| CTRI Number |
CTRI/2019/09/021306 [Registered on: 18/09/2019] Trial Registered Prospectively |
| Last Modified On: |
11/09/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical study to compare the incidence of Urinary Tract Infection between metal coated urinary catheter and conventional latex urinary catheter in ICU patients |
|
Scientific Title of Study
|
Incidence of bacterial and fungal Urinary Tract Infection with metal alloy impregnated urinary catheter (BIP foley catheter) in comparison to conventional latex foley catheter in ICU- a prospective interventional study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Badri Prasad Das |
| Designation |
Assistant professor |
| Affiliation |
IMS BHU |
| Address |
Department of anaesthesiology,
Institute of medical sciences
BHU
Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9415214623 |
| Fax |
|
| Email |
badriprasad.dash5@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Priya Singla |
| Designation |
Junior resident |
| Affiliation |
IMS BHU |
| Address |
Department of anaesthesiology
Institute of medical sciences
BHU
Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9999729484 |
| Fax |
|
| Email |
priyasingla.3192@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Munesh Kumar Gupta |
| Designation |
Assistant professor |
| Affiliation |
Institute of medical sciences BHU |
| Address |
Department of microbiology
Institute of medical sciences
BHU
Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8887649469 |
| Fax |
|
| Email |
guptamuneshkumar@gmail.com |
|
|
Source of Monetary or Material Support
|
| ICU, DEPT OF ANAESTHESIOLOGY, IMS BHU, VARANASI |
|
|
Primary Sponsor
|
| Name |
Dr BADRI PRASAD DAS |
| Address |
Assistant Professsor, Dept of Anaesthesiology, IMS BHU, Varanasi |
| Type of Sponsor |
Other [] |
|
|
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 |
| Priya singla |
Sir sunderlal hospital |
1st floorl, IMS BHU, Varanasi 221005
Varanasi
UTTAR PRADESH |
9999729484
Priyasingla.3192@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute of medical sciences ,Banaras Hindu University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N390||Urinary tract infection, site notspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional latex Foley catheter |
All adult patients fulfilling inclusion criteria with any critical illness, requiring urinary catheterisation for atleast 3 days, will be catheterised with the conventioanal catheter by the resident on duty. After insertion, the branding over the catheter will be obscured by a sterile brown tape. An independent resident will record the required observations. |
| Intervention |
Metal alloy impregnated urinary catheter (Silver, Gold and palladium alloy) (BIP Foley catheter) |
All adult patients fulfilling inclusion criteria with any critical illness, requiring urinary catheterisation for atleast 3 days, will be catheterised with the study catheter by the resident on duty. After insertion, the branding over the catheter will be obscured by a sterile brown tape. An independent resident will record the required observations. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients(>18 years and <60 years)
Admitted with any critical illness
No UTI
Requiring a urinary catheter for atleast 3 days
Using a closed drainage system
Will be included in the study |
|
| ExclusionCriteria |
| Details |
Children
Patients with UTI
Known case if BPH
Patients using open drainage system
Any congenital urinary tract abnormalities or obstetrics/gyanaecological abnormalities
Patients with duration of catheter< 3 days
Diabetic patients
Will be excluded from the study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of nosocomial urinary tract infection both bacterial and fungal including frequency of symptomatic catheter associated urinary tract infection and catheter associated asymptomatic bacteriuria |
after 3 days of onset of fever or earlier if fever occurs and at every onset of fever |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess safety and cost effectiveness clinical outcome in form of 30 days mortality |
Till 30 days or earlier when it needs to be removed due to blockage or patient dies or patient is shifted to ward |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="153" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/09/2019 |
| Date of Study Completion (India) |
30/08/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
All the adult patients between age group 18-60 years who were fulfilling the inclusion criteria were included in our study. Total patients recruited were 200 and these were randomised into group A(conventional foley catheter) and group B( BIP foley catheter) but due to covid pandemic we could not recruit the patients as targeted so total 153 patients were analysed. The primary end point,CAUTI was significantly less in group with metal alloy impregnated foley catheter(BIP foley catheter) as compared to conventional foley catheter(3.7 per 1000 catheter days vs 13.7 per 1000 catheter days with p value 0.006). As stated by secondary end point, less mortality was observed in griup with BIP foley catheter as compared to conventional foley catheter(25% vs 31.3%). This was clinically significant but not stastically significant. |