CTRI

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CTRI Number

CTRI/2025/11/097456 [Registered on: 14/11/2025] Trial Registered Prospectively

Last Modified On:

06/06/2026

Post Graduate Thesis

Yes

Type of Trial

Observational

Type of Study

Cross Sectional Study

Study Design

Other

Public Title of Study

Development and testing of a simple questionnaire to check how much people on regular dialysis know about fluid removal (ultrafiltration) and its possible problems.

Scientific Title of Study

Development and validation of a questionnaire to assess the awareness regarding the ultrafiltration and related complications in individuals undergoing maintenance hemodialysis.

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Akhilesh Hipparagi
Designation	Student pursuing M.Sc. RRT&DT
Affiliation	MCHP MAHE Manipal
Address	Department of RRT and DT MCHP MAHE Manipal Udupi KARNATAKA 576104 India
Phone	6361986829
Fax
Email	akhilesh.mchpmpl2024@learner.manipal.edu

Details of Contact Person
Scientific Query

Name	Dr Ravindra Prabhu A
Designation	Professor
Affiliation	KMC MAHE Manipal
Address	Department of Nephrology KMC MAHE Manipal Udupi KARNATAKA 576104 India
Phone	9448107771
Fax
Email	ravindra.prabhu@manipal.edu

Details of Contact Person
Public Query

Name	Megha Nagaraj Nayak
Designation	Assistant Professor-selection Grade
Affiliation	MCHP MAHE Manipal
Address	Department of RRT and DT MCHP MAHE Manipal Udupi KARNATAKA 576104 India
Phone	9482498153
Fax
Email	megha.nayak@manipal.edu

Source of Monetary or Material Support

Manipal Academy of Higher Education, Karnataka, Udupi, Manipal-576104, India.

Primary Sponsor

Name	Akhilesh Hipparagi
Address	Department of RRT and DT, MCHP, MAHE, Karnataka, Udupi, Manipal-576104, India.
Type of Sponsor	Other [self]

Details of Secondary Sponsor

Name	Address
NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Ravindra Prabhu A	Kasturba Medical College	Department of Nephrology, KMC, MAHE, Karnataka, Udupi, Manipal-576104, India. Udupi KARNATAKA	9448107771 ravindra.prabhu@manipal.edu

Details of Ethics Committee
Modification(s)

No of Ethics Committees= 2
Name of Committee	Approval Status
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee - 2	Approved
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee 2	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: N186\|\|End stage renal disease,

Intervention / Comparator Agent

Type	Name	Details
Intervention	Nil	Nil

Inclusion Criteria

Age From	18.00 Year(s)
Age To	85.00 Year(s)
Gender	Both
Details	5 members in the questionnaire development team. professionals with expertise related to the contents of the questionnaire. Experts will be from the following fields. Nephrologist or general physician and dialysis technology field expert or educator or academician. Expert in health data and information standards. On a need basis. One representative from patients or a caregiver will be recruited for this team. 5 members will be in the questionnaire validation team. This team will include experts from nephrology and dialysis technology and general medicine and statistics. Minimum five years of experience and willing to give informed consent. There will be no overlapping of members between the two teams.12 patients who have been undergoing maintenance hemodialysis for at least one year will be included. They must be able to read and understand english.

ExclusionCriteria

Details

Medical students or interns. Patients with psychiatric illness. A person is unable to read and write english.

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
A content validated reliable and user friendly questionnaire in English.	Questionnaire development within 4 months. Validation of the questionnaire within 3 months. Face validity of the patients for 3 months.

Secondary Outcome

Outcome	TimePoints
NIL	NIL

Target Sample Size

Total Sample Size="22"
Sample Size from India="22"
Final Enrollment numbers achieved (Total)= "140"
Final Enrollment numbers achieved (India)="140"

Phase of Trial

N/A

Date of First Enrollment (India)

25/11/2025

Date of Study Completion (India)

05/06/2026

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Date Missing

Estimated Duration of Trial

Years="0"
Months="10"
Days="0"

Recruitment Status of Trial (Global)

Not Yet Recruiting

Recruitment Status of Trial (India)

Completed

Publication Details

N/A

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - NO

Brief Summary

Patients with kidney failure who are on regular hemodialysis need to remove extra fluid from their bodies through a process called ultrafiltration. If this process is not properly managed, it can lead to health problems such as low blood pressure and cramp complications. Many patients may not have enough knowledge about how ultrafiltration works or how to prevent its complications.

This study aims to develop and validate a questionnaire that measures patient knowledge of ultrafiltration and its related issues. The questionnaire will first be developed and validated by collecting information from experts through semi structured interviews. Then it will be tested among patients on maintenance hemodialysis to ensure it is clear and accurate.

The results of this study will help healthcare professionals understand the level of awareness among dialysis patients and plan better education programs to improve patient safety and quality of life.