Condition category
Not Applicable
Date applied
23/02/2005
Date assigned
24/02/2005
Last edited
16/05/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

https://www.charttrials.abdn.ac.uk/signet/index.php

Contact information

Type

Scientific

Primary contact

Dr Peter John Dawson Andrews

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

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

Not provided at time of registration

Study design

2 x 2 factorial pragmatic multicentre double-blind randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Available to downlaod for each of the recruiting sites in https://www.charttrials.abdn.ac.uk/signet/pis.php

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

Phase

Not Applicable

Drug names

Nitrogen, glutamine, selenium

Primary outcome measures

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 trial start date

01/01/2004

Overall trial end date

30/04/2009

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

500

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

United Kingdom

Trial participating centre

Anaesthetics, Intensive Care & Pain Medicine
Edinburgh
EH4 2XU
United Kingdom

Sponsor information

Organisation

NHS Lothian - University Hospitals Division (UK)

Sponsor details

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

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

Chief Scientist Office of the Scottish Executive Health Department

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Fresenius Kabi

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Oxford Nutrition

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Medical Research Council (MRC) (UK) (G0401633)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21415104

Publication citations

  1. Results

    Andrews PJ, Avenell A, Noble DW, Campbell MK, Croal BL, Simpson WG, Vale LD, Battison CG, Jenkinson DJ, Cook JA, , Randomised trial of glutamine, selenium, or both, to supplement parenteral nutrition for critically ill patients., BMJ, 2011, 342, d1542.

Additional files

Editorial Notes