| CTRI Number |
CTRI/2024/11/077013 [Registered on: 19/11/2024] Trial Registered Prospectively |
| Last Modified On: |
14/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
An observational study to find the incidence and risk factors of central venous catheter associated deep vein thrombosis in ICU patients |
|
Scientific Title of Study
|
A Prospective Observational Study Of The Incidence and Risk Factors Of Catheter Associated Deep Vein Thrombosis in ICU Patients
|
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anjusha TV |
| Designation |
critical care medicine resident |
| Affiliation |
Artemis hospital |
| Address |
Department of Critical Care Medicine
Artemis Hospital
Gurgaon HARYANA 122001 India |
| Phone |
8848225926 |
| Fax |
|
| Email |
anjushaashokan93@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Anjusha TV |
| Designation |
critical care medicine resident |
| Affiliation |
Artemis hospital |
| Address |
Department of Critical Care Medicine
Artemis Hospital
Gurgaon HARYANA 122001 India |
| Phone |
8848225926 |
| Fax |
|
| Email |
anjushaashokan93@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Anjusha TV |
| Designation |
critical care medicine resident |
| Affiliation |
Artemis hospital |
| Address |
Department of Critical Care Medicine
Artemis Hospital
Gurgaon HARYANA 122001 India |
| Phone |
8848225926 |
| Fax |
|
| Email |
anjushaashokan93@gmail.com |
|
|
Source of Monetary or Material Support
|
| Artemis hospital
sector 51, Gurgaon, Haryana
India 122001 |
|
|
Primary Sponsor
|
| Name |
Artemis Hospital |
| Address |
Artemis hospital
Sector 51
Gurugram, Haryana
India 122001 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Jeetendra Sharma |
ARTEMIS HOSPITAL |
Department of Critical care medicine
ICU-2
Gurgaon HARYANA |
7042118485
drjeetendrasharma@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Artemis health Sciences Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I824||Acute embolism and thrombosis of deep veins of lower extremity, (2) ICD-10 Condition: I82C||Embolism and thrombosis of internal jugular vein, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients with IJV or Femoral central venous catheter placement (Central venous line, dialysis catheter, introducer sheath) |
|
| ExclusionCriteria |
| Details |
1) Patient refusal to participate in the study
2) Patients who are less than 18 years old
3) Discharge / LAMA/ demise before 72 hours
4) Pre-existing haematological thrombotic disorder
5) Patients with active diagnosis of DVT/ pulmonary embolism
6) Any reason wherein USG examination not possible
7) Repeat catheter insertion in the same vein.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| incidence and risk factors of central venous catheter associated deep vein thrombosis. |
incidence of thrombosis will be assessed at day 3,5,7,10 and 15 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.incidence of patient related risk factors.
2.incidence of catheter related risk factors.
3. Occurrence of deep vein thrombosis with respect to time frame
4.incidence of deep vein thrombosis with respect to thromboprophylaxis.
5. Proportion of symptomatic & asymptomatic cases
|
1.incidence of patient & catheter related risk factors will be assessed after 28 days or till patient stay in hospital
3.Occurrence of deep vein thrombosis with respect to time frame on day 3,5,7,10,15 & 28
4.incidence of deep vein thrombosis with respect to thromboprophylaxis on day 3,5,7,10,15
5.Proportion of symptomatic & asymptomatic cases will be assessed till day 28 of hospital stay/discharge/demise
|
|
|
Target Sample Size
|
Total Sample Size="120" Sample Size from India="120"
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)
|
26/11/2024 |
| 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="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
|
Central venous catheters
are inserted in critically ill patients for various purposes. But they are also
associated with complications such as catheter associated deep vein thrombosis
which if kept undiagnosed or untreated, can lead to pulmonary embolism and increased
mortality. The following study hypothesise that there is significant incidence
of central line associated deep vein thrombosis in Intensive Care Unit (ICU)
patients. Routine screening for the same can help in early diagnosis of
thrombosis and prevent deterioration.
The primary objectives of
this study are to determine the incidence of catheter associated deep vein
thrombosis and to identify the risk factors associated with development of
thrombosis. Total of 120 patients with Internal Jugular Vein (IJV) or Femoral
venous line placement will be included in the study for evaluation. Catheters
removed within 72 hours, patient discharge / demise in 72 hours will be
excluded. Assessment for thrombosis will
be done using doppler ultrasound on IJV or femoral vein based on the site of
catheter inserted. Ultrasound assessment will be carried out on day 3,5,7,10
and 15 of catheter insertion and the observations will be tabulated irrespective
of catheter in situ or removed. If patient develops any symptoms, ultrasound
assessment will be done irrespective of the timeframe. Statistical analysis of
the data will be performed to determine the incidence, incidence rate, risk
factors related to patients and catheter. This study anticipates early
detection of asymptomatic thrombosis by routine ultrasound screening. Diagnosis
of thrombosis might help in treatment for the same and improved patient care. |