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CTRI Number  CTRI/2025/11/097756 [Registered on: 20/11/2025] Trial Registered Prospectively
Last Modified On: 20/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   A Study to Develop a Checklist for Safer Vascular Access Care in Hemodialysis Patients. 
Scientific Title of Study   Development and Validation of Checklist for Hemodialysis Vascular Access Care in Individuals Diagnosed with End Stage Kidney Disease 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  Karthik S Kammar 
Designation  Post Graduate Student 
Affiliation  Manipal College of Health Profession,MAHE 
Address  Department of Renal replacement Therapy and Dialysis Technology Manipal College of Health Profession,MAHE,Manipal,Udupi,Karnataka,576104,India

Udupi
KARNATAKA
576104
India 
Phone  9538432979  
Fax    
Email  karthik.mchpmpl2024@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Ravindra Prabhu A 
Designation  Professor 
Affiliation  Department of Nephrology Kasturba Hospital Manipal 
Address  Department of Nephrology, Kasturba Hospital MAHE,Manipal,Karnataka,India 576104

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  Manipal College of Health Profession,MAHE 
Address  Department of Renal replacement Therapy and Dialysis technology MCHP,MAHE,Manipal,Udupi,Karnataka,India,576104

Udupi
KARNATAKA
576104
India 
Phone  9482498153  
Fax    
Email  megha.nayak@manipal.edu  
 
Source of Monetary or Material Support  
Manipal Academy of Higher Education Manipal,Udupi,Karnataka,576104,India 
 
Primary Sponsor  
Name  Karthik S Kammar 
Address  Department of Renal Replacement Therapy and Dialysis Technology,MCHP,MAHE,Manipal,Udupi,Karnataka,576104,India 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  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  Manipal Academy of Higher education  Department of Renal Replacement Therapy and Dialysis technology, Kasturba Hospital,Manipal,Udupi,Karnataka,576104
Udupi
KARNATAKA 		 9448107771

ravindra.prabhu@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Experienced Hemodialysis Healthcare Workers 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Both 
Details  Experienced Health Care Workers  
 
ExclusionCriteria 
Details  Patients on dialysis aged above 18 years for a long term with no specific signs of infections or complications.
Hemodynamically unstable patients.
Patients with well-developed AV fistula Access.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Validated checklist for infection control practices.
Incidence of VA infection.
Challenges/ barriers to follow.
Decreased complication and infection rate by following the Validated checklist before initiation of dialysis.
 		 Checklist Development within 4 months, Validation of the Checklist within 3 months, Face validity of the Hemodialysis Healthcare workers 3 months  
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="12"
Sample Size from India="12" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   16/12/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="10"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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  
End-stage kidney disease [ESKD] patients undergoing maintenance hemodialysis are at high risk of vascular access-related infections, Largely due to inconsistent infection control practices during cannulation, dialysis and decannulation. Currently, there is no standardized and validated checklist specifically designed for infection control practices related to hemodialysis vascular access care in India.
This study aims to develop and validate an evidence-based infection control practices checklist for vascular access care. using the Delphi technique, experts in nephrology, dialysis technology, and infection control will help to create and refine the checklist. The study will also observe current infection control practices among healthcare workers and assess the incidence of vascular access infections and common challenges faced during routine dialysis care. The validated checklist is expected to improve adherence to infection control practices, reduce infection rates, and enhance patient safety and quality of care during hemodialysis. 
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