Septic Shock Management Guided by Ultrasound: A Randomized Control Trial (SEPTICUS Trial)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 340
- 试验地点
- 2
- 主要终点
- Number of mortality
研究概览
简要总结
This clinical study aims to compare the recent septic shock management protocol from American College of Critical Care Medicine (ACCM) to Ultrasound-guided Septic Shock Management (USSM) protocol. USSM protocol laid on Doppler ultrasonography to evaluate stroke volume, cardiac index, and systemic vascular resistance in each step of management to decide the proper fluid resuscitation and vasoactive therapy; differs from ACCM protocol which use clinical finding in its early step. ACCM protocol application elicits risk of improper therapy since clinical sign per se often could not describe the certain cardiac output. This can be prevented earlier by USSM protocol. The outcome compared of the two protocols is: mortality rate, clinical parameter, macrocirculation hemodynamic parameter, laboratory microcirculation parameter, and signs of fluid overload. The investigators hypothesized if the USSM protocol had a better outcome and less fluid overload complication.
详细描述
This study is a randomized controlled trial to compare the usage of ACCM protocol and USSM protocol in fluid resuscitation for septic shock pediatric patients. The USSM protocol is the intervention, and the ACCM protocol is the control. This study implemented in septic shock pediatric patients treated in the intensive care unit. Each patient will be randomized into 2 groups, the USSM group or the ACCM group. In the initial step, all patient in each group will receive early acute/emergency therapy: oxygen support, vascular access, and fluid resuscitation. The monitoring of the patient including clinical parameters and laboratory examination for both groups, except Doppler ultrasonography that performed in each step of management of the intervention group. The monitoring is performed every 15 minutes in the first hour of resuscitation. If the patient show good response (fluid responsive shock), the monitoring stops in 1 hour. In contrast, if the patient reveal fluid refractory shock, the vasoactive agent will be administered and monitoring continues until 6 hours. All outcome parameters, except mortality rate, will be recorded at 6 hours. The mortality rates will be recorded at 72 hours and time of intensive care discharge.
Sample size in this study was calculated by clinical trial formula for mortality rate with a significance level of 0.05 and study power of 0.2. From the calculation, the subject needed is 170 patients for each group (total 340 subjects). The basic characteristics of the patient will be analyzed descriptively. All parameter data will be analyzed statistically by Statistical Product and Service Solution (SPSS) 20, preceded by normality test and homogeneity test. The study analysis will be intention-to-treat. The mortality rate was analyzed by Kaplan-Meier survival analysis. Data transformation will be performed if needed in case of outlier data or out-of-range results.
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
- None
盲法说明
Outcome of mortality rate, macrocirculation hemodynamic parameter, and microcirculation laboratory parameter are objective measurement (does not influenced by assessors's subjectiveness).
However, the assessor of liver enlargement and lung US score will not be masked.
入排标准
- 年龄范围
- 1 Month 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosed as septic shock according to Pediatric Surviving Campaign (2005)
排除标准
- •patient with uncorrected congenital heart disease with shunting
- •obtain fluid resuscitation before recruitment process
- •obtain inotropic-vasoactive agent before recruitment process
- •after undergo any heart surgery
结局指标
主要结局
Number of mortality
时间窗: 72 hours of the initial fluid resuscitation
Amount of non-survivor subject, comparing intervention and control group.
Mortality rate
时间窗: 72 hours of the initial fluid resuscitation
Time of mortality occurrence since randomization, comparing intervention and control group.
次要结局
- Mean arterial pressure(1 hour in fluid-responsive subject or 6 hour in fluid-refractory subject after fluid resuscitation initiated)
- Stroke volume index(1 hour in fluid-responsive subject or 6 hour in fluid-refractory subject after fluid resuscitation initiated)
- Cardiac index(1 hour in fluid-responsive subject or 6 hour in fluid-refractory subject after fluid resuscitation initiated)
- Vasoactive-inotropic score (VIS)(1 hour in fluid-responsive subject or 6 hour in fluid-refractory subject after fluid resuscitation initiated)
- Capillary refill time(1 hour in fluid-responsive subject or 6 hour in fluid-refractory subject after fluid resuscitation initiated)
- Peripheral pulse strength(1 hour in fluid-responsive subject or 6 hour in fluid-refractory subject after fluid resuscitation initiated)
- Systemic vascular resistance index(1 hour in fluid-responsive subject or 6 hour in fluid-refractory subject after fluid resuscitation initiated)
- Base deficit(1 hour in fluid-responsive subject or 6 hour in fluid-refractory subject after fluid resuscitation initiated)
- Blood lactate level(1 hour in fluid-responsive subject or 6 hour in fluid-refractory subject after fluid resuscitation initiated)
- Lung ultrasound score(1 hour in fluid-responsive subject or 6 hour in fluid-refractory subject after fluid resuscitation initiated)
- Heart rate(1 hour in fluid-responsive subject or 6 hour in fluid-refractory subject after fluid resuscitation initiated)
- Systolic blood pressure(1 hour in fluid-responsive subject or 6 hour in fluid-refractory subject after fluid resuscitation initiated)
- Liver span increase(1 hour in fluid-responsive subject or 6 hour in fluid-refractory subject after fluid resuscitation initiated)
研究者
Saptadi Yuliarto
Head of Pediatric Emergency and Intensive Care Department
University of Brawijaya