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)

Peter J. D. Andrews, Alison Avenell, David W. Noble, Marion K. Campbell, Claire G. Battison, Bernard Lewis Croal, William G. Simpson, John David Norrie, Luke D. Vale, Jonathon Cook, Robyn De Verteuil, Anne Catherine Milne, Trials Management Group

Research output: Contribution to journalArticle

25 Citations (Scopus)

Abstract

Background: Mortality 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/design: 2 x 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. Discussion: To 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.

Discussion: To 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 registration: This trial is registered with the International Standard Randomised Controlled Trial Number system.

Original languageEnglish
Article number25
Number of pages14
JournalTrials
Volume8
DOIs
Publication statusPublished - 20 Sep 2007

Keywords

  • abdominal-surgery
  • nitrogen-balance
  • unit
  • nutrients
  • illness
  • muscle
  • spread
  • trace
  • cost

Cite this

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). / Andrews, Peter J. D.; Avenell, Alison; Noble, David W.; Campbell, Marion K.; Battison, Claire G.; Croal, Bernard Lewis; Simpson, William G.; Norrie, John David; Vale, Luke D.; Cook, Jonathon; De Verteuil, Robyn; Milne, Anne Catherine; Trials Management Group.

In: Trials, Vol. 8, 25, 20.09.2007.

Research output: Contribution to journalArticle

Andrews, Peter J. D. ; Avenell, Alison ; Noble, David W. ; Campbell, Marion K. ; Battison, Claire G. ; Croal, Bernard Lewis ; Simpson, William G. ; Norrie, John David ; Vale, Luke D. ; Cook, Jonathon ; De Verteuil, Robyn ; Milne, Anne Catherine ; Trials Management Group. / 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). In: Trials. 2007 ; Vol. 8.
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abstract = "Background: Mortality 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/design: 2 x 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. Discussion: To 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.Discussion: To 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 registration: This trial is registered with the International Standard Randomised Controlled Trial Number system.",
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author = "Andrews, {Peter J. D.} and Alison Avenell and Noble, {David W.} and Campbell, {Marion K.} and Battison, {Claire G.} and Croal, {Bernard Lewis} and Simpson, {William G.} and Norrie, {John David} and Vale, {Luke D.} and Jonathon Cook and {De Verteuil}, Robyn and Milne, {Anne Catherine} and {Trials Management Group}",
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T1 - Randomised trial of glutamine and selenium supplemented parenteral nutrition for critically ill patients

T2 - Protocol version 9, 19 February 2007 known as SIGNET (Scottish Intensive Care Glutamine or seleNium Evaluative Trial)

AU - Andrews, Peter J. D.

AU - Avenell, Alison

AU - Noble, David W.

AU - Campbell, Marion K.

AU - Battison, Claire G.

AU - Croal, Bernard Lewis

AU - Simpson, William G.

AU - Norrie, John David

AU - Vale, Luke D.

AU - Cook, Jonathon

AU - De Verteuil, Robyn

AU - Milne, Anne Catherine

AU - Trials Management Group

PY - 2007/9/20

Y1 - 2007/9/20

N2 - Background: Mortality 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/design: 2 x 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. Discussion: To 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.Discussion: To 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 registration: This trial is registered with the International Standard Randomised Controlled Trial Number system.

AB - Background: Mortality 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/design: 2 x 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. Discussion: To 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.Discussion: To 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 registration: This trial is registered with the International Standard Randomised Controlled Trial Number system.

KW - abdominal-surgery

KW - nitrogen-balance

KW - unit

KW - nutrients

KW - illness

KW - muscle

KW - spread

KW - trace

KW - cost

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DO - 10.1186/1745-6215-8-25

M3 - Article

VL - 8

JO - Trials

JF - Trials

SN - 1745-6215

M1 - 25

ER -