remic pruritus: a clinical observational study of maintenance hemodialysis patients.

Not Applicable

• Conditions: Pruritus in Hemodialysis Patient.; Renal and Urogenital - Kidney disease

• Registration Number: ACTRN12613000507785
• Lead Sponsor: Dr Bappaditya Mondal

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-05-08
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 370

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

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

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The frequency of pruritus in hemodialysis patients and relationship with different clinical and laboratory parameters.<br> <br> 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.[- It's a cross sectional observational study.<br>- Including pstient who are on hemodialysis for more than 3 months. ]

Secondary Outcome Measures

Name	Time	Method
IL[NIL]