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

Completed

Conditions: Critically ill patients in intensive care
Not Applicable

Registration Number: ISRCTN87144826

Lead Sponsor: HS Lothian - University Hospitals Division (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 500

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

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)<br>2. Mortality - on ICU and overall at six months<br>3. Acute hospital and ICU length of stay

Secondary Outcome Measures

Name	Time	Method
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<br>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.