Supplemental Parenteral Nutrition in Critically Ill Adults: A Pilot Randomised Controlled Trial
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|ClinicalTrials.gov Identifier: NCT01847534|
Recruitment Status : Completed
First Posted : May 7, 2013
Last Update Posted : August 2, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Multiple Organ Failure Critical Illness||Other: Supplemental PN Other: Standard Care||Phase 2 Phase 3|
The principal objectives are:
- To determine whether the supplemental Parenteral Nutrition (PN) strategy leads to the delivery of increased amounts of total nutrition (measured as energy delivered), and is safe in regards to adverse effects.
To measure the clinical outcomes in patients receiving both study strategies to provide information to assist design of a larger randomized controlled trial.
Secondary objectives in a sub-set of patients are:
- To determine whether the supplemental PN strategy leads to improved nitrogen balance.
- To determine both the nutritional requirements and nutritional intake of critically ill patients during the period of hospitalization after transfer from the Intensive Care Unit (ICU).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Supplemental Parenteral Nutrition in Critically Ill Adults: A Pilot Randomised Controlled Trial|
|Study Start Date :||February 2014|
|Actual Primary Completion Date :||January 2016|
|Actual Study Completion Date :||July 2016|
Standard care: Nutrition will be managed as per best practice and local policy including the use of small bowel feeding tubes, prokinetics and PN if required to meet nutrition needs.
Other: Standard Care
Experimental: Supplemental PN
Supplemental PN to complete inadequate EN provision
Other: Supplemental PN
- Total energy amount delivered [ Time Frame: First 7 days of the study period ]The primary outcome for this pilot study is the total energy amount delivered from nutrition therapy (ie. from Enteral Nutrition (EN) and from supplemental PN, if delivered) over the first 7 days of the study period.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01847534
|The Alfred Hospital|
|Melbourne, Victoria, Australia, 3004|
|Auckland City Hospital (CVICU)|
|Auckland, New Zealand|
|Auckland City Hospital (DCCM)|
|Auckland, New Zealand|
|Christchurch, New Zealand|
|Wellington, New Zealand|