Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000123347
Ethics application status
Not yet submitted
Date submitted
7/01/2008
Date registered
7/03/2008
Date last updated
7/03/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of triple phase and lipid only intra-dialytic parenteral nutrition and survival and outcomes in malnourished haemodialysis patients to assess complications.
Scientific title
Randomised blinded trial to compare triple phase and lipid only intra-dialytic parenteral nutrition in malnourished haemodialysis patients to assess survival, complications and improvements in nutrition.
Universal Trial Number (UTN)
Trial acronym
IDPN and nutrition in HD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malnourished haemodialysis patients 2662 0
Condition category
Condition code
Renal and Urogenital 2781 2781 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Malnourished haemodialysis patients will be randomised to 1000kcal 20% lipid ClinOleic Intra-Dialytic Parenteral Nutrition (IDPN) solution given via the dialysis line during the dialysis session 3 x week for up to 3 months.
Intervention code [1] 2403 0
Treatment: Drugs
Comparator / control treatment
1000kcal of triple phase parenteral nutrition solution containing lipid, amino acids and dextrose given via the dialysis line during the dialysis session 3 x week for up to 3 months
Control group
Active

Outcomes
Primary outcome [1] 3668 0
complications- survival, hyper-hypoglycaemia, fluid overload
Timepoint [1] 3668 0
3 months
Secondary outcome [1] 6197 0
increase in body mass using Colonial WCS-200 with Ranger 5000 weighing scales and body composition using Fresenius Body Composition Monitor H02-201-1
Timepoint [1] 6197 0
3 months
Secondary outcome [2] 6198 0
improved serum albumin using the BCP (BromoCresol Purple)method of measuring serum albumin
Timepoint [2] 6198 0
3 months
Secondary outcome [3] 6199 0
improved scored patient generated subjective global assessment (PG-SGA)
Timepoint [3] 6199 0
3 months

Eligibility
Key inclusion criteria
Haemodialysis patients who had been dialyzing at Austin Health for more than 3 months will be asked to participate in the study when they present with at least 2 of the following five criteria of malnutrition
1. Body Mass Index (BMI) <20
2. Weight loss >10% in 6 months
3. Serum albumin < 30
4. Prealbumin <300mg/l
5. normalised protein catabolic rate (nPCR) <1g/kg per day
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Malignancy
Associated disease compromising 3 month survival

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)
Haemodialysis patients who meet the criteria will be asked to participate and on signing the consent form will be randomly allocated to treatment groups by contacting the holder of the allocation schedule "off site"
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Using a randomisation table from a statistic book subjects will be allocated by third party by phone on recruitment to the treatment groups
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
2 groups
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 525 0
3084

Funding & Sponsors
Funding source category [1] 2919 0
Hospital
Name [1] 2919 0
Austin Health
Country [1] 2919 0
Australia
Funding source category [2] 2930 0
Self funded/Unfunded
Name [2] 2930 0
Country [2] 2930 0
Primary sponsor type
Hospital
Name
Austin Health
Address
Austin Health
Studley Rd
Heidelberg VIC 3104
Country
Australia
Secondary sponsor category [1] 2636 0
None
Name [1] 2636 0
Address [1] 2636 0
Country [1] 2636 0
Other collaborator category [1] 222 0
Individual
Name [1] 222 0
Dr Peter Mount
Address [1] 222 0
Nephrology Department
Austin Health
Studley Rd
Heidelberg VIC 3084
Country [1] 222 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 4861 0
Austin Health Human Research Ethics Commitee
Ethics committee address [1] 4861 0
PO Box 5000
Heidelberg VIC 3081
Ethics committee country [1] 4861 0
Australia
Date submitted for ethics approval [1] 4861 0
15/01/2008
Approval date [1] 4861 0
Ethics approval number [1] 4861 0

Summary
Brief summary
Several formulations have been used for IDPN and have ranged from those with minimal provision of nutrients to those that deliver significant amounts of calories and amino acids. Administration of lipid was originally considered to be contraindicated in IDPN but studies suggest otherwise and lipids are now used routinely. Austin Health is the first dialysis centre in the world to use standard lipid only IDPN solution. Since then a 20% lipid 500 ml or 30% lipid 250 ml solutions are routinely used in our haemodialysis patients requiring IDPN support. What effect if any is this practice having? Would the use of a more standardised practice of protein, lipid and dextrose combined solution be more beneficial?
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28265 0
Address 28265 0
Country 28265 0
Phone 28265 0
Fax 28265 0
Email 28265 0
Contact person for public queries
Name 11422 0
Karen Manley
Address 11422 0
Nutrition and Dietetics Department
Studley Rd
Heidelberg VIC 3084
Country 11422 0
Australia
Phone 11422 0
+61 3 94965011
Fax 11422 0
+61 3 94963168
Email 11422 0
karen.manley@austin.org.au
Contact person for scientific queries
Name 2350 0
Karen Manley
Address 2350 0
Nutrition and Dietetics Department
Studley Rd
Heidelberg VIC 3084
Country 2350 0
Australia
Phone 2350 0
+61 3 94965011
Fax 2350 0
+61 3 94963168
Email 2350 0
karen.manley@austin.org.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
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Documents added automatically
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