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Trial registered on ANZCTR


Registration number
ACTRN12612000916842
Ethics application status
Not yet submitted
Date submitted
24/08/2012
Date registered
28/08/2012
Date last updated
28/08/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Examining the use of intravenous nutrition support during dialysis to improve the appetite of dialysis patients who are suffering from malnutrition
Scientific title
Intradialytic parental nutrition and appetite in malnourished haemodialysis patients: Does ClinOleic 20% have an appetite stimulating effect?
Secondary ID [1] 281087 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Haemodialysis in patients with kidney failure 287240 0
Malnutrition in patients with kidney failure 287241 0
Condition category
Condition code
Diet and Nutrition 287565 287565 0 0
Other diet and nutrition disorders
Renal and Urogenital 287566 287566 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
500mls ClinOleic 20% Intradialytic Parental Nutrition will be administered whilst each subject is undergoing routine thrice-weekly haemodialysis. The IDPN bag will be connected by a tube to the venous chamber of the dialysis machine and the IDPN solution will be infused over the 4 hour dialysis session. Patients will receive the IDPN infusion during each dialysis session (three times a week) for 12 weeks. Blood pressure, blood glucose and tryglceride levels will be monitored during the period of the intervention.
Intervention code [1] 285539 0
Treatment: Other
Comparator / control treatment
Standard care- dietary advice and oral nutritional supplements prescribed by dietitian (one on one) to meet energy and protein requirements
Control group
Active

Outcomes
Primary outcome [1] 287819 0
The patients serum albumin level will be recorded when the monthly blood tests are taken (all haemodialysis patients ordinarilly have a monthly blood test which measures serum albumin level)
Timepoint [1] 287819 0
0, 1, 2, 3 and 6 months
Secondary outcome [1] 298880 0
Appetite measured by the Visual analogue scale
Timepoint [1] 298880 0
0, 1, 2, 3 and 6 months
Secondary outcome [2] 298881 0
Fasting blood samples will be taken to measure changes in appetite hormones such as acyl-ghrelin, leptin, gastric inhibitory peptide (GIP), glucagon-like peptide-1 (GLP-1), cholecystokinin (CCK), peptide YY (pYY), neuropeptide Y (NPY), adiponectin, and insulin-like growth factor-1 (IGF-1). Blood samples will be centrigfuged to obtain plasma which will be stored at -80C for batch analysis. Acyl-ghrelin, GLP-1, CCK, pYY and IGF-1 will be analysed at established laboratories in Adelaide. ELISA kits will be used for NPY, leptin and adiponectin.
Timepoint [2] 298881 0
0, 3 months
Secondary outcome [3] 298882 0
Fasting blood samples will be taken to measure changes in inflammatory cytokines such as interleukin (IL) -2, IL-6,and tumor necrosis factor alpha (TNF-a). Blood samples will be centrigfuged to obtain plasma which will be stored at -80C for batch analysis. Cytokine kits (ELISA) will be used for the analysis.
Timepoint [3] 298882 0
0, 3 months
Secondary outcome [4] 298883 0
DEXA scans of lean body and fat mass
Timepoint [4] 298883 0
0, 3, 6 months
Secondary outcome [5] 298884 0
Quality of life KD-QOL Survey
Timepoint [5] 298884 0
0, 3, 6 months
Secondary outcome [6] 298885 0
Normalised protein nitrogen appearance will be calculated from midweek dialysis serum urea levels. The patients will have this blood test as part of their routine monthly blood tests (normally blood is taken prior to and after a mid week dialysis session).
Timepoint [6] 298885 0
0, 1, 2, 3, 6 months
Secondary outcome [7] 298886 0
Weight measured in kilograms
Timepoint [7] 298886 0
0, 1, 2, 3, 6 months
Secondary outcome [8] 298887 0
Patient-generated subjective global assessment will be undertaken by a dietitian (dietitian assessment tool for malnutrition)
Timepoint [8] 298887 0
0, 3, 6 months
Secondary outcome [9] 298888 0
Hospitalisations will be recorded from the medical notes, inclueding the number of admissions and number of days in hospital
Timepoint [9] 298888 0
6 months

Eligibility
Key inclusion criteria
Undergoing maintenance haemodialysis AND
BMI 19.8-22.9 plus serum albumin 25>35g/L or body weight loss 5-10% past 6 months
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Not undergoing maintenance haemodialysis, BMI< 19.8 or > 22.9, serum albumin >35g/L with < 5% body weight loss in the past 6 months, serum albumin <25g/L with body weight loss >10% in the past 6 months, egg or soy allergy, uncontrolled or untreated diabetes mellitus, Type I diabetes, diagnosis of malignancy, active infection, uncontrolled cardiac failure, liver failure, pancreatic insufficiency or other non-renal reason for malnutrition

