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Supplemental Parenteral Nutrition in Critically Ill Adults: A Pilot Randomised Controlled Trial

NCT01847534 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2016-08-02

No results posted yet for this study

Summary

One of the essential treatments for assisting patients in their recovery from illness is the provision of nutrition in a liquid form which is delivered into the stomach or as a fluid into the vein. Until recently the benefits of nutrition were undervalued in the critically ill, however, it has now become clear that targeted nutrition can positively affect a person's outcome. This is particularly important for patients who are significantly unwell and require increased amounts of nutrition to support recovery. Inadequate nutrition therapy leads them to rapidly lose weight, predominantly in the form of muscle loss which greatly contributes to their poor recovery.

Whilst nutrition is essential for recovery, there are several issues with the delivery of nutrition via the stomach (the most commonly used method of delivering nutrition in the critically ill). For many reasons, patients are unable to tolerate large quantities of nutrition via the stomach and in addition to this there are hospital or procedural reasons for nutrition being turned off for lengthy periods of time. As such, this results in patients being delivered only about half of the nutrition that is planned. One potential way to overcome this is to deliver nutrition via the vein, whilst nutrition into the stomach continues, with the aim to meet the energy gap that is lost by inadequate nutrition via the stomach.

In this study of 100 patients, we will deliver combined nutrition via the vein and stomach in 50 patients and the other 50 patients will receive nutrition as per normal practice. We will measure important outcomes for these patients to determine if this allows us to meet significantly more of their nutrition needs. This study will also help us determine how best to design a larger study of this strategy.

Conditions

  • Multiple Organ Failure
  • Critical Illness

Interventions

OTHER

Supplemental PN

OTHER

Standard Care

Sponsors & Collaborators

  • Baxter Healthcare Corporation

    collaborator INDUSTRY

  • Australian and New Zealand Intensive Care Research Centre

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2016-01-31
Completion
2016-07-31

Countries

  • Australia
  • New Zealand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01847534 on ClinicalTrials.gov