Comparison of Balanced Crystