| CTRI Number |
CTRI/2022/08/044957 [Registered on: 26/08/2022] Trial Registered Prospectively |
| Last Modified On: |
06/08/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
“Incidence of peripheral venous thrombophlebitis in old age patients in critical care unit. |
|
Scientific Title of Study
|
“Incidence of peripheral venous thrombophlebitis in geriatric patients in critical care unit: A prospective observational study†|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sujit Kshirsagar |
| Designation |
Assistant Professor |
| Affiliation |
B.J. Medical College and sassoon general hospitals, Pune |
| Address |
Jai Prakash Narayan Road, Railway Station Rd, near Pune Railway Station, Maharashtra- 411001
Pune MAHARASHTRA 411001 India |
| Phone |
09022177719 |
| Fax |
|
| Email |
bjsujit@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sujit Kshirsagar |
| Designation |
Assistant Professor |
| Affiliation |
B.J. Medical College and sassoon general hospitals, Pune |
| Address |
Jai Prakash Narayan Road, Railway Station Rd, near Pune Railway Station, Maharashtra- 411001
Pune MAHARASHTRA 411001 India |
| Phone |
09022177719 |
| Fax |
|
| Email |
bjsujit@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Sujit Kshirsagar |
| Designation |
Assistant Professor |
| Affiliation |
B.J. Medical College and sassoon general hospitals, Pune |
| Address |
Jai Prakash Narayan Road, Railway Station Rd, near Pune Railway Station, Maharashtra- 411001
Pune MAHARASHTRA 411001 India |
| Phone |
09022177719 |
| Fax |
|
| Email |
bjsujit@gmail.com |
|
|
Source of Monetary or Material Support
|
| B.J. Govt. Medical College and SGH, Pune |
|
|
Primary Sponsor
|
| Name |
Dr Sujit Kshirsagar |
| Address |
Jai Prakash Narayan Road, Railway Station Rd, near Pune Railway Station, Maharashtra- 411001 |
| 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 Sujit J Kshirsagar |
Trauma ICU, Trauma care center, B. J. Govt. MEDICAL COLLEGE and SASSOON GENERAL HOSPITALS, PUNE |
Jai Prakash Narayan Road, Railway Station Rd, near Pune Railway Station, Maharashtra- 411001 Pune MAHARASHTRA |
09022177719
bjsujit@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, B. J. Govt. MEDICAL COLLEGE, SASSOON GENERAL HOSPITALS, PUNE |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: T888||Other specified complications of surgical and medical care, not elsewhere classified, |
|
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Intervention / Comparator Agent
|
|
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Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
95.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with age more than 60 yrs.
2. Patients admitted in critical care unit
3. Patients of either gender
|
|
| ExclusionCriteria |
| Details |
1. Patients with age less than 60 yrs. |
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
to evaluate the incidence of peripheral venous thrombophlebitis in
geriatric patients.
|
0 hrs, 12 hrs, 24 hrs, 36 hrs, 48 hrs, 60 hrs, 72 hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to study the risk factors associated with thrombophlebitis. |
0 hrs, 12 hrs, 24 hrs, 36 hrs, 48 hrs, 60 hrs, 72 hrs |
|
|
Target Sample Size
|
Total Sample Size="70" Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
31/08/2022 |
| Date of Study Completion (India) |
01/01/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0" Months="3" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
1. Tolpadi A, Mane A, Modak M, Verma AK, Ambekar V, Shilawat T. Impact of interventions on the incidence of thrombophlebitis in peripheral venous cannulation in a tertiary care teaching hospital. Int Surg J 2021;8:2007-11
2. Park HJ, Kim KH, Lee HJ, Jeong EC, Kim KW, Suh DI. Compartment syndrome due to extravasation of peripheral parenteral nutrition: extravasation injury of parenteral nutrition. Korean J Pediatr. 2015;58:454–8.
3. Sacks GS, Mir TL, Lee M. Skin necrosis induced by extravasation of glycerol-containing peripheral parenteral nutrition formulation. J Miss State Med Assoc. 1999;40:307–11.
4. Kahn JM, Kress JP, Hall JB. Skin necrosis after extravasation of low-dose vasopressin administered for septic shock. Crit Care Med. 2002;30:1899–01
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Peripheral venous catheters (PVC) are most
commonly used invasive devices in critical care unit. Insertion of PVC causes
local inflammation of veins and thrombus formation i.e. thrombophlebitis. It
may lead to other complications like pain, anxiety, and therapy interruption
and can potentially lead to serious complications (e.g pulmonary embolism, deep
vein thrombosis, septicemia, formation of nodule and cellulitis, skin necrosis,
infective endocarditis).[1-4] The incidence of thrombophlebitis
phlebitis is around 7–44% in PVC. [5-8] Geriatric patients often
present with vein stiffness, either as a result of clinical conditions such as
atherosclerosis or other conditions brought on by aging. Furthermore, they
often present a pathology requiring the use of anticoagulants. In these cases, it may be hard to place a peripheral
venous catheter due to the fragility of vein walls, and may be damaged
more easily. Furthermore, the risk of phlebitis is significantly higher in
these patients. It must be remembered that elderly patients are more likely to suffer infections due to
the natural deterioration of their immune system. Increasing hygiene and
disinfection measures and looking out for any symptoms of thrombophlebitis is
crucial in these cases.
So, we decided to study incidence of PVC
induced thrombophlebitis in geriatric patients in critical care unit. |