| CTRI Number |
CTRI/2017/09/009955 [Registered on: 28/09/2017] Trial Registered Retrospectively |
| Last Modified On: |
26/09/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
controlled trial for comparison of open versus closed catheter access system to prevention catheter related blood stream infections among critically ill patients admitted in intensive care units |
|
Scientific Title of Study
|
A randomized clinically controlled trial for comparison of open versus closed catheter access system in prevention of catheter related blood stream infections among critically ill patients admitted in intensive care units |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Davinder Kaur |
| Designation |
Principal |
| Affiliation |
Gian Sagar Medical College and Hospital, RamNagar, Rajpura |
| Address |
Gian Sagar College of Nursing, RamNagar, Rajpura
Gian Sagar Medical College and Hospital, RamNagar, Rajpura
Patiala
PUNJAB
140601
India |
| Phone |
09855045710 |
| Fax |
01762507757 |
| Email |
dav6aug@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sukhminder jit Singh Bajwa |
| Designation |
Professor |
| Affiliation |
Gian Sagar Medical College and Hospital, RamNagar, Rajpura |
| Address |
Dept of anesthesiology and Intensive care medicine
Gian Sagar Medical College and Hospital, RamNagar, Rajpura
Gian Sagar Medical College and Hospital, RamNagar, Rajpura
Patiala
PUNJAB
140601
India |
| Phone |
09915025828 |
| Fax |
|
| Email |
sukhminderbajwa@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Davinder Kaur |
| Designation |
Principal |
| Affiliation |
Gian Sagar Medical College and Hospital, RamNagar, Rajpura |
| Address |
Gian Sagar College of Nursing, RamNagar, Rajpura
Gian Sagar Medical College and Hospital, RamNagar, Rajpura
Patiala
PUNJAB
140601
India |
| Phone |
09855045710 |
| Fax |
01762-507757 |
| Email |
dav6aug@gmail.com |
|
|
Source of Monetary or Material Support
|
| Gian Sagar Medical College and Hospital RamNagar |
|
|
Primary Sponsor
|
| Name |
Gian Sagar Medical College and Hospital RamNagar |
| Address |
Gian Sagar Medical College and Hospital, RamNagar, Rajpura. Distt Patiala. Punjab |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Davinder kaur |
Gian Sagar Medical College and Hospital, RamNagar |
Gian Sagar Nursing College and ICU 2nd floor,Gian Sagar Medical college and Hospital, RamNagar
Patiala
PUNJAB |
09855045710
01762507757
dav6aug@gmail.com |
| Dr Sukhminderjit Singh Bajwa |
Gian Sagar Medical College and Hospital, RamNagar |
2nd floor, Intensive Care unit, Gian Sagar Medical College and Hospital, RamNagar
Patiala
PUNJAB |
9915025828
sukhminderbajwa@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Gian Sagar Medical College and Hospital, Department of Pharmacology, Village RamNagar,Tehsil Rajpura,Patiala140601,Punjab, India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients admitted in intensive care units who need central line catheters for one indication or other, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
3 way stopcock as open access system
Q-Syte by BD as closed access system |
3 way stopcock(control group) compared with Q-Syte( BD ) ( experimental group) with central venous catheters in prevention of CRBSI in critically ill patients |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
patients having central line at any site |
|
| ExclusionCriteria |
| Details |
patients will be excluded who already have infection i.e urine infection, surgical drain infection, chest infection
patients those who do not want to participate |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| prevention of catheter related blood stream infection among critically ill patients admitted in ICUs |
monitor the patient until CVC in situ |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| prevention of catheter related blood stream infection among critically ill patients admitted in ICUs which further improve septicemia and reduce hospital stay |
prevention of catheter related blood stream infection among critically ill patients admitted in ICUs which further improve septicemia and reduce hospital stay |
|
|
Target Sample Size
|
Total Sample Size="400"
Sample Size from India="400"
Final Enrollment numbers achieved (Total)= "400"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/01/2014 |
| Date of Study Completion (India) |
30/01/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
no publication done yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a randomized clinically controlled parallel group trial for comparison of open versus closed access system in prevention of catheter related blood stream infection among critically ill patients admitted in intensive care units at Gian Sagar medical college and Hospital, RamNagar. Rajpura, Distt. Patiala, Punjab.Total 400 patients(200 )in each group will be selected by sequentially numbered sealed opaque envelops. Efficacay of open versus closed catheter access system in prevention of catheter related blood stream infection will be evaluated |