INTRACATHETER NITROGLYCERIN INFUSION IN PREVENTION OF FEMORAL VENOUS THROMBOSIS

导管内输注硝酸甘油预防股静脉血栓形成

• 批准号: 6122858
• 负责人: BRIAN KRAFTE-JACOBS
• 金额: $ 0.39万
• 依托单位: CINCINNATI CHILDRENS HOSP MED CTR
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-12-01 至 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6122858
• 关键词: cardiovascular disorder prevention; catheterization; chemoprevention; child (0-11); clinical research; critical care; human subject; human therapy evaluation; intravenous administration; nitroglycerin; outcomes research; ultrasonography; venous thrombosis

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.

本研究的目的是通过超声检查来研究危重患儿经皮放置股静脉导管后，导管内输注硝酸甘油对血管血栓形成发生率的影响。 我们假设，与对照导管相比，导管内硝酸甘油输注与血栓形成的发生率较低相关。 该研究将包括总共62名儿童，年龄从出生到6岁。 将研究两组。 第1组（硝酸甘油组; n=31）将包括入住重症监护室的危重患儿，初级护理团队已选择在这些患儿中放置双腔或三腔股静脉导管。第2组（D5 W; n=31）还将包括入住重症监护室的重症儿童，初级保健团队选择在这些儿童中放置双腔或三腔股静脉导管。 由放射学研究者在导管插入后2天内对插入导管的股静脉进行超声检查和分析，并在出院前进行最终研究。 主要结果变量是硝酸甘油组和D5 W组之间超声诊断血栓形成发生率的差异。 次要结局变量包括两组之间血栓形成临床证据的差异、两组之间导管相关感染发生率的差异、TPN、胰岛素和肝素输注对各组血栓形成的影响以及导管持续时间对各组血栓形成的影响。到目前为止，62名所需参与者中已有40人参加。 入组一直是一个限制因素，但如果我们能达到平均每月2人的入组人数，这项研究可以在12个月内完成。 入学人数可以增加与研究员更积极的教育和研究协调员的可用性增加。 目前尚无中期业绩。