Hypertonic Saline Resuscitation for Early Closure of Open Abdomen in Trauma Patients
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Abdominal wall closure
研究概览
简要总结
This study aimed to determine whether hypertonic saline solution is effective in the resuscitation of injured patients undergoing abdominal damage control surgery regarding early closure of the abdominal wall.
详细描述
A double-blind, controlled, randomized clinical trial was conducted to determine the impact of an infusion of hypertonic saline 3% vs. isotonic saline 0.9% at a dose of 50 mL/hr for the first 72 hours in patients with abdominal trauma requiring damage control surgery regarding some clinically relevant outcomes. These outcomes were: The timing of abdominal cavity closure, fluids balance, abdominal hypertension, and abdominal compartment syndrome occurrence, organ dysfunction, and 28 days' mortality.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Abdominal trauma requiring damage control surgery.
- •Acceptance by the patient or by a proxy to be included in the trial.
排除标准
- •Concomitant severe head trauma, defined by a Glasgow score <9, before receiving sedation or by the presence of cerebral edema or intracranial injury on a CT-scan.
- •Pregnancy
- •Patient not included 4 hours or more after damage control surgery.
- •Damage control laparotomy performed for other indications other than trauma.
- •Not index damage control laparotomy
- •No acceptance to participate in the study.
研究组 & 干预措施
Sodium Chloride [3%]
干预措施: Sodium Chloride [3%] (Drug)
Sodium Chloride [0.9%]
干预措施: Sodium Chloride [0.9%] (Drug)
结局指标
主要结局
Abdominal wall closure
时间窗: 7 days
Proportion of patients in which closure of abdominal wall was achieved in the first 7 days after injury.
次要结局
- Fluid Balance measured in cm3(72 hours)
- Incidence of Abdominal compartment syndrome(7 days)
- Incidence of Organ Failure(7 days)
- Mortality(28 days)
研究者
Alberto Federico García
MD.
Fundacion Clinica Valle del Lili