Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000704695
Ethics application status
Approved
Date submitted
31/10/2005
Date registered
2/11/2005
Date last updated
28/06/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Early PN trial
Scientific title
The effects of early parenteral nutrition compared to standard care on 60 day landmark mortality in the critically ill patient: A level I randomised
controlled trial.
Secondary ID [1] 280750 0
Nil
Universal Trial Number (UTN)
Trial acronym
Early PN trial®
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Critical Illness (ICU pts) 853 0
Condition category
Condition code
Diet and Nutrition 920 920 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will be rdx to receive early parenteral nutrition or standard care. Early PN will be initiated within 24 h of ICU admission at a rate to achieve approx 25-30kcals/kg per day. Early PN will be maintained until enteral nutrition (EN) is initiated. In this effectiveness trial, the duration of early PN will be PRN. The duration of standard care will be determined at the discretion of the attending physician (PRN), as long as the patient remains in the ICU.
Intervention code [1] 742 0
Treatment: Other
Comparator / control treatment
Standard (active) care
Control group
Active

Outcomes
Primary outcome [1] 1205 0
60 day all cause landmark mortality
Timepoint [1] 1205 0
Day 60
Secondary outcome [1] 2193 0
ICU and hospital length of stay
Timepoint [1] 2193 0
Measured at ICU and hospital discharge
Secondary outcome [2] 2194 0
SF1
Timepoint [2] 2194 0
Measured at day 60
Secondary outcome [3] 2195 0
Degree and days of organ dysfunction
Timepoint [3] 2195 0
Measured during ICU stay
Secondary outcome [4] 2196 0
Days of mechanical ventilation
Timepoint [4] 2196 0
Measured during ICU stay
Secondary outcome [5] 2197 0
Days of renal replacement therapy
Timepoint [5] 2197 0
Measured during ICU stay
Secondary outcome [6] 2198 0
Days of inotrope requirement
Timepoint [6] 2198 0
Measured during ICU stay
Secondary outcome [7] 2199 0
Daily blood glucose levels
Timepoint [7] 2199 0
Measured during ICU stay
Secondary outcome [8] 2200 0
Daily insulin dose
Timepoint [8] 2200 0
Measured during ICU stay
Secondary outcome [9] 2201 0
Duration and severity of pressure ulcers
Timepoint [9] 2201 0
Measured during ICU stay
Secondary outcome [10] 2202 0
Antibiotic usage
Timepoint [10] 2202 0
Measured during ICU stay
Secondary outcome [11] 2203 0
Measures of nutritional status
Timepoint [11] 2203 0
Measured during ICU stay

Eligibility
Key inclusion criteria
Patients will be screened for eligibility as soon as practical after admission to the study ICU. Patients will be considered eligible for the trial if the following criteria are addressed at the time of screening:Inclusion criteria: The patient is not currently receiving oral, enteral or parenteral nutritional support; The treating physician does not expect to begin oral, enteral or parenteral nutritional support within 24 hours.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The treating physician expects to discharge the patient from the ICU within 24 hours; The patient's ICU length of stay at time of screening is greater than 24 hours; Parenteral nutrition cannot be started within 24 hours of ICU admission; There is an absolute contraindication for enteral nutrition and the patient would normally be supported with parenteral nutrition (Ex. The patient receives chronic home PN); The patient is admitted to the ICU for treatment of thermal injury (burns); The patient is admitted to the ICU for palliative care; The patient is moribund and not expected to survive 24 hours; The patient is brain dead or suspected to be brain dead; The patient was admitted to the study ICU directly from another ICU; The treating physician believes there is an absolute contraindication to treatment received in either study arm.

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, password protected web-server. As in any centralised method (see examples of centralised phone/fax rdx) individual patient treatment assignment will not be revealed until the potential participant is determined to be truly 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.
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 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
21/09/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1470
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1015 0
Government body
Name [1] 1015 0
NHMRC
Country [1] 1015 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
Sydney, NSW 2006, Australia
Country
Australia
Secondary sponsor category [1] 878 0
None
Name [1] 878 0
Address [1] 878 0
Country [1] 878 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287558 0
Northern Sydney Health Human Research Ethics Committee
Ethics committee address [1] 287558 0
Ethics committee country [1] 287558 0
Australia
Date submitted for ethics approval [1] 287558 0
24/10/2005
Approval date [1] 287558 0
15/11/2005
Ethics approval number [1] 287558 0
0510-196M

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

Contacts
Principal investigator
Name 35433 0
Address 35433 0
Country 35433 0
Phone 35433 0
Fax 35433 0
Email 35433 0
Contact person for public queries
Name 9931 0
Dr. Gordon S. Doig
Address 9931 0
RNSH - ICU
Pacific Highway
St. Leonards,
NSW 2065
Country 9931 0
Australia
Phone 9931 0
02 9926 8656
Fax 9931 0
Email 9931 0
gdoig@med.usyd.edu.au
Contact person for scientific queries
Name 859 0
Dr. Gordon S. Doig
Address 859 0
RNSH - ICU
Pacific Highway
St. Leonards,
NSW 2065
Country 859 0
Australia
Phone 859 0
02 9926 8656
Fax 859 0
Email 859 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
No additional documents have been identified.