Prophylactic Ethanol Lock Therapy (ELT) in Patients on Home Parenteral Nutrition: A Prospective Randomized Control Trial.
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Mayo Clinic
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Number of Catheter-Related Blood Stream Infections
研究概览
简要总结
This study is being implemented to identify the role of prophylactic use of ethanol lock in adult patients on home parenteral nutrition (HPN). Central catheter related blood stream infection is a major complication in patients on HPN. The investigators hypothesize that the prophylactic use of ELT will decrease the number of catheter related blood stream infections compared to the control group. The investigators further hypothesize that with the introduction of prophylactic ELT, the number of infections will decrease.
详细描述
Catheter-related bloodstream infection (CRBSI) is a serious complication for home parenteral nutrition (HPN) patients causing morbidity, mortality, and prolonged hospitalization. CRBSIs may also result in the need for central venous catheter (CVC) removal and replacement. Current literature supports the use of antibiotics locks in patients with repeated CRBSI. There is a growing concern about the increased risk of microbial resistance with the long term use antibiotic locks. Ethanol lock therapy (ELT) has broad spectrum coverage and includes gram negative bacteria, gram positive bacteria, atypical bacteria, and fungi. Compared with antibiotic and other solution locks, which have limitations, ELT has excellent broad-spectrum bactericidal and fungicidal killing action and poses no problems with development of resistance over time. There is a lack of a randomized controlled study to characterize the role of ELT in adult patients on HPN.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly started on Home parenteral Nutrition and anticipated duration >3 months.
- •Not previously on Home Parenteral Nutrition.
- •Providing consent.
- •Patients with non-medicare insurance.
- •Patients with medicare insurance and a supplementary insurance.
- •Patients with single lumen Hickman® catheters.
- •No known alcohol addiction.
排除标准
- •Failure to provide consent
- •Patients with medicare insurance and no other supplemental private insurance
- •Patients with a catheter type other than a single lumen Hickman®
- •Patients who are on HPN for less than three months
- •Pregnant patients
- •Patients who have previous proven addiction and dependence to alcohol.
- •Patients lacking capacity to provide consent
- •Patients who are not be managed by HPN team at investigator's institution
研究组 & 干预措施
Ethanol Lock and Normal Saline
All patients randomized to the ELT group will receive 3ml of 70% ethanol and saline flush.
干预措施: Ethanol (Drug)
Ethanol Lock and Normal Saline
All patients randomized to the ELT group will receive 3ml of 70% ethanol and saline flush.
干预措施: Normal Saline (Drug)
Heparin and Normal Saline
All patients randomized to this group will receive Heparin lock + saline infusion (current standard of care).
干预措施: Heparin Lock (Drug)
Heparin and Normal Saline
All patients randomized to this group will receive Heparin lock + saline infusion (current standard of care).
干预措施: Normal Saline (Drug)
结局指标
主要结局
Number of Catheter-Related Blood Stream Infections
时间窗: 1 year
The most common complication in parenteral nutrition is catheter-related blood stream infection (CRBSI), which can lean to increased morbidity, mortality, and prolonged hospitalizations. CRBSI was defined as bacteremia or fungemia in a patient who had an intravascular device and \>1 positive blood culture result obtained from the peripheral vein, clinical manifestations of infection (e.g., fever, chills, and/or hypotension), and no apparent source for blood stream infection other than the central venous catheter.
次要结局
未报告次要终点
研究者
Ryan T. Hurt, M.D., Ph.D.
Associate Professor of Medicine
Mayo Clinic