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临床试验/NCT06573112
NCT06573112已完成不适用

Incidence, Factors Associated and Outcomes of Central Venous Catheter-Related Thrombosis in Critically Ill Patients, a Prospective Cohort Study

Sultan Qaboos University1 个研究点 分布在 1 个国家目标入组 315 人开始时间: 2024年7月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
315
试验地点
1
主要终点
Incidence of Catheter-related thrombosis (CRT)

研究概览

简要总结

This project aims to identify catheter-related thrombosis (CRT) and determine its incidence, associated factors, and outcomes. The eligible patients will undergo daily ultrasound just distal to the central venous catheter insertion site for CRT. A staff radiologist will review all positive cases. These cases will be monitored by daily ultrasound examination till three days after the removal of the catheter or till the patient stays in the intensive care unit (ICU). The patient demographics, ICU treatment details, and outcomes will be noted. The data will be then analyzed. A preventive strategy will be prepared and disseminated to the department personnel to improve the quality of care.

详细描述

Central venous catheter (CVC) insertion is a common procedure for critically ill patients. The CVCs are inserted on any site, including the internal jugular, subclavian, brachio-cephalic, and femoral veins. The endothelium of the vein is injured with CVC placements, and this predisposes to the formation of thrombus in addition to other predisposing factors like immobility, thrombophilia, reduced venous blood flow, hypercoagulable state, catheter material, catheter diameter to vein diameter ratio, CVC tip position, etc. The catheter fills up the lumen space intravenously, thereby reducing blood flow inside the vein. This slow flow state can predispose to thrombus formation.

Peripherally inserted central catheters might have a higher incidence of CRT due to this reason. CRT forms mostly at the insertion site, frequently within the first week of catheterization. The clinical manifestation of CRT can vary according to the size and site of the thrombus. It is frequently asymptomatic; however, most patients develop signs and symptoms like edema, pain, erythema, weakness, and sometimes superficial venous circles (Urschel's sign). If the vein involved with CRT is the superior vena cava of the anonymous vein, there could be signs of superior vena cava (SVC) syndrome. CRT is frequently evident with inadequate catheter flow. As a consequence of CVC thrombus development at different sites and severity, complications like deep vein thrombosis (DVT) extension, compartment syndrome, SVC syndrome, catheter infection, and permanent venous obstruction can develop. Sometimes, there can be the end-organ effect of the thrombus migration, causing a pulmonary embolism (PE), ischemic stroke, and embolism to the gut, liver, kidneys, and heart. These can significantly impact the patient outcome, such as the length of stay in the ICU.

Aim of the Study: This research aims to study the incidence and associated factors, including the initial catheter-to-vein diameter ratio, and the outcomes of CRT at a tertiary-level university hospital in Oman. With these data, we will understand the condition and form a preventive strategy for CRT for critically ill patients.

Methods: This prospective study will include enrollment, daily observation, and follow-up of all patients undergoing a new CVC placement in the ICU. After obtaining ethical approval, the study will be registered at one of the registries (Clinicaltrials platform). All patients admitted to the ICU would be approached, and those getting CVC placement would be given information about this research with the help of an information sheet. All patients/or their relatives who consent to participate will be included during the study period. Ultrasound assessment will be done on admission and every day till discharge from ICU or up to three days after CVC removal if in ICU.

Ultrasound assessment: This will involve examination of the central vein at and distal to the catheter site. The examination will detect echogenic mass and compressibility in the vein, as well as evaluate the color flow. A diagnosis of CRT will be made if there is an echogenic mass and either incompressibility or absent color flow. A radiologist will review all the positive cases. Partial occlusion will be defined by partially occluding intraluminal echogenic filling defect, and complete occlusion will be defined as intraluminal occluding thrombus with rounding and non-compressibility of vein and absence of color flow on Doppler. In addition to the diagnosis, the dimensions of the thrombus will be measured every day. The outer diameter of the catheter and the catheter-vein diameter (CVD) ratio will be calculated on the day of CVC insertion. The extraluminal hematoma will also be measured.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients (>18 years of age) undergoing Central Venous Catheter (CVC) placements in the ICU or emergency department while waiting for admission to the ICU.

排除标准

  • Pre-existing deep vein thrombosis (DVT),
  • Pre-existing CVC at ICU admission (other than placement in the emergency department)
  • Refusal to consent.

结局指标

主要结局

Incidence of Catheter-related thrombosis (CRT)

时间窗: one year approximately

Incidence of CRT in critically ill patients

次要结局

  • Length of stay in ICU(one year approximately)
  • Rate of cases developing ischemic complications(one year approximately)
  • Mortality at 28 and 90 days(one year approximately)
  • Presence of factors associated with the development of CRT(one year approximately)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Jyoti Burad

Senior Specialist

Sultan Qaboos University

研究点 (1)

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