The Effect of Critical Ultrasonography Guided Precise Fluid Management in Patients With Sepsis or Septic Shock: A Single-center Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 118
- 试验地点
- 1
- 主要终点
- 60-day all-cause mortality
研究概览
简要总结
This study aims to assess whether procedural critical ultrasonography guided precise fluid management (CUGP) can affect the clinical fluid management strategy and improve the outcomes of patients with sepsis or septic shock.
详细描述
This single-center parallel randomized controlled trial aims to assess whether procedural critical ultrasonography guided precise fluid management (CUGP) can affect the clinical fluid management strategy and improve the outcomes of patients with sepsis or septic shock. We planned to conduct this single-center trial in the intensive care unit (ICU) of Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology in Wuhan, China. Patients, who are initially diagnosed with sepsis, will be assessed for eligibility immediately upon admission to the ICU. Then, eligible participants will be informed and randomly assigned to one of the two groups: the CUGP group or the usual care group, in a 1:1 ratio using block randomization. In the CUGP group, ultrasonographic assessment was performed by a team of trained critical ultrasonography physicians at enrollment, 1 hour, 3 hours, 6 hours, 12 hours, 24 hours, 48 hours, and 72 hours thereafter, respectively. The usual care group used conventional hemodynamic monitoring methods for monitoring and decision-making about fluid management. The enrolled patients received either CUGP or usual care fluid management within 72 hours of enrollment in the ICU, and followed by 60 days after randomization. The primary outcome was the 60-day all-cause mortality. The secondary outcomes included SOFA score at 24, 48, and, 72 hours after enrollment, fluid infusion volume, vasoactive drug dosage, incidence of serious adverse events related to fluid management, including new tracheal intubation, severe acute kidney injury, electrolyte disturbance, and organ ischemia (brain, myocardium, gastrointestinal tract, limbs), incidence of complications related to central venous and arterial puncture, acute left heart failure, and pulmonary edema, monitoring failure rates of CUGP group and usual care group, ICU and hospital length of stay, cost of ICU stay/hospitalization. This study adopts a standardized data collection and management system. The study implementer shall fill in the paper or electronic CRF.
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
- Single (Outcomes Assessor)
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
- •1. Age ≥ 18 years old;
- •2. Estimated length of ICU stay ≥ 24 hours;
- •3. Diagnosis according to the Sepsis 3.0 criteria, which included:
- •a. suspected or confirmed infections supported by clinical evidence and/or positive microbiological findings;
- •b. the sepsis related organ failure assessment (SOFA) score ≥ 2.
排除标准
- •1. Patients were pregnant woman;
- •2. Patients had acute coronary syndrome;
- •3. Patients had acute pulmonary edema;
- •4. Patients had status asthmatics;
- •5. Patients had malignant arrhythmia;
- •6. Patients had active gastrointestinal bleeding;
- •7. Patients had epileptic seizure;
- •8. Patients had drug poisoning;
- •9. Patients had severe burns;
- •10. Patients had contraindications of blood transfusion;
- •11. Patients had intra-abdominal hypertension (intra-abdominal pressure increases continuously ≥ 12mmHg);
- •12. Patients had acute pulmonary embolism;
- •13. Patients had contraindications of leg raising;
- •14. Patients had cardiac structural or functional abnormalities (left ventricular outflow tract obstruction, moderate-to-severe mitral regurgitation, aortic regurgitation), it would seriously affect the velocity time integral of left ventricular outflow tract;
- •15. Patients or their legal representatives refused active treatment;
- •16. Patients or their legal representatives refused to participate in this study;
- •17. Patients were participating in other interventional clinical trials.
研究组 & 干预措施
CUGP group
In the CUGP group, ultrasonographic assessment was performed by a team of trained critical ultrasonography physicians at enrollment, 1 hour, 3 hours, 6 hours, 12 hours, 24 hours, 48 hours, and 72 hours thereafter, respectively.
干预措施: critical ultrasonography (Device)
usual care group
The usual care group used conventional hemodynamic monitoring methods for monitoring and decision-making about fluid management. Records were made at enrollment, 1 hour, 3 hours, 6 hours, 12 hours, 24 hours, 48 hours, and 72 hours thereafter, respectively.
结局指标
主要结局
60-day all-cause mortality
时间窗: At day 60 after randomization
It refers to the total number of patients who died from any cause within 60 days of enrollment. It will be described as a rate
次要结局
- Complications(Within 72 hours of admission)
- Fluid changes with 72 hours(Within 72 hours of admission)
- Length of ICU stays/hospitalization(Follow-up 60th day after enrollment)
- 72-hour SOFA Score(At baseline (before randomization), 24 hours, 48 hours, and 72 hours thereafter.)
- Fluid management for decision(Within 72 hours of admission)
- Serious adverse events(Follow-up 60th day after enrollment)
- Nosocomial infection during ICU stays(Follow-up 60th day after enrollment)
- Dosage of vasopressors changes with 72 hours(Within 72 hours of admission)
- Survival time(Follow-up after 60th day after enrollment)
- Cost of ICU stays/hospitalization(Follow-up 60th day after enrollment)
研究者
Shusheng Li
Professor
Tongji Hospital