Acupuncture to Improve Outcomes in Sepsis Patient: The ACTIONS Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Number of participants recruited compared to the number of participants who complete study treatment.
研究概览
简要总结
Researchers think acupuncture may improve outcomes for participants with sepsis, based on laboratory studies and previous studies in people with sepsis. The purpose of this study to see whether real acupuncture can improve outcomes for participants with sepsis when compared to sham acupuncture. Sham acupuncture is performed the same way as real acupuncture but will use different needles and target different sites or places on the body than real acupuncture.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Patient's inpatient clinical care team.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 or older
- •Having a sepsis order-set placed within the previous 48 hours
排除标准
- •The study Principal Investigator will review the medical record again prior to enrollment to exclude non-sepsis patients (Even though the placement of sepsis order set already screens out such patients, subsequent clinical development after sepsis order set placement may generate new information that deems the patient not septic.)
- •Admitted to ICU before being approached for consenting
- •Having an implanted medical device, such as a pacemaker or implantable cardioverter-defibrillator (ICD), with which electroacupuncture
- •Unable to obtain informed consent due to a participant's mental status and absence of an individual authorized to give consent on the participant's behalf
- •The patient is on an interventional clinical trial and its Principal Investigator does not give approval to enrollment to this study (e.g. genomic profiling, biospecimen, or observational studies do not require PI approval).
研究组 & 干预措施
Acupuncture
干预措施: Acupuncture (Procedure)
Sham Acupuncture
干预措施: Sham Acupuncture (Other)
结局指标
主要结局
Number of participants recruited compared to the number of participants who complete study treatment.
时间窗: Up to 2 years
To assess the feasibility of conducting a randomized controlled trial of acupuncture in hospitalized patients who are at risk for sepsis.
Admission/transfer to ICU
时间窗: Within 30 days
Deterioration of a participant's clinical condition that necessitate an admission or transfer to an Intensive Care Unit (ICU)
次要结局
- Mortality(30 days)
研究者
Gary Deng
Professor of Medicine
University of California, Irvine