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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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