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临床试验/CTRI/2024/11/077013
CTRI/2024/11/077013尚未招募不适用

A Prospective Observational Study Of The Incidence and Risk Factors Of Catheter Associated Deep Vein Thrombosis in ICU Patients

Artemis Hospital1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2024年11月26日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
120
试验地点
1
主要终点
incidence and risk factors of central venous catheter associated deep vein thrombosis.

研究概览

简要总结

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.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • Patients with IJV or Femoral central venous catheter placement (Central venous line, dialysis catheter, introducer sheath).

排除标准

  • 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.

结局指标

主要结局

incidence and risk factors of central venous catheter associated deep vein thrombosis.

时间窗: incidence of thrombosis will be assessed at day 3,5,7,10 and 15

次要结局

  • 1.incidence of patient related risk factors.(2.incidence of catheter related risk factors.)

研究者

发起方
Artemis Hospital
申办方类型
Private hospital/clinic
责任方
Principal Investigator
主要研究者

Anjusha TV

Artemis hospital

研究点 (1)

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