| CTRI Number |
CTRI/2025/08/092603 [Registered on: 07/08/2025] Trial Registered Prospectively |
| Last Modified On: |
07/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Checking infection control practices in dialysis unit using an audit. |
|
Scientific Title of Study
|
Assessment of Infection Control Practices in a Hemodialysis unit using CDC Guidelines: a closed-Loop Audit |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shahin Vishani |
| Designation |
Assistant Professor |
| Affiliation |
Datta Mege Institute of Higher Education and Research |
| Address |
Department of Microbiology, 2 floor, JNMC building, Sawngi, Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
9156045259 |
| Fax |
|
| Email |
shahinsv20@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gargi Mudey |
| Designation |
Professor and Head of Department |
| Affiliation |
Datta Mege Institute of Higher Education and Research |
| Address |
Department of Microbiology, 2 floor, JNMC building, Sawngi, Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
9860265849 |
| Fax |
|
| Email |
gargimudey@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gargi Mudey |
| Designation |
Professor and Head of Department |
| Affiliation |
Datta Mege Institute of Higher Education and Research |
| Address |
Department of Microbiology, 2 floor, JNMC building, Sawngi, Meghe
MAHARASHTRA
442001
India |
| Phone |
9860265849 |
| Fax |
|
| Email |
gargimudey@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Mege Institute of Higher Education and Research, Sawangi, Mehe, Wardha, Maharashtra, India. 442001 |
|
|
Primary Sponsor
|
| Name |
Datta Mege Institute of Higher Education and Research |
| Address |
Sawangi, Mehe, Wardha, Maharashtra, India. 442001 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shahin Vishani |
Jawaharlal Nehru Medical College |
Department of Microbiology, 2 floor, JNMC building, Sawngi, Meghe
Wardha
MAHARASHTRA |
09156045259
shahinsv20@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Datta Mege Institute of Higher Education and Research, Wardha, |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Assessment of Infection Control Practices of health care workers in a Hemodialysis Unit using CDC Guidelines |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
teaching learning sessions for health care workers |
sessions will be provided to health care workers on infection control practices at dialysis unit for 1 week |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Health care workers
2. Patients of haemodialysis unit
|
|
| ExclusionCriteria |
| Details |
1. Any other type of dialysis cases
2. Not consenting for study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improved compliance with CDC guidelines and reduction in infection rates. |
Assessment will be done at baseline, at 8 weeks, and 16 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
15/09/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Infection control in hemodialysis units is
critical due to the high vulnerability of patients to bloodstream infections
and other healthcare-associated infections (HAIs).The Centers for
Disease Control and Prevention (CDC) has developed evidence-based guidelines
and checklists to standardize and improve infection prevention practices in
these settings. Despite the availability of these resources, adherence to
infection control measures varies potentially leading to increased morbidity,
mortality, and healthcare costs. Infection control in hemodialysis units is
critical due to the high vulnerability of patients to bloodstream infections
and other healthcare-associated infections (HAIs). The Centers for
Disease Control and Prevention (CDC) has developed evidence-based guidelines
and checklists to standardize and improve infection prevention practices in
these settings. Despite the availability of these resources, adherence to
infection control measures varies potentially leading to increased morbidity,
mortality, and healthcare costs. This study aims to assess and improve infection control practices
in a hemodialysis unit using CDC guidelines and checklist tools through a
closed-loop audit. This will be a interventional study conducted at Jawaharlal Nehru Medical College India. |