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)
Participants will be screened to check they meet the inclusion criteria and then enrolled in study. Patients will be assigned a study number (sequentially) and allocated treatment according to the randomisation sequence generated.
The randomisation sequence will be concealed and the allocation of treatment will only be revealed once the study number has been allocated to the patient. In order to obtain the treatment allocation the study dietitian will contact the holder of the allocation schedule (off-site) via interstate phone call.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation sequence will be generated using www.randomisation.com
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Investigators undertaking data input and analysis will be blinded to treatement allocation
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

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

Funding & Sponsors
Funding source category [1] 285872 0
Self funded/Unfunded
Name [1] 285872 0
Address [1] 285872 0
Country [1] 285872 0
Australia
Primary sponsor type
Hospital
Name
Central Northern Adelaide Renal and Transplant Unit
Address
Level 9, East Wing, Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 284697 0
University
Name [1] 284697 0
University of South Australia
Address [1] 284697 0
Frome St
Adelaide SA 5000
Country [1] 284697 0
Australia
Other collaborator category [1] 277034 0
Individual
Name [1] 277034 0
Anthony Meade
Address [1] 277034 0
Central Northern Adelaide Renal and Transpant Unit
Level 9, East Wing, Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
Country [1] 277034 0
Australia
Other collaborator category [2] 277035 0
Individual
Name [2] 277035 0
Dr Shilpa Jesudason
Address [2] 277035 0
Central Northern Adelaide Renal and Transpant Unit
Level 9, East Wing, Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
Country [2] 277035 0
Australia
Other collaborator category [3] 277036 0
Individual
Name [3] 277036 0
Dr David Jesudason
Address [3] 277036 0
Endocrine Unit, Queen Elizabeth Hospital,
28 Woodville Road, Woodville West SA 5011
Country [3] 277036 0
Australia
Other collaborator category [4] 277037 0
Individual
Name [4] 277037 0
Dr Juan Jesus Carrero
Address [4] 277037 0
Division Renal Medicine,
Karolinksa Institutet,
Solnavagen 1, Solna,
Alfred Nobels Alle 8, Huddinge,
Stockholm
Sweden

Postal address:
SE-171 77 Stockholm Sweden
Country [4] 277037 0
Sweden

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 287901 0
Royal Adelaide Hospital Ethics Committee
Ethics committee address [1] 287901 0
IMVS building, Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
Ethics committee country [1] 287901 0
Australia
Date submitted for ethics approval [1] 287901 0
29/08/2012
Approval date [1] 287901 0
Ethics approval number [1] 287901 0

Summary
Brief summary
Malnutrition is a critical issue affecting the quality of life of patients with end-stage kidney failure on dialysis, and is associated with chronic inflammation, adverse patient outcomes and increased death. Nutritional support is highly important in this patient group, but often oral supplements are insufficient to correct the malnourished state. Intradialytic parenteral nutrition (IDPN) is intravenous nutrition supplementation which is given during dialysis treatments. IDPN has had some promising effects on appetite, food intake, body weight and other markers of nutritional health, but needs to be studied more closely particularly before patients develop severe malnutrition. This multidisciplinary, collaborative project aims to compare IDPN versus standard dietetic input (control group) in malnourished dialysis patients, and look at the effect on a comprehensive range of key markers of nutrition and patient quality of life. We aim to address this important clinical problem, to obtain evidence for new therapeutic approaches to improve patient outcomes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34614 0
Address 34614 0
Country 34614 0
Phone 34614 0
Fax 34614 0
Email 34614 0
Contact person for public queries
Name 17861 0
Anthony Meade
Address 17861 0
C/- level 6 Renal Consulting Area, Emergency Block, Royal Adelaide Hospital, North Tce, Adelaide, SA 5000
Country 17861 0
Australia
Phone 17861 0
+61 8 8222 0984
Fax 17861 0
+61 8 8222 5135
Email 17861 0
Anthony.Meade@health.sa.gov.au
Contact person for scientific queries
Name 8789 0
Alwyn Todd
Address 8789 0
University of South Australia
Frome St
Adelaide SA 5000
Country 8789 0
Australia
Phone 8789 0
+61 8 8302 9937
Fax 8789 0
Email 8789 0
alwyn.todd@unisa.edu.au

No information has been provided regarding IPD availability
Summary results
No Results