres required collaboration with a pharmacy holding a license to compound the investigational medicinal product. Participating pharmacy departments and the central supplier have access to a custom designed website that has information on stock inventory, its shelf life and site PN usage. When this is combined with a comprehensive, refrigerated delivery service and an emergency contract with a national courier, PN supply has become more efficient. Addition of selenium and electrolytes by the individual participating pharmacies allows SIGNET centres to recruit patients with only a 5 day stock of 2 "base" bags of PN. Μg microgram kcal kilocalorie ml millilitres Kg kilogram SF-12 Short Form 12 EQ-5D Euoquol 5D [29] ISD Information and Statistics Division (Scotland) ONS National Office of Statistics GP General Practitioner SSAR Suspected Serious Adverse Reaction
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