INTRACATHETER NITROGLYCERIN INFUSION IN PREVENTION OF FEMORAL VENOUS THROMBOSIS

本研究旨在探讨经皮置股静脉导管对危重儿童导管内输注硝酸甘油对血管血栓发生率的影响。我们假设，与对照导管相比，导管内硝酸甘油输注将与较低的血栓发生率相关。这项研究将包括62名从出生到6岁的儿童。我们将研究两组人。第1组（硝酸甘油，n=31）将包括重症监护病房收治的危重儿童，初级保健小组选择放置双腔或三腔股静脉导管。第2组（5w, n=31）还包括重症监护室收治的危重患儿，其中初级保健团队选择放置双腔或三腔股静脉导管。导管插入后2天内，放射科调查员将对置入的股静脉进行超声检查和分析，出院前进行最后的检查。主要结局变量是超声诊断血栓形成的发生率在硝酸甘油组和D5W组之间的差异。次要结局变量包括两组血栓形成的临床证据差异、两组导管相关感染发生率差异、TPN、脂质内、肝素输注对两组血栓形成的影响、置管时间对两组血栓形成的影响。迄今为止，所需的62名参与者中已有40人报名参加。入组人数一直是一个限制因素，但如果我们能使入组人数达到平均每月2人，研究可以在12个月内完成。通过对研究员进行更积极的教育和增加研究协调员的可用性，可以增加注册人数。目前还没有中期结果。

The purpose of this study is to investigate by sonography the impact of intracatheter nitroglycerin infusion upon the incidence of vascular thrombosis following percutaneous placement of femoral venous catheters in critically ill children. We hypothesize that intracatheter nitroglycerin infusion will be associated with a lower incidence of thrombosis when compared to control catheters. The study will include a total of 62 children ages birth to 6 years of age. Two groups will be studied. Group 1 (nitroglycerin; n=31) will include critically ill children admitted to the intensive care unit in whom the primary care team has elected to place a double or triple lumen femoral venous catheter. Group 2 (D5W; n=31) will also include critically ill children admitted to the intensive care unit in whom the primary care team has elected to place a double or triple lumen femoral venous catheter. Ultrasound examinations of the catheterized femoral vein will be performed and analyzed by the Radiology investigator within 2 days of catheter insertion and a final study will be performed prior to discharge from the hospital. The primary outcome variable is the difference in the incidence of ultrasound-diagnosed thrombosis between the nitroglycerin and D5W groups. Secondary outcome variables include difference in clinical evidence of thrombosis between the two groups, difference in the incidence of catheter-related infection between the two groups, impact of TPN, intralipid, and heparin infusions on thrombosis in each group, and impact of catheter duration on thrombosis in each group. To date, 40 of the 62 needed participants have been enrolled. Enrollment has been a limiting factor, but if we can get enrollment up to an average of 2 per month, the study could be completed in 12 months. Enrollment can be increased with more aggressive education of the fellows and increased availability of the study coordinator. No interim results are available at this time.