Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000507785
Ethics application status
Not yet submitted
Date submitted
30/04/2013
Date registered
8/05/2013
Date last updated
8/05/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Uremic pruritus: a clinical observational study of maintenance hemodialysis patients.
Scientific title
Uremic pruritus: a clinical observational study of maintenance hemodialysis patients (Cross sectional study).
Secondary ID [1] 282417 0
NIL
Universal Trial Number (UTN)
U1111-1142-4613
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pruritus in Hemodialysis Patient. 289004 0
Condition category
Condition code
Renal and Urogenital 289349 289349 0 0
Kidney disease

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Patients on Hemodialysis more than 3 months will be asked regarding any complaining of pruritus and if present then detail history and examination regarding the pruritus(like character, distribution, scar mark, itching mark, xerosis present or not, etc) and it's any relation with laboratory parameters (like haemoglobin, haematocrit, mean corpuscular volume, mean corpuscular haemoglobin, mean corpuscular haemoglobin concentration, reticulocytes, iron, ferritin, transferrin, transferrin saturation, urea, creatinine, calcium, phosphorus, albumin, total protein, PTH, Alkaline Phosphatase and glucose.)
Approximate duration of the examination 1-2 hour.
Intervention code [1] 287052 0
Not applicable
Comparator / control treatment
'No comparator/control group'
Control group
Uncontrolled

Outcomes
Primary outcome [1] 289458 0
The frequency of pruritus in hemodialysis patients and relationship with different clinical and laboratory parameters.

The patients' symptoms will be recorded before a mid-week HD session and a blood sample will be collected. The following laboratory tests will be performed: haemoglobin, haematocrit, mean corpuscular volume, mean corpuscular haemoglobin, mean corpuscular haemoglobin concentration, reticulocytes, iron, ferritin, transferrin, transferrin saturation, urea, creatinine, calcium, phosphorus, albumin, total protein, PTH, Alkaline Phosphatase and glucose.
Timepoint [1] 289458 0
- It's a cross sectional observational study.
- Including pstient who are on hemodialysis for more than 3 months.
Secondary outcome [1] 302535 0
NIL
Timepoint [1] 302535 0
NIL

Eligibility
Key inclusion criteria
- age 18 year and more.
- on maintenance HD attending HD units for more than 3 month
- Patients who are able to understand and complete questionnaires
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patients who have pruritus attributed to causes other than chronic kidney disease (CKD)
- Patients who have had significant alteration in their dialysis regimen within the 2 weeks prior to Screening (or those for whom such changes are anticipated during the study) are excluded. A "significant alteration" is defined as:
A change in the type of hemodialysis filter;
An increase or decrease in total duration of dialysis prescribed of > 1 hour/week;
A change in the site or type of venous access for dialysis;
An increase or decrease in prescribed blood flow of >100 mL/min;
Patients who are unwilling to comply with the study protocol.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Random sample
Timing
Prospective
Statistical methods / analysis
Pruritus and non-pruritus groups will compare according to the variables. Sample size calculated using Results from OpenEpi, Version 2, open source calculator--SSPropor. (taking DOPPS study where pruritus was found in 42% of patient within 18,801 HD patients). Confidence interval is 95%.
Student t-test and chi-squared tere will use for statistical analysis. Statistical significance is defined as p < 0.05.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/05/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
370
Accrual to date
Final
Recruitment outside Australia
Country [1] 5053 0
India
State/province [1] 5053 0
UTTAR PRADESH

Funding & Sponsors
Funding source category [1] 287191 0
Self funded/Unfunded
Name [1] 287191 0
BAPPADITYA MONDAL
Country [1] 287191 0
India
Primary sponsor type
Individual
Name
Dr Bappaditya Mondal
Address
Sanjay Gandhi Post Graduate Institute of Medical Sciences


MRA B1
RAE BARELI ROAD
LUCKNOW
UP
INDIA
226014
Country
India
Secondary sponsor category [1] 285954 0
None
Name [1] 285954 0
NIL
Address [1] 285954 0
NIL
Country [1] 285954 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 289185 0
The Institutional Ethics Committee (IEC) of SGPGIMS
Ethics committee address [1] 289185 0
RAE BARELI ROAD
LUCKNOW
UP
INDIA
226014
Ethics committee country [1] 289185 0
India
Date submitted for ethics approval [1] 289185 0
01/05/2013
Approval date [1] 289185 0
Ethics approval number [1] 289185 0

Summary
Brief summary
Pruritus is one of the most bothersome symptoms in patients on maintenance hemodialysis (HD), however little progress is seen in our understanding of its pathogenesis. The percentage of HD patients suffering from pruritus reportedly is higher than 50%. The aim of this study is to evaluate the frequency of pruritus in HD patients and to correlate its presence and intensity with relevant clinical and laboratory parameters.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 39654 0
Dr BAPPADITYA MONDAL
Address 39654 0
Sanjay Gandhi Post Graduate Institute of Medical Sciences

MRA B1
RAE BARELI ROAD
LUCKNOW
UP
INDIA
226014
Country 39654 0
India
Phone 39654 0
+917408536960
Fax 39654 0
Email 39654 0
[email protected]
Contact person for public queries
Name 39655 0
Dr BAPPADITYA MONDAL
Address 39655 0
Sanjay Gandhi Post Graduate Institute of Medical Sciences


MRA B1
RAE BARELI ROAD
LUCKNOW
UP
INDIA
226014
Country 39655 0
India
Phone 39655 0
+917408536960
Fax 39655 0
Email 39655 0
[email protected]
Contact person for scientific queries
Name 39656 0
Dr BAPPADITYA MONDAL
Address 39656 0
Sanjay Gandhi Post Graduate Institute of Medical Sciences

MRA B1
RAE BARELI ROAD
LUCKNOW
UP
INDIA
226014
Country 39656 0
India
Phone 39656 0
+917408536960
Fax 39656 0
Email 39656 0
[email protected]

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
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