Randomised trial of glutamine and selenium supplemented parenteral nutrition for critically ill patients. Protocol Version 9, 19 February 2007 known as SIGNET Scottish Intensive care Glutamine or seleNium Evaluative TrialReport as inadecuate




Randomised trial of glutamine and selenium supplemented parenteral nutrition for critically ill patients. Protocol Version 9, 19 February 2007 known as SIGNET Scottish Intensive care Glutamine or seleNium Evaluative Trial - Download this document for free, or read online. Document in PDF available to download.

Trials

, 8:25

First Online: 20 September 2007Received: 10 July 2007Accepted: 20 September 2007DOI: 10.1186-1745-6215-8-25

Cite this article as: Andrews, P.J., Avenell, A., Noble, D.W. et al. Trials 2007 8: 25. doi:10.1186-1745-6215-8-25

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 and 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

AbbreviationsSIGNETS cottish I ntensive care G lutamine or seleN ium E valuative T rial

PNParenteral Nutrition

ENEnteral Nutrition

EUEuropean Union

ICUIntensive Care Unit

CCUCritical Care Unit

UKUnited Kingdom

DeptDepartment

RCTRandomised Controlled Trial

CIConfidence Interval

RRRelative Risk

LFTsLiver Function Tests

NHSNational Health Service

APACHEAcute Physiology and Chronic Health Evaluation

SOFASequential Organ failure Assessment

ggram

μgmicrogram

kcalkilocalorie

mlmillilitres

Kgkilogram

SF-12Short Form 12

EQ-5DEuoquol 5D 29

ISDInformation and Statistics Division Scotland

ONSNational Office of Statistics

GPGeneral Practitioner

SSARSuspected Serious Adverse Reaction

SUSARSuspected Unexpected Serious Adverse Reactions

QALYsquality adjusted life years

SICSScottish Intensive Care Society

ChaRTCentre for Healthcare Randomised Trial

GCPGood clinical practise

LRECLocal research ethics committee

RECResearch ethics committee

CRFCase report form

SOPStandard operating procedure

MHRAMedicines and Healthcare products Regulatory Agency

DMCData monitoring committee

TSCTrial steering committee

MRCMedical Research Council

Electronic supplementary materialThe online version of this article doi:10.1186-1745-6215-8-25 contains supplementary material, which is available to authorized users.

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Author: Peter JD Andrews - Alison Avenell - David W Noble - Marion K Campbell - Claire G Battison - Bernard L Croal - William 

Source: https://link.springer.com/







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