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| Name | Class |
|---|---|
| Baxter Healthcare Corporation | INDUSTRY |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Care | Other | 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. |
|
| Supplemental PN | Experimental | Supplemental PN to complete inadequate EN provision
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Supplemental PN | Other |
| ||
| Standard Care |
| Measure | Description | Time Frame |
|---|---|---|
| Total energy amount delivered | 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. | First 7 days of the study period |
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Inclusion Criteria:
Patients in intensive care who meet all of the following:
Admitted to intensive care between 48 hours and 72 hours previously
Mechanically ventilated at the time of enrollment and expected to remain ventilated until the day after tomorrow
At least 16 years of age
Have central venous access suitable for PN solution administration
Have 1 or more organ system failure (respiratory, cardiovascular or renal) related to their acute illness defined as:
Partial pressure of oxygen (PaO2) / Fraction of Inspired oxygen (FiO2) ratio ≤ 300 mmHg
Currently on 1 or more continuous vasopressor infusion which were started at least 4 hours ago at a minimum dose of :
Renal dysfunction defined as
In patients without known renal disease:
serum creatinine > 171 mmol/l OR
Currently receiving renal replacement therapy
In patients with known renal disease:
an absolute increase of > 50% in creatinine from baseline OR
Currently receiving renal replacement therapy
Currently has an intracranial pressure monitor or ventricular drain in situ
Currently receiving extracorporeal membrane oxygenation
Currently has a ventricular assist device
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Alfred Hospital | Melbourne | Victoria | 3004 | Australia | ||
| Geelong Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29361959 | Derived | Ridley EJ, Davies AR, Parke R, Bailey M, McArthur C, Gillanders L, Cooper DJ, McGuinness S; Supplemental Parenteral Nutrition Clinical Investigators. Supplemental parenteral nutrition versus usual care in critically ill adults: a pilot randomized controlled study. Crit Care. 2018 Jan 23;22(1):12. doi: 10.1186/s13054-018-1939-7. | |
| 26703919 |
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|
| Geelong |
| Australia |
| Auckland City Hospital (CVICU) | Auckland | New Zealand |
| Auckland City Hospital (DCCM) | Auckland | New Zealand |
| Christchurch Hospital | Christchurch | New Zealand |
| Wellington Hospital | Wellington | New Zealand |
| Ridley EJ, Davies AR, Parke R, Bailey M, McArthur C, Gillanders L, Cooper DJ, McGuinness S; Supplemental Parenteral Nutrition Clinical Investigators. Supplemental parenteral nutrition in critically ill patients: a study protocol for a phase II randomised controlled trial. Trials. 2015 Dec 24;16:587. doi: 10.1186/s13063-015-1118-y. |
| ID | Term |
|---|---|
| D009102 | Multiple Organ Failure |
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D012769 | Shock |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |
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| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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