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: 6414967
• 负责人: BRIAN KRAFTE-JACOBS
• 金额: $ 2.85万
• 依托单位: CINCINNATI CHILDRENS HOSP MED CTR
• 依托单位国家: 美国
• 财政年份: 2000
• 资助国家: 美国
• 起止时间: 2000-12-01 至 2001-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6414967
• 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.

这项研究的目的是通过超声检查调查体内硝酸甘油输注对股骨静脉导管在重症儿童中经皮静脉静脉导管后血管血栓形成的发生的影响。 我们假设与对照导管相比，在体内硝酸甘油输注与血栓形成的发生率较低有关。 这项研究将包括62名年龄在6岁的儿童。 将研究两组。 第1组（硝酸甘油; n = 31）将包括重症监护病房的重症儿童，初级保健团队选择了双层或三重流明股静脉导管。第2组（D5W; n = 31）还将包括接受重症监护病房的重症儿童，初级保健团队已选择放置双层或三腔股静脉导管。 放射学研究者将在导管插入后的2天内对导管股静脉进行超声检查，并在从医院出院之前进行最终研究。 主要结果变量是硝酸甘油和D5W组之间超声诊断性血栓形成的发生率的差异。 次要结果变量包括两组之间血栓形成的临床证据，两组之间导管相关感染的发生率的差异，TPN，脂质内和肝素输注对每组血栓形成的影响以及导管持续时间对每组血栓形成的影响。迄今为止，已经招募了62名所需参与者中的40名。 入学率一直是一个有限因素，但是如果我们可以每月平均每月注册2个，则该研究可以在12个月内完成。 通过对研究员的更积极的教育以及研究协调员的可用性增加，可以增加入学率。 目前没有临时结果。