| CTRI Number |
CTRI/2024/06/068298 [Registered on: 04/06/2024] Trial Registered Prospectively |
| Last Modified On: |
31/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Other |
|
Public Title of Study
|
Effectiveness of vitamin C and alkasol in change of urine pH to prevent UTI |
|
Scientific Title of Study
|
A Randomised controlled trial to assess the effectiveness of vitamin C and alkasol in change of urine pH to prevent UTI in perioperative females admitted in Neurosurgical ward at AIIMS ,New Delhi. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nandita |
| Designation |
M.Sc. Nursing |
| Affiliation |
All India Institute of Medical Sciences, AIIMS New Delhi |
| Address |
College of Nursing, AIIMS New Delhi
AIIMS, New Delhi
South West
DELHI
110029
India |
| Phone |
8851406778 |
| Fax |
|
| Email |
nsaharan487@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nandita |
| Designation |
Msc nursing |
| Affiliation |
All india institute of medical sciences,aiims new delhi |
| Address |
College of nursing,aiims new delhi
Aiims new delhi
South West
DELHI
110029
India |
| Phone |
8851406778 |
| Fax |
|
| Email |
nsaharan487@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aditi.P.Sinha |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences, AIIMS New Delhi |
| Address |
College of Nursing, AIIMS New Delhi
AIIMS New Delhi
South West
DELHI
110029
India |
| Phone |
9810784806 |
| Fax |
|
| Email |
aaditiprashant@gmail.com |
|
|
Source of Monetary or Material Support
|
| Neurosciences Center, AIIMS, New Delhi, 110028 |
|
|
Primary Sponsor
|
| Name |
Neurosurgery Ward |
| Address |
Neurosciences Center, AIIMS, New Delhi, 110028 |
| 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 |
| Ms Nandita |
All India Institute of Medical Sciences |
NS3 Ward, NS5 Ward, Neuro ICU, Department of Neurosurgery, Cardio-Neuro Centre(CNC) building,aiims new delhi
South West
DELHI |
8851406778
nsaharan487@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee for Post Graduate Research, AIIMS, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D337||Benign neoplasm of other specifiedparts of central nervous system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
change in urine ph by providing acidic/alkaline medium to prevent UTI |
Patient population that is perioperative females will be randomized into control and experimental group in which control will get the standard care provided at the hospital where as the experimental group patient will receive intervention of vitamin c (tab 500mg tds pre and postoperatively day 1) and syp alkasol (bd postoperatively) with total 4 days of intervention |
| Comparator Agent |
Standard care |
It refer to the cauti care provided at Neurosurgical unit
which include:
follow aseptic technique
position of the urobag should be lower than the bladder level
follow closed system
daily reviewand care
entry removal/entry sign of infection |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Female |
| Details |
Patients - females admitted in neurosurgery ward 1-2 days prior the operative day.
Willing to participate.
Able to understand Hindi or English.
Female patients with age above 18 years.
Patient with catheterization for minimum 48-72 hrs to maximum 7 days. |
|
| ExclusionCriteria |
| Details |
Patients - female with uti infection preoperatively based on Routine microscopy.
Having previous underlying medical condition including
uncontrolled diabetes mellitus
renal failure
chronic renal disease
stone management specific diet
symptomatic UTI requiring antibiotic therapy
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| change in urine ph help in prevention of uti in neurosurgery patient |
1 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| not applicable |
not applicable |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
01/08/2024 |
| 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="0"
Months="6"
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
|
Patient population that is perioperative females will be randamized into control and experimental group in which control will get the standard care provided at the hospital where as the experimental group patient will receive intervention of vitamin c (tab 500mg tds pre and postoperatively day 1) and syp alkasol (bd postoperatively da |