A Randomized Controlled Trial of Crystalloid Alone Versus Crystalloid Plus Colloid in Shock Resuscitation
试验速览
- 阶段
- 不适用
- 入组人数
- 320
- 试验地点
- 1
- 主要终点
- Proportion of patients who had shock reversal
研究概览
简要总结
Fluid resuscitation is the most effective treatment of shock. Isotonic crystalloid solution is the current recommended initial fluid resuscitation. However, this kind of fluid has high volume of distribution and may require large volume administration before achieve therapeutic goal of shock reversal. There are rising concern about the delay in shock reversal and adverse consequences of large amount volume of fluid therapy. Colloid fluid have been used as the alternate fluid resuscitation, aiming to limit the volume of fluid resuscitation and promote shock reversal. Whether colloid infusion can improve shock reversal rate and decrease complication associated with fluid resuscitation, had inconclusive information.
详细描述
Fluid resuscitation is the most effective treatment of shock. Isotonic crystalloid solution is the current recommended initial fluid resuscitation. However, this kind of fluid has high volume of distribution and may require large volume administration before achieve therapeutic goal of shock reversal. There are rising concern about the delay in shock reversal and adverse consequences of large amount volume of fluid therapy. Colloid fluid have been used as the alternate fluid resuscitation, aiming to limit the volume of fluid resuscitation and promote shock reversal. Data from a recent randomized controlled study showed the improve long term survival among shock patients whose resuscitated with colloid solution. There were evidence about the increase incidence of acute kidney injury among critically ill patients who received hydroxyethyl starch, a previously worldwide used colloid solution. For septic shock, the leading cause of shock in current situation, resuscitation with albumin may associated with better outcome, while increasing mortality had been reported among the patient who received hydroxyethyl starch. Whether colloid infusion can improve shock reversal rate and decrease complication associated with fluid resuscitation, had inconclusive information.
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
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 at least 18 years old
- •New onset of shock within 24 hours
- •Mean arterial blood pressure less than 65 mmHg or systolic blood pressure less than 60% of patient's baseline blood pressure
- •Evidence of poor tissue perfusion including: urine output less than 0.5 mL/kg/hr, lactate more than 2 mmol/L, alteration of consciousness without other explanation
- •Evidence of fluid inadequacy (CVP < 12 mmHg, Pulmonary capillary wedge pressure < 18 mmHg) or evidence of fluid responsive (IVC diameter variation > 15%, pulse pressure variation > 15%, positive fluid challenge test)
排除标准
- •Prolong shock more than 24 hours
- •Received colloid solution more than 1,000 mL in previous 72 hours
- •Do not resuscitation documented patient
- •Contraindication for fluid therapy including: suspected cardiogenic shock, evidence of pulmonary edema, history of anaphylaxis after fluid therapy
研究组 & 干预措施
Crystalloid
Isotonic crystalloid solution resuscitation
干预措施: Isotonic crystalloid solution resuscitation (Drug)
Crystalloid plus Colloid
Colloid solution resuscitation
干预措施: Isotonic crystalloid solution resuscitation (Drug)
Crystalloid plus Colloid
Colloid solution resuscitation
干预措施: Colloid solution resuscitation (Drug)
结局指标
主要结局
Proportion of patients who had shock reversal
时间窗: 6 hours after initial resuscitation
Shock reversal was defined by mean arterial blood pressure \> 65 mmHg plus lactate clearance more than 10%
次要结局
- Hospital mortality(90 days)
- Total fluid resuscitation within 24 hours(24 hours)
- Mortality rate(28 days)
- Renal replacement therapy(28 days)
研究者
Surat Tongyoo
Assistant Professor
Mahidol University