| CTRI Number |
CTRI/2024/04/066080 [Registered on: 22/04/2024] Trial Registered Prospectively |
| Last Modified On: |
14/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Assessing Bladder wall thickness using ultrasound to predict catheter associated UTI in ICU patients |
|
Scientific Title of Study
|
Assessing the bladder wall thickness using Point Of Care Ultrasound (POCUS), and its correlation with colony forming units in urine culture samples of critically ill patients with suspected Catheter Associated Urinary Tract Infection (CAUTI) |
| 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 Gowtham Kumar A |
| Designation |
Junior resident, Anaesthesiology |
| Affiliation |
Institute Of Medical Sciences, BHU |
| Address |
Department of Anaesthesiology office, 1st floor, Sir Sunderlal Hospital, Banaras Hindu University, Pandit Madan Mohan Malviya Road, Kabir colony
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9597896729 |
| Fax |
|
| Email |
gowthamkumaranand@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Badri Prasad Das |
| Designation |
Associate Professor, Anaesthesiology |
| Affiliation |
Institute Of Medical Sciences, BHU |
| Address |
Department of Anaesthesiology office, 1st floor, Sir Sunderlal Hospital, Banaras Hindu University, Pandit Madan Mohan Malviya Road, Kabir colony
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9415214623 |
| Fax |
|
| Email |
badriprasad.dash5@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Badri Prasad Das |
| Designation |
Associate Professor, Anaesthesiology |
| Affiliation |
Institute Of Medical Sciences, BHU |
| Address |
Department of Anaesthesiology office, 1st floor, Sir Sunderlal Hospital, Banaras Hindu University, Pandit Madan Mohan Malviya Road, Kabir colony
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9415214623 |
| Fax |
|
| Email |
badriprasad.dash5@gmail.com |
|
|
Source of Monetary or Material Support
|
| Intensive Care Units, Department of Anaesthesiology, Institute of Medical Sciences, Banaras Hindu University, Varanasi |
|
|
Primary Sponsor
|
| Name |
Banaras Hindu University |
| Address |
Department of Anaesthesiology office, 1st floor, Sir Sunderlal Hospital, Banaras Hindu University, Pandit Madan Mohan Malviya Road, Kabir colony |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Gowtham Kumar A |
Institute Of Medical Sciences, BHU |
Intensive Care Unit, Department of Anaesthesiology , 1st floor, Sir Sunderlal Hospital, Banaras Hindu University, Pandit Madan Mohan Malviya Road, Kabir colony
Varanasi
UTTAR PRADESH |
09597896729
gowthamkumaranand@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Banaras Hindu University, Institute Of Medical Sciences_ethics _committee |
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 |
| Intervention |
Catheterisation as per protocol in ICU admitted patients |
Cohort (Study population) includes critically ill patients who required Foleys catheterisation With prior catheterisation of less than 4 days or requiring catheterisation within 4 days of ICU admission .
Baseline bladder wall thickness will be measured immediately after ICU admission and do observe bladder wall thickness every alternate day untill fever episode start after that bladder wall thickness will be measured every day
Regarding colony count baseline count will done after 72 hours of admission and on the day of fever episode and every 5th day. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Any critical illness requiring ICU admission for more than 5 days.
requiring catheterisation within 4 days of ICU admission . |
|
| ExclusionCriteria |
| Details |
1) Patients with prior catheterisation of more than 4 days
2) Previous urogenic operation such as bladder surgery, anti-reflex surgery.
3) Open wound in and around the suprapubic area.
4) Patient with known pyelonephritis, CKD having dialysis.
5) Known case of carcinoma bladder.
6) Known case of neurogenic bladder.
7) Pregnant women.
8) Women with fibroid, overactive bladder and pelvic organ prolapse.
9) Patient enrolled in other study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Correlation of BWT with CFU in urine culture samples of suspected
CAUTI patients .
|
Baseline bladder wall thickness will be measured immediately after ICU admission and do observe bladder wall thickness every alternate day untill fever episode start after that bladder wall thickness will be measured every day Untill Discharge/LAMA/Expire.
Regarding colony count baseline count will done after 72 hours of admission and on the day of fever episode and every 5th day Untill Discharge/LAMA/Expire.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Incidence of colonization & CAUTI.
Cut-off value of BWT for differentiating colonisation & CAUTI.
Effect of bladder wash with 2% Betadine (povidone iodine irrigation solution).
|
For effect of bladder wash, BWT will be taken on the day of fever & thereafter every day (after excluding other sources of infection) untill patient Discharge/LAMA/Expire. |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
30/04/2024 |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [badriprasad.dash5@gmail.com].
- For how long will this data be available start date provided 01-11-2026 and end date provided 01-11-2029?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Indwelling catheters are used routinely in the Intensive Care Units
(ICUs), usually for frequent and accurate monitoring of urinary output, which is indispensable for proper fluid balance in any critically ill
patient. Approximately 15-25% of hospitalized patients, and 98% of
ICU pts use a urinary catheter during their stay, and the majority of
these patients are catheterized for 2-7 days. But one of the integral problem to urinary catheterization is
urinary tract infection (UTI), which is the most common nosocomial
infection worldwide and accounts for almost 30–40% of all healthcare associated infections. Eighty percent of UTIs are attributable
to indwelling urinary catheter use. In severe cases, these infections may
lead to bacteremia, urosepsis, and even mortality. In addition to pain and discomfort, CAUTIs cause prolongation of
hospital stay by 1-4 extra days and increased use of antibiotics, with
consequent development of resistant microbial strains. Now, diagnosing CAUTI in a critically ill patient is a Hercules task, as
the patient, most of the times, is not capable of saying up the
symptoms (like suprapubic tenderness), and the diagnostic modalities
available to us takes time to diagnose CAUTI (Urine C/S, the accuracy of
which also depends on how well the sample of urine has been taken
out). As everyone knows, how time is crucial in diagnosing infection and
sepsis, and each minute delay in initiating antimicrobial therapy
increases mortality and morbidity by a great extent. Hence, timely and prompt diagnosis to CAUTI, though is challenging
for any intensivist, but is the need of the hour. Now, we all have a
portable USG machine in our ICU, accessible easily to us, which can be
used bedside in real time. USG has been used extensively by urologists
and radiologists, on OPD and mobile patients, to calculate post void
retained urine volume, detrusor muscle thickness and bladder wall
thickness in patients with overactive bladder and BPH, also in cystitis,
bladder stones, congenital deformities of bladder and tumors. But
bedside USG has never been used in critically ill patients for evaluation
of bladder wall thickness in screening and diagnosing CAUTI in ICU. In ultrasonography of urinary bladder to measure BWT we use 3.5MHz
curvilinear transducer. Transducer placed slightly above the symphysis
pubis and BWT measurement obtained from the anterior bladder wall
in both longitudinal and transverse planes. The bladder region will be
first delineated precisely. From this delineated bladder region the
bladder wall thickness will be calculated as the distance between the
outer and inner surfaces of the bladder. Multiple measurements of the
BWT for each participants will be taken and the average value for each
participants will be used. With this background, we have proceeded with an aim to access
serial ultrasonography in catheterized critically ill patients as a tool to
correlate urinary bladder wall thickness (BWT) and urinary tract
infection (CAUTI). |