Randomised trial of glutamine and selenium supplemented parenteral nutrition (PN) for critically ill patients

Conditions

Critically ill patients in intensive care Not Applicable

Andrews PJ, Avenell A, Noble DW, Campbell MK, Croal BL, Simpson WG, Vale LD, Battison CG, Jenkinson DJ, Cook JA, Scottish Intensive care Glutamine or seleNium Evaluative Trial Trials Group.

2011-03-17173 citations

10.1136/bmj.d1542

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 PJ, Avenell A, Noble DW, Campbell MK, Battison CG, Croal BL, Simpson WG, Norrie J, Vale LD, Cook J, de Verteuil R, Milne AC, Trials Management Group.

2007-09-2025 citations

10.1186/1745-6215-8-25

Interventions

Allocation will be to one of four groups for 7 days: 1. Standard parenteral nutrition (PN) bag, 12.5 g nitrogen, 2000 kcal daily, no glutamine or selenium 2. PN bag, 12.5 g nitrogen (including 20.2 g

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Any patient on intensive care unit (ICU) requiring PN (and expected to have at least half of daily nutritional requirements given by that route) will be eligible for entry into the trial.

Exclusion criteria

Exclusion criteria: 1. As the study is based in adult ICUs, occasional patients aged under 16 years of age will be excluded. 2. We also exclude pregnant women; and people with severe hepatic failure, severe metabolic acidosis or severe renal insufficiency based on contraindications to glutamine in the product information sheet.

Design outcomes

Primary

Measure	Time frame
1. Infections - counted as participants with new infection(s) in the first 14 days (based on the expected duration of effect and the length of follow-up in previous trials), using published methods (infections based on Centers for Disease Control criteria) 2. Mortality - on ICU and overall at six months 3. Acute hospital and ICU length of stay	—

Secondary

Measure	Time frame
Days of antibiotic use; adverse events (see below); duration of PN use; alive, ventilator-free days as recommended by Rubenfield (26); patient quality of life measured by SF36 and EQ5D; costs to NHS, patients and carers/families; incremental cost per day in ICU saved and/or per quality adjusted life year (QALY). Data on all expected and unexpected adverse events, their severity and likelihood of causality by trial TPN are collected following a standard protocol, developed for the pilot (see enclosed PDF file). Once the trial office is informed of a Suspected Serious Adverse Reaction (SUSAR), it is reported to the MHRA within 7 days (none occurred during the pilot). Details of any SUSARs and Serious Suspected Adverse Reactions (SSARs) will also be provided in an annual safety report to the MHRA.	—

Measure

Time frame

Days of antibiotic use; adverse events (see below); duration of PN use; alive, ventilator-free days as recommended by Rubenfield (26); patient quality of life measured by SF36 and EQ5D; costs to NHS, patients and carers/families; incremental cost per day in ICU saved and/or per quality adjusted life year (QALY). Data on all expected and unexpected adverse events, their severity and likelihood of causality by trial TPN are collected following a standard protocol, developed for the pilot (see enclosed PDF file). Once the trial office is informed of a Suspected Serious Adverse Reaction (SUSAR), it is reported to the MHRA within 7 days (none occurred during the pilot). Details of any SUSARs and Serious Suspected Adverse Reactions (SSARs) will also be provided in an annual safety report to the MHRA.

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Countries

United Kingdom

Outcome results

None listed