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

ISRCTN	ISRCTN87144826
DOI	https://doi.org/10.1186/ISRCTN87144826
Secondary identifying numbers	N/A

Submission date: 23/02/2005
Registration date: 24/02/2005
Last edited: 16/05/2011

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Not provided at time of registration

Study website

Contact information

Dr Peter John Dawson Andrews
Scientific

Anaesthetics, Intensive Care & Pain Medicine
University of Edinburgh
Western General Hospital
Crewe Road
Edinburgh
EH4 2XU
United Kingdom

Study information

Study design	2 x 2 factorial pragmatic multicentre double-blind randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Available to downlaod for each of the recruiting sites in https://www.charttrials.abdn.ac.uk/signet/pis.php
Scientific title
Study acronym	SIGNET Trial
Study hypothesis	This prospective, multicentre, pragmatic, placebo-controlled trial examines whether the inclusion of the amino acid glutamine or additional selenium, or the two together, improve the outcome of critically ill patients, when given as part of parenteral nutrition support. The main outcomes are infections, mortality, length of hospital and ICU stay. An economic evaluation is an integral component of this trial.
Ethics approval(s)	Not provided at time of registration
Condition	Critically ill patients in intensive care
Intervention	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 glutamine), 2000 kcal daily 3. Standard PN bag, 12.5 g nitrogen, 2000 kcal daily, 500 mcg selenium daily 4. PN bag, 12.5 g nitrogen (including 20.2 g glutamine), 2000 kcal daily, 500 mcg selenium daily
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Nitrogen, glutamine, selenium
Primary outcome measure	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 outcome measures	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.
Overall study start date	01/01/2004
Overall study end date	30/04/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	500
Participant 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.
Participant 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.
Recruitment start date	01/01/2004
Recruitment end date	30/04/2009

Locations

Countries of recruitment

Scotland
United Kingdom

Study participating centre

Anaesthetics, Intensive Care & Pain Medicine

Edinburgh
EH4 2XU
United Kingdom

Sponsor information

NHS Lothian - University Hospitals Division (UK)
Hospital/treatment centre

Research & Development Office
Royal Infirmary of Edinburgh
51 Little France Crescent
Edinburgh
EH16 4SA
Scotland
United Kingdom

"ROR"	https://ror.org/03q82t418

Funders

Funder type

Government

Chief Scientist Office of the Scottish Executive Health Department

No information available

Fresenius Kabi

No information available

Oxford Nutrition

No information available

Medical Research Council (MRC) (UK) (G0401633)
Government organisation / National government

Alternative name(s): Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	17/03/2011		Yes	No