Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
408 participants
INTERVENTIONAL
2017-11-23
2022-05-01
Brief Summary
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Detailed Description
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Supplemental parenteral nutrition will be discontinued when a patient is well enough to be discharged from hospital or when the patients attending clinician determines a central line is no longer needed for standard care. There is no maximum duration of supplemental parenteral nutrition..
Adherence to the study intervention will be monitored via medical chart reviews during site monitoring visits, and data queries on individual patient case report form documentation.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Standard Care
The control group in this study is pragmatic standard nutrition care. Currently after a bone marrow transplant in Australia, patients are normally fed orally for as long as possible. If oral intake fails to provide sufficient calories for a period of two to three days, enteral or parenteral nutrition may be provided.
Pragmatic standard care.
Nutrition support will be provided as per usual care.
Early supplemental parenteral nutrition
Supplemental prophylactic early parenteral nutrition will be commenced 1 day prior to conditioning chemoradiotherapy in patients who are not already malnourished. Supplemental parenteral nutrition continues throughout conditioning chemoradiotherapy and stem cell transplant.
The dose of supplemental parenteral nutrition will be dependent on the total calories also received from oral and/or enteral nutrition intake.
Parenteral nutrition.
Nutrition support will be provides as per usual, but oral and enteral intake will be topped up with a standard parenteral nutrition solution. The standard parenteral nutrition solution will contain approximately 40 grams of amino acids/L, 40 g lipids/L and 100g dextrose/L).
Pragmatic standard care.
Nutrition support will be provided as per usual care.
Interventions
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Parenteral nutrition.
Nutrition support will be provides as per usual, but oral and enteral intake will be topped up with a standard parenteral nutrition solution. The standard parenteral nutrition solution will contain approximately 40 grams of amino acids/L, 40 g lipids/L and 100g dextrose/L).
Pragmatic standard care.
Nutrition support will be provided as per usual care.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patients with a documented licensing contraindication to parenteral nutrition.
18 Years
ALL
No
Sponsors
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Australasian Bone Marrow Transplant Recipient Registry
UNKNOWN
University of Roma La Sapienza
OTHER
Northern Clinical School Intensive Care Research Unit, University of Sydney
UNKNOWN
University of Sydney
OTHER
Responsible Party
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Principal Investigators
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Gordon S Doig, PhD
Role: PRINCIPAL_INVESTIGATOR
Northern Clinical School Intensive Care Research Unit, University of Sydney
Locations
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Royal North Shore Hospital
Sydney, New South Wales, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Christchurch Hospital, CDHB
Christchurch, , New Zealand
Countries
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Central Contacts
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Facility Contacts
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Site Investigator
Role: primary
Site Investigator
Role: primary
Site Investigator
Role: primary
Other Identifiers
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ACTRN12615001329550
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1194-5952
Identifier Type: OTHER
Identifier Source: secondary_id
NHMRC APP1108301
Identifier Type: -
Identifier Source: org_study_id
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