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临床试验/NCT04756427
NCT04756427已完成4 期

Sodium Citrate 4% Locking Solution for Children Requiring Home Parenteral Nutrition

Johns Hopkins University1 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2022年3月28日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
已完成
入组人数
1
试验地点
1
主要终点
Central Line-associated Bloodstream Infection (CLABSI) Rate

研究概览

简要总结

This study an open label prospective observational cohort study to evaluate the safety and efficacy of sodium citrate 4% locking solution in preventing central line associated blood stream infection in children requiring long term central venous catheters for home parenteral nutrition. Sodium citrate 4% is FDA-approved for dialysis catheters, but has not been formally evaluated for use in tunneled catheters for parenteral nutrition. The rate of central line-associated bloodstream infection (CLABSI) and other potential adverse events will be monitored for 12 months, with the option to remain in the study for a longer period of time.

详细描述

In this prospective observational cohort study of pediatric patients requiring home parenteral nutrition for intestinal failure, participants will be enrolled from the pediatric intestinal rehabilitation clinic, and data collection will be obtained from the electronic medical record. Participant will receive daily sodium citrate 4% catheter locking solution for CLABSI prophylaxis, instead of heparin locks. Participants will be monitored for 12 months for adverse events, including CLABSI. Participants will have the same routine laboratory schedule and monthly outpatient follow up. After 12 months, participants will be given the option to continue to use sodium citrate 4% locks after the initial study period if no serious adverse events have occurred. The investigators anticipate enrolling 10-15 participants per year and anticipate enrollment to continue for 3-5 years.

Sodium citrate locks: 3 ml vials of locking solution will be prepared by the infusion pharmacy using commercially available 4% sodium citrate IV fluid (available in 500 ml bags). The sodium citrate locks will be instilled into the central catheter daily during the period that parenteral nutrition is not infusing, and will be withdrawn and disposed of prior to resuming infusion of parenteral nutrition. If subjects are hospitalized, sodium citrate locks will be temporarily held during the duration of the inpatient stay, and will be resumed once the participant is discharged home.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

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

入选标准

  • Pediatric patients (<18 years) and adult patients (up to 21 years still in our clinic)
  • requiring long-term (>3 months) home parenteral nutrition due to intestinal failure/short bowel syndrome
  • has had at least one central line-associated blood stream infection

排除标准

  • known cardiac arrhythmias
  • hypersensitivity to citrate
  • pregnancy
  • receiving continuous parenteral nutrition (infusing over 24 hours)

研究组 & 干预措施

Sodium citrate 4%

Experimental

All enrolled participants will received the daily sodium citrate 4% locking solution for CLABSI prophylaxis intervention and be observed prospectively for adverse events

干预措施: Sodium Citrate 4% Inj Syringe 3Ml (Drug)

结局指标

主要结局

Central Line-associated Bloodstream Infection (CLABSI) Rate

时间窗: 12 months

Frequency of fever with positive central line blood culture events per central line days.

次要结局

  • Central Line Removal Rate(12 months)
  • Central Venous Catheter Thrombus Rate(12 months)
  • Number of Serious Adverse Events(12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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