| CTRI Number |
CTRI/2025/09/095429 [Registered on: 26/09/2025] Trial Registered Prospectively |
| Last Modified On: |
26/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device Surgical/Anesthesia Process of Care Changes |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of use of isopropyl alcohol- impregnated central venous catheter caps |
|
Scientific Title of Study
|
Effect of use of isopropyl alcohol- impregnated central venous catheter caps on central line-associated bloodstream infections (CLABSI) |
| Trial Acronym |
CLABSI |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Arun Kuttil Varieth |
| Designation |
PG Resident |
| Affiliation |
Amrita Institute of Medical Sciences and Research Centre |
| Address |
6B Skyline Willow Heights
Gosaikunnu Kuriachira PO
Thrissur
Ernakulam KERALA 680006 India |
| Phone |
9447772910 |
| Fax |
|
| Email |
drarunvarier92@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Rajesh K |
| Designation |
Associate Professor |
| Affiliation |
Amrita Institute of Medical Sciences and Research Centre |
| Address |
Amrita School of Medicine
Ponekkara Road Edapally Kochi
Ernakulam KERALA 682041 India |
| Phone |
9847162134 |
| Fax |
|
| Email |
rajeshk@aims.amrita.edu |
|
Details of Contact Person Public Query
|
| Name |
Dr Zubair Umer Mohamed |
| Designation |
Associate Professor |
| Affiliation |
Amrita Institute of Medical Sciences and Research Centre |
| Address |
Amrita School of Medicine
Ponekkara Road Edapally Kochi
Ernakulam KERALA 682041 India |
| Phone |
9496038812 |
| Fax |
|
| Email |
zubairumer@gmail.com |
|
|
Source of Monetary or Material Support
|
| Amrita Institute of Medical Sciences and Research Centre |
|
|
Primary Sponsor
|
| Name |
Arun Kuttil Varieth |
| Address |
6B Skyline Willow Heights
Gosaikunnu Kuriachira PO
Thrissur 680006 |
| Type of Sponsor |
Other [SELF] |
|
|
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 ZUBAIR UMER MOHAMED |
Amrita Institute of Medical Sciences and Research Centre |
4/1 ICU/GICU
Department of Anaesthesiology and Critical Care,
Amrita Institute of Medical Sciences
and Research Centre, Kochi 682041 Ernakulam KERALA |
9496038812
zubairumer@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee of Amrita School of Medicine |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K928||Other specified diseases of the digestive system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Alcohol impregnated caps |
70% isopropyl alcohol impregnated central venous catheter caps. |
| Comparator Agent |
Standard caps |
Standard central venous catheter caps |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA Physical Status 1-3
(American Society of Anaesthesiologist) |
|
| ExclusionCriteria |
| Details |
Patients Without Central Line inserted |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the infection rates using isopropyl alcohol impregnated catheter caps vs standard central venous catheter caps. |
48 hours following insertion central venous catheter
to date of removal of central venous catheter |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| acceptability of the new intervention among the end users-nurses & doctors, average number of isopropyl impregnated caps required per central venous catheter, associated added cost per line |
1)48 hours following insertion central venous catheter.
2)1 week after central venous catheter insertion-if any.
3)date of removal of catheter
|
|
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
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)
|
15/10/2025 |
| 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 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
|
A central line-associated bloodstream infection (CLABSI) is a laboratory-confirmed bloodstream infection not related to an infection at another site that develops within 48 hours of central line placement. A central venous catheter is an indwelling device inserted into a large central vein most commonly the internal jugular, subclavian, or femoral and advanced until the terminal lumen resides within inferior vena cava, superior vena cava, or right atrium, it is a reliable and safe vascular access for care of patients in numerous clinical settings, ranging from infusion of parenteral nutrition and medication to hemodialysis. Despite their vital importance, these CVCs may cause potentially life-threatening complications, mostly central line-associated bloodstream infections (CLABSIs). Pathogens may enter the circulation via an extraluminal or the intraluminal route. Antiseptic barrier caps have been developed to decrease CLABSIs by reducing the effect of variations in scrubbing duration and techniques. These plastic caps contain a disinfectant, mostly 70% isopropyl alcohol.The cap is screwed directly onto the needle-less connector and continuously bathes the access point in an antimicrobial agent and can be left in place between infusions, providing improved disinfection and preventing touch or airborne pathogens from invading the hub. The order of selected pathogens associated with causing CLABSI are as follows. Gram-positive organisms. |