Effect of Early Administration of Albumin 20% Versus Crystalloid During Resuscitation of Patient With Septic Shock: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Recovery from shock
研究概览
简要总结
Sepsis and septic shock are global health problems, leading to a high mortality rate. They are often associated with extremely low blood pressure and multiple organ dysfunctions, which are the main causes of death in critically ill patients. Fluid resuscitation is one of the most critical treatments for patients with sepsis and septic shock.
An early administration of an appropriate fluid to patients is considered the most effective way to increase blood pressure, improve tissue perfusion, and save their lives. Crystalloid fluids are a subset of intravenous solutions composed of mineral salts and other small, water-soluble molecules, including normal, isotonic or hypertonic saline, and various buffered solutions.
详细描述
Crystalloid fluids are a subset of intravenous solutions composed of mineral salts and other small, water-soluble molecules, including normal, isotonic or hypertonic saline, and various buffered solutions.
Colloid solutions are composed of various amounts of substances, for instance, albumin, hydroxyethyl starch, dextran, and gelatine. Although the current international guidelines from the Surviving Sepsis Campaign recommend crystalloids to perform the initial resuscitation, and the replacement with albumin on patients who require substantial amounts of crystalloids, the choice of the best type of resuscitation fluids is still under debate.
Albumin, in addition to its oncotic functions, has a variety of other properties, including binding and transport of various endogenous molecules, anti-inflammatory and anti-oxidative effects, and modulation of nitric oxide metabolism.These properties are particularly relevant in critically ill patients, especially in patients with sepsis.
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, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presence of septic shock that meets all the following Criteria: Clinically possible, probable, or microbiologically confirmed infection according to the definitions of the International-Sepsis- Forums (ISF), Despite adequate volume therapy, vasopressors are required to maintain mean arterial pressure (MAP) ≥ 65 mmHg for at least 1 hour, Serum lactate concentration > 2 mmol/l (18 mg/dl) despite adequate volume therapy.
- •Onset of septic shock less than 24 h prior to study inclusion.
- •Women of childbearing age: negative pregnancy test
排除标准
- •Moribund conditions
- •End of life decisions
- •Previous participation to this trial or any other interventional clinical trial
- •Known hypersensitivity to albumin or any component of the trial drug
- •Clinical conditions, where albumin administration may be unfavourable
- •Breast feeding
研究组 & 干预措施
Human Albumin Group
About 23 patients will be objected for resuscitation with 60 gm (300 ml) human albumin 20% (HA 20%) over 2-3 hours combined usual practice with 30 ml/kg crystalloid.
干预措施: Albumin Human (Drug)
Control Group
About 23 patients will be objected for resuscitation with 30 ml/kg crystalloid.
干预措施: Albumin Human (Drug)
结局指标
主要结局
Recovery from shock
时间窗: 3 Hours
A reversal of hypotension (MAP) at the end of the first three hours of the resuscitation period.
次要结局
未报告次要终点