Hydrochloric Acid Lock Therapy for Central Line-associated Bloodstream Infections in Patients With Cancer and Hematologic Diseases
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 212
- 试验地点
- 4
- 主要终点
- Treatment failure.
研究概览
简要总结
Aim: This study will test whether treatment of central line-associated bloodstream infections (CLABSI) with hydrochloric acid lock therapy (HALT) can significantly reduce the risk of treatment failure (comprising failure to clear initial infection, relapse of infection, or reinfection) in patients treated for cancer or hematologic diseases.
Study design: A multicentre, double-blinded, randomized controlled trial. Patient population: Patients (0-100 y) with cancer or a hematologic disorder and a CLABSI treated at Copenhagen University Hospital, Aarhus University Hospital, or Odense University Hospital, Denmark.
Randomization: Patients are equally assigned (1:1) to receive either HALT or placebo (normal saline). In addition to the study intervention, patients in both arms will receive standard systemic antibiotic therapy.
Sample size: A target population of 250 patients
Statistical Analysis Plan is uploaded in "Study Documents"
详细描述
BACKGROUND
Patients with cancer or hematologic diseases and a long-term central venous access device (CVAD), including central venous catheters and intravenous ports, are at risk of developing central line-associated bloodstream infections (CLABSI). A patient with CLABSI is treated with systemic antibiotic therapy. Additionally, prompt removal of the CVAD because of CLABSI is often recommended. However, removal and replacement of a long-term CVAD is an invasive procedure and not always possible. Therefore, various types of lock therapies have been tried in attempt to cleanse and preserve the CVAD.
At more hospitals in Denmark, hydrochloric acid lock therapy (HALT) has been used routinely for patients with cancer and hematologic diseases and a CLABSI. However, HALT is not recommended outside Denmark due to limited evidence of its use.
PATIENT AND METHODS
Eligible patients with CLABSI will be enrolled during antibiotic therapy and a maximum of 5 days after the detection of a positive blood culture/CLABSI. The patients will be randomized to receive blinded lock therapy with hydrochloric acid (2 M) or placebo (normal saline). HALT and placebo lock therapy is carried out by trained oncologic nurses in identical fashion: Hydrochloric acid or normal saline in a volume corresponding to dead space (0.3-1.8ml) will be instilled and aspirated 10 min later; the instillation is completed 3 times. In addition to the study intervention, patients in both arms will receive standard systemic antibiotic therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The study will be blinded using masked vial containing either hydrochloric acid or normal saline and coloured syringes. All masked vials have a unique three-figure randomization code.
入排标准
- 年龄范围
- 0 Years 至 100 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 0-17 years treated at pediatric oncologic department at Copenhagen University Hospital, Odense University Hospital, and Aarhus University Hospital, Denmark. Inclusion of children and adolescents from 1st of June
- •Patients aged 18-100 years treated at Department of Hematology, Copenhagen University Hospital, Denmark. Inclusion of adult patients from 17th of October
- •Patients receiving treatment for cancer or a hematologic disease (any type and at any point in the course of the disease).
- •CVAD in situ (intravenous ports and all central lines).
- •New diagnosis of CLABSI (defined as a laboratory-confirmed bloodstream infection, not secondary to infection at another site, in a patient who has a CVAD). NB, patients who had a CLABSI prior to the beginning of the study are accepted for enrollment if they have a new CLABSI during the patient enrollment phase.
- •The patient is followed 6 weeks from instillation with HALT/placebo. The patient can be re-included if the patient has 1) replacement of the CVAD, or 2) a new CLABSI later than 6 weeks from a previous CLABSI. In case of re-inclusion the patient, the patient will be randomized again.
排除标准
- •Plan to remove CVAD within 6 days.
- •Instantly admission to Intensive Care Uni
研究组 & 干预措施
Intervention group
Hydrochloric acid (2 M)
干预措施: Hydrochloric Acid (2 M) (Drug)
Control group
Normal saline
干预措施: Normal saline (Drug)
结局指标
主要结局
Treatment failure.
时间窗: Within 6 weeks after HALT or placebo (normal saline) treatment of the CVAD.
Defined as 1) persistent infection (persistent positive blood cultures 24 hours after HALT/placebo) or relapse (a new CLABSI with an identical bacterial isolate), 2) a new CLABSI with any bacterial isolate, 3) infection-related removal of central access device (CVAD), 4) infection-related death. The treatment group comparison will be based on a test of the risk ratio between the two groups.
次要结局
未报告次要终点
研究者
Mette Bondo Mønster
Principal Investigator, Department of Paediatrics and Adolescent Medicine, Copenhagen University Hospital, Denmark
Rigshospitalet, Denmark