| CTRI Number |
CTRI/2024/09/073468 [Registered on: 05/09/2024] Trial Registered Prospectively |
| Last Modified On: |
31/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Role of metal alloy impregnated foleys catheter in preventing urine tract infection in critically ill patients. |
|
Scientific Title of Study
|
Role of metal alloy impregnated foleys catheter in catheter associated urinary tract infection in ICU patients:A prospective randomised comparative study. |
| Trial Acronym |
Catheter associated urinary tract infection prevention |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Naman Gupta |
| Designation |
Junior resident |
| Affiliation |
King george medical University |
| Address |
Department of anaesthesiology, king george medical University, lucknow.
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
8445747418 |
| Fax |
|
| Email |
namanguptabah@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Brij Bihari kushwaha |
| Designation |
Professor |
| Affiliation |
King george medical University |
| Address |
Department of anaesthesiology, king george medical University, lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9336900634 |
| Fax |
|
| Email |
brij_kushwaha00634@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Brij Bihari kushwaha |
| Designation |
Professor |
| Affiliation |
King george medical University |
| Address |
Department of anaesthesiology, king george medical University, lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9336900634 |
| Fax |
|
| Email |
brij_kushwaha00634@yahoo.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
King George Medical University |
| Address |
Chowk, Lucknow, 226003 |
| Type of Sponsor |
Government 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 |
| Naman Gupta |
King George Medical University |
Department of Anaesthesiology and Critical Care, Near Gate no 2, CHOWK,LUCKNOW 226003
Lucknow
UTTAR PRADESH |
8445747418
namanguptabah@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,KING GEORGE MEDICAL UNIVERSITY,Lucknow |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional latex Foleys catheterization |
ICU admitted patients of either sex, age between 20-60 years will be screened for any suspected already existing urinary tract infectious. After admission urine sample will be send for routine microscopy & will see pus-cell. If sample puscell 5/hpf, the patients will be enrolled for study.
patients will be Catheterized by latex foley’s catheter. We will repeat of sample after 7 day and 14 days for urine routine microscopy & culture. We will see microbial infection (bacterial, fungal or any parasitic infection). We will look for any allergy,reaction & complication |
| Intervention |
latex foley’s with metal alloy catheterization |
ICU admitted patients of either sex, age between 20-60 years will be screened for any suspected already existing urinary tract infectious. After admission urine sample will be send for routine microscopy & will see pus-cell. If sample puscell 5/hpf, the patients will be enrolled for study.
In this intervention, patients will be catherized by latex foley’s with metal alloy impregnant.
• We will repeat of sample after 7 day and 14 days for urine routine microscopy & culture. We will see microbial infection (bacterial, fungal or any parasitic infection). We will look for any allergy,reaction & complication with these catherize patients with latex & alloy cather. All collected data will be used for statistical analysis |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ICU admitted patient.
Absence of urinary tract infection.
No sign of urinary tract infection. |
|
| ExclusionCriteria |
| Details |
• H/O known Latex allergy/metal alloy
• Prior Urinary tract surgery
• Pregnancy or breast-feeding patients
• Taking any prophylactic antibiotic for prevention of urinary tract infection
• First culture positive for microbial infection
• Symptoms S/O urinary tract infection present.
• Contraindication of foleys catheterization
• Bleeding disorder |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare incidence rate of CAUTI in metal alloy coated catheter with non-metal allot catheter group. |
At the first day of foleys, 7th day and 14th day of foleys insertion sample to be send |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare both group for Latex catheter/alloy related complication. |
14 days |
|
|
Target Sample Size
|
Total Sample Size="82"
Sample Size from India="82"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
30/09/2024 |
| 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
|
The study will be conducted on admitted patients in CCU unit of department of Anaesthesia KGMU. A written and informed consent will be taken from either of parents or relative of the patients who were admitted in the ICU fulfilling inclusion-exclusion criteria & enrolled for study. For enrollment, all ICU admitted patients of either sex, age between 20-60 years will be screened for any suspected already existing urinary tract infectious. After admission urine sample will be send for routine microscopy & will see pus-cell. If sample puscell <5/hpf, the patients will be enrolled for study. All enrolled patients will be randomly allocated into either of two group-A & group- B. In group-A patients will be Catheterized by latex foley’s catheter. In group-B patients will be catherized by latex foley’s with metal alloy impregnant. We will repeat of sample after 7 day and 14 days for urine routine microscopy & culture. We will see microbial infection (bacterial, fungal or any parasitic infection). We will look for any allergy,reaction & complication with these catherize patients with latex & alloy cather. All collected data will be used for statistical analysis |