Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000543280
Ethics application status
Approved
Date submitted
3/07/2009
Date registered
6/07/2009
Date last updated
6/07/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Does insulin have an anti-inflammatory effect in patients with end stage renal failure on haemodilaysis
Scientific title
Does insulin reduce inflammation in patients with end stage kidney disease during a haemodialysis session?
Secondary ID [1] 911 0
Cochrane Renal Group 070800147
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
End stage renal failiure 237152 0
Condition category
Condition code
Renal and Urogenital 237478 237478 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A randomised cross over study of a low dose insulin infusion (2 units/hr) during a standardised 4 hour haemodialysis session with a washout of 1 week between studies. The dialysis regime will remain unaltered between each session.
Intervention code [1] 236866 0
Treatment: Drugs
Comparator / control treatment
A standard 4 hour haemodialysis session without an insulin infusion.
Control group
Active

Outcomes
Primary outcome [1] 238281 0
Change in highly sensitive C reactive protein (hsCRP) as measured in plasma at baseline, 1 hour into the dialysis session, at 4 hours at the end of the dialysis session, 2 hours after the dialysis session and at 24 hours after dialysis.
Timepoint [1] 238281 0
Plasma highly sensitive C reactive protein (hsCRP) will be measured at baseline, 1 hr into dialysis, at 4 hours at the end of dilalysis, 2 hours post dialysis and 24 hours post dilalysis. HsCRP is measured by standard laboratory assay.
Primary outcome [2] 238282 0
Inflammatory cytokines (tumor necrosis factor (TNF), interleukin 6 (IL6)) will be measured at baseline, 1 hr into dialysis, at 4 hours at the end of dilalysis, 2 hours post dialysis and 24 hours post dilalysis..Cytokines measured by enzyme linked immunoabsorbent assay (ELISA).
Timepoint [2] 238282 0
Inflammatory cytokines will be measured at baseline, 1 hr into dialysis, at 4 hours at the end of dilalysis, 2 hours post dialysis and 24 hours post dilalysis.
Primary outcome [3] 238283 0
Changes in lipid peroxidation products measured in serum using standard assays.
Timepoint [3] 238283 0
Samples will be measured at baseline, 1 hr into dialysis, at 4 hours at the end of dilalysis, 2 hours post dialysis and 24 hours post dilalysis.
Secondary outcome [1] 244656 0
NIl
Timepoint [1] 244656 0
Nil

Eligibility
Key inclusion criteria
Stable non diabetic individuals on haemodialysis for at least 2 months.
No clinical evidence of an acute illness or inflammation.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inability to give informed consent.
Diabetic
Smoker
Intercurrent acute illness or inflammation.
Established cardiovascular disease

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 were recruited from the dialysis service.
Patients were randomly assigned to receive either dialysis with a continuous insulin infusion or to a conventional dialysis session and then subsequently switched over to the opposite treatment, with at least one week between each study. Allocation was concealed with a third party off site advising the dialysis nurses which treatment option was allocated.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization was achieved by use of a computerized randomization plan generator (www.randomization.com).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
6/08/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment outside Australia
Country [1] 1869 0
New Zealand
State/province [1] 1869 0

Funding & Sponsors
Funding source category [1] 237255 0
Charities/Societies/Foundations
Name [1] 237255 0
Otago Medical Research Foundation
Country [1] 237255 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
Great King Street
PO Box 913
Dunedin 9010
Country
New Zealand
Secondary sponsor category [1] 236741 0
Hospital
Name [1] 236741 0
Dunedin Hospital
Address [1] 236741 0
Great King Street
Private Bag
Dunedin 9010
Country [1] 236741 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239356 0
Lower South Regional Ethics Committee
Ethics committee address [1] 239356 0
PO Box 5849
Dunedin 9010
Ethics committee country [1] 239356 0
New Zealand
Date submitted for ethics approval [1] 239356 0
Approval date [1] 239356 0
06/08/2008
Ethics approval number [1] 239356 0

Summary
Brief summary
Individuals with Chronic kidney disease (CKD) requiring dialysis treatment have a high risk of cardiovascular disease. It is thought that the process of dialysis may contribute to this risk by increasing oxidative stress and inflammation. In addition, individuals with non-diabetic CKD have are insulin resistant, similar to individuals with pre-diabetes. Insulin has been demonstrated to have anti-inflammatory properties. In very sick patients in Intensive Care, continuous insulin infusions have been associated with better outcomes. The impact of an insulin infusion during a haemodialysis session to reduce the inflammation generated by dialysis has not been studied. We propose a pilot study of an insulin infusion during dialysis to see if markers of inflammation measured in the blood are reduced. If there is evidence of improvement, we would then propose a longer time study to really see if there is benefit from insulin therapy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29841 0
Address 29841 0
Country 29841 0
Phone 29841 0
Fax 29841 0
Email 29841 0
Contact person for public queries
Name 13088 0
Prof Robert Walker
Address 13088 0
Medical & Surgical Sciences
Dunedin School of Medicine
University of Otago
PO Box 913 Dunedin 9010
Country 13088 0
New Zealand
Phone 13088 0
64 3 4740999
Fax 13088 0
64 3 4747641
Email 13088 0
[email protected]
Contact person for scientific queries
Name 4016 0
Prof Robert Walker
Address 4016 0
Medical & Surgical Sciences
Dunedin School of Medicine
University of Otago
PO Box 913 Dunedin 9010
Country 4016 0
New Zealand
Phone 4016 0
64 3 4740999
Fax 4016 0
64 3 4747641
Email 4016 0
[email protected]

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No Supporting Document Provided



Results publications and other study-related documents

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