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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  
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 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 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: T888||Other specified complications of surgical and medical care, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
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. 
 
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  
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.

 
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