Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609001043224
Ethics application status
Not yet submitted
Date submitted
23/11/2009
Date registered
7/12/2009
Date last updated
7/12/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
Management of Refeeding Syndrome in Critical Illness: An Australasian Society of Parenteral and Enteral Nutrition (AuSPEN) Endorsed Multi-centre Phase II Randomised Controlled Trial.
Scientific title
In Critically Ill patients with Refeeding-related Hypophosphataemia, does energy restricted nutritional support compared with Standard/Usual care affect Intensive Care Unit (ICU) free days. A Phase II multi-centre randomised controlled trial.
Secondary ID [1] 1157 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Nutrition - Refeeding-related Hypophosphatemia 252250 0
Condition category
Condition code
Diet and Nutrition 252438 252438 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Protocol directed and energy restricted nutritional support during management of refeeding-related hypophosphataemia. Protocol currently under development by management committee and will be based on review of best available evidence.
Intervention code [1] 241582 0
Treatment: Other
Comparator / control treatment
Standard/usual care, which encompasses all aspects of standard/usual care delivered for the entire duration of Intensive Care Unit (ICU) stay.
Control group
Active

Outcomes
Primary outcome [1] 253312 0
Number of Days spent outside the Intensive Care Unit (ICU), also known as ICU Free days. Assessed and defined by the National Heart, Lung and Blood Institute Acute Respiratory Distress Syndrome Clinical Trials Network Investigators (Schoenfeld DA, Bernard GR for the Acute Respiratory Distress Syndrome (ARDS) Network. Statistical Evaluation of ventilator-free days as an efficacy measure in clinical trials of treatments for acute respiratory distress syndrome. Crit Care Med 2002;30:1772-1777).
Timepoint [1] 253312 0
Measured at day 90 post randomisation into the trial
Secondary outcome [1] 262378 0
Immune Function. Assessed by prospectively observing and recording measures of immune function (CD4, CD8, NK cell counts) in enrolled patients on each day of Intensive Care Unit (ICU) stay.
Timepoint [1] 262378 0
Measured during ICU stay
Secondary outcome [2] 262379 0
Infectious complications. Assessed by prospectively observing and recording infectious complications in enrolled patients on each day of Intensive Care Unit (ICU) stay.
Timepoint [2] 262379 0
Measured during ICU stay
Secondary outcome [3] 262380 0
Need for antibiotics. Assessed by prospectively observing and recording antibiotics delivered to enrolled patients on each day of Intensive Care Unit (ICU) stay.
Timepoint [3] 262380 0
Measured during ICU stay
Secondary outcome [4] 262381 0
Quality of Life assessed using the Short Form (SF)-36 questionnaire
Timepoint [4] 262381 0
Measured at day 90 post randomisation into the trial
Secondary outcome [5] 262382 0
Physical function assessed using the physical function component of the Short Form (SF)-36 questionnaire
Timepoint [5] 262382 0
Measured at day 90 post randomisation into the trial

Eligibility
Key inclusion criteria
Patients will be considered eligible for the trial is all of the following inclusion criteria are met at the time of screening: 1)Presence of refeeding hyphosphataemia (a serum phosphate drop of more than 0.16mmol/l from a previous reading to below 0.65mmol/L within 72 hours of the onset of nutritional support, 2)Age at least 18 years, 3) ICU specialist intends to manage the patient with continued normal nutritional support
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be considered ineligible for the trial if any of the following exclusion criteria are met at the time of screening: 1)Intensive Care Unit (ICU) discharge anticipated on day of screening or day after screening, 2)Diabetic ketoacidosis, 3)Presence of acute or chronic renal failure, 4)Admitted to the Intensive Care Unit (ICU) for palliative care only and not expected to survive hospital discharge, 5)Moribund and not expected to survive 24 hours, 6)Brain dead or suspected to be brain dead, or 7)Admitted to the study Intensive Care Unit (ICU) directly from another Intensive Care Unit (ICU).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Centralised randomisation by computer using a password protected webserver.
As in any centralised method, individual patient treatment assignment will not be revealed until the potential participant is determined to be truely eligible for the trial and patient identifiers are submitted over the web.
Persons recruiting patients into the trial will not be able to predict or influence treatment assignments, hence concealing treatment allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised (SAS)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
348
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 244062 0
Government body
Name [1] 244062 0
National Health and Medical Research Council(NHMRC)
Country [1] 244062 0
Australia
Primary sponsor type
Government body
Name
National Health and Medical Research Council (NHMRC)
Address
GPO Box 1421,
Canberra, ACT
2601
Country
Australia
Secondary sponsor category [1] 251408 0
None
Name [1] 251408 0
Address [1] 251408 0
Country [1] 251408 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 258161 0
Ethics committee address [1] 258161 0
Ethics committee country [1] 258161 0
Date submitted for ethics approval [1] 258161 0
23/10/2009
Approval date [1] 258161 0
Ethics approval number [1] 258161 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30535 0
Address 30535 0
Country 30535 0
Phone 30535 0
Fax 30535 0
Email 30535 0
Contact person for public queries
Name 13782 0
Dr Gordon Doig
Address 13782 0
Royal North Shore Hospital (RNSH) Intensive Care Unit (ICU), Pacific Highway St Leonards, NSW 2065.
Country 13782 0
Australia
Phone 13782 0
+61 2 99268656
Fax 13782 0
Email 13782 0
gdoig@med.usyd.edu.au
Contact person for scientific queries
Name 4710 0
Dr Gordon Doig
Address 4710 0
Royal North Shore Hospital (RNSH) Intensive Care Unit (ICU), Pacific Highway St Leonards, NSW 2065.
Country 4710 0
Australia
Phone 4710 0
+61 2 99268656
Fax 4710 0
Email 4710 0
gdoig@med.usyd.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseRestricted versus continued standard caloric intake during the management of refeeding syndrome in critically ill adults: A randomised, parallel-group, multicentre, single-blind controlled trial.2015https://dx.doi.org/10.1016/S2213-2600%2815%2900418-X
N.B. These documents automatically identified may not have been verified by the study sponsor.