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

Primary Purpose

Multiple Organ Failure, Critical Illness

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Supplemental PN
Standard Care
Sponsored by
Australian and New Zealand Intensive Care Research Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Multiple Organ Failure

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

    1. Partial pressure of oxygen (PaO2) / Fraction of Inspired oxygen (FiO2) ratio ≤ 300 mmHg

    2. Currently on 1 or more continuous vasopressor infusion which were started at least 4 hours ago at a minimum dose of :

      1. Dopamine greater than 5 mcg/kg/min
      2. Noradrenaline ≥ 0.1mcg/kg/min
      3. Adrenaline ≥ 0.1 mcg/kg/min
      4. Any dose of total vasopressin
      5. Milrinone >0.25mcg/kg/min)

    3. Renal dysfunction defined as

      In patients without known renal disease:

      1. serum creatinine > 171 mmol/l OR

      2. Currently receiving renal replacement therapy

        In patients with known renal disease:

      3. an absolute increase of > 50% in creatinine from baseline OR
      4. Currently receiving renal replacement therapy
    4. Currently has an intracranial pressure monitor or ventricular drain in situ
    5. Currently receiving extracorporeal membrane oxygenation
    6. Currently has a ventricular assist device

Exclusion Criteria:

  • Both EN and PN cannot be delivered at enrollment (i.e. either an enteral tube or a central venous catheter cannot be placed or clinicians feel that EN or PN cannot be safely administered due to any other reason).
  • Currently receiving PN
  • Standard PN solutions cannot be delivered at enrolment (i.e. clinicians believe that a patient definitely needs a specific parenteral nutrition formulation (e.g. glutamine-supplementation or specific lipid formulation).
  • Death is imminent or deemed highly likely in the next 96 hours.
  • There is a current treatment limitation in place or the patient is unlikely to survive to 6 months due to underlying illness
  • More than 80% of energy requirements have been satisfactorily delivered via the enteral route in the last 24 hours.
  • Are known to be pregnant

Sites / Locations

  • The Alfred Hospital
  • Geelong Hospital
  • Auckland City Hospital (CVICU)
  • Auckland City Hospital (DCCM)
  • Christchurch Hospital
  • Wellington Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Standard Care

Supplemental PN

Arm Description

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 to complete inadequate EN provision Patients allocated to the supplemental PN (intervention) group will have PN commenced within 2 hours of randomisation. The starting dose of PN will be determined by the amount of energy received in the 24 hours prior to randomisation. EN will be managed as per local protocol however EN must not be reduced based on the supplemental PN being administered. The adequacy of nutrition provision from both PN and EN will be assessed at midday each day for 7 days or until ICU discharge. The dose of PN will be adjusted according to a prespecified schedule.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
April 22, 2013
Last Updated
July 31, 2016
Sponsor
Australian and New Zealand Intensive Care Research Centre
Collaborators
Baxter Healthcare Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01847534
Brief Title
Supplemental Parenteral Nutrition in Critically Ill Adults: A Pilot Randomised Controlled Trial
Official Title
Supplemental Parenteral Nutrition in Critically Ill Adults: A Pilot Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Australian and New Zealand Intensive Care Research Centre
Collaborators
Baxter Healthcare Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed Description
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Organ Failure, Critical Illness

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard Care
Arm Type
Other
Arm Description
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.
Arm Title
Supplemental PN
Arm Type
Experimental
Arm Description
Supplemental PN to complete inadequate EN provision Patients allocated to the supplemental PN (intervention) group will have PN commenced within 2 hours of randomisation. The starting dose of PN will be determined by the amount of energy received in the 24 hours prior to randomisation. EN will be managed as per local protocol however EN must not be reduced based on the supplemental PN being administered. The adequacy of nutrition provision from both PN and EN will be assessed at midday each day for 7 days or until ICU discharge. The dose of PN will be adjusted according to a prespecified schedule.
Intervention Type
Other
Intervention Name(s)
Supplemental PN
Intervention Type
Other
Intervention Name(s)
Standard Care
Primary Outcome Measure Information:
Title
Total energy amount delivered
Description
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.
Time Frame
First 7 days of the study period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 : Dopamine greater than 5 mcg/kg/min Noradrenaline ≥ 0.1mcg/kg/min Adrenaline ≥ 0.1 mcg/kg/min Any dose of total vasopressin Milrinone >0.25mcg/kg/min) 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: Both EN and PN cannot be delivered at enrollment (i.e. either an enteral tube or a central venous catheter cannot be placed or clinicians feel that EN or PN cannot be safely administered due to any other reason). Currently receiving PN Standard PN solutions cannot be delivered at enrolment (i.e. clinicians believe that a patient definitely needs a specific parenteral nutrition formulation (e.g. glutamine-supplementation or specific lipid formulation). Death is imminent or deemed highly likely in the next 96 hours. There is a current treatment limitation in place or the patient is unlikely to survive to 6 months due to underlying illness More than 80% of energy requirements have been satisfactorily delivered via the enteral route in the last 24 hours. Are known to be pregnant
Facility Information:
Facility Name
The Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Geelong Hospital
City
Geelong
Country
Australia
Facility Name
Auckland City Hospital (CVICU)
City
Auckland
Country
New Zealand
Facility Name
Auckland City Hospital (DCCM)
City
Auckland
Country
New Zealand
Facility Name
Christchurch Hospital
City
Christchurch
Country
New Zealand
Facility Name
Wellington Hospital
City
Wellington
Country
New Zealand

12. IPD Sharing Statement

Citations:
PubMed Identifier
29361959
Citation
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.
Results Reference
derived
PubMed Identifier
26703919
Citation
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.
Results Reference
derived

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

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