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Comparison of triple phase and lipid only intra-dialytic parenteral nutrition and survival and outcomes in malnourished haemodialysis patients to assess complications.

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.

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12608000123347
Acronym
IDPN and nutrition in HD
Enrollment
30
Registered
2008-03-07
Start date
2008-08-01
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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?

Interventions

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.

Sponsors

Austin Health
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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

Exclusion criteria

Malignancy Associated disease compromising 3 month survival

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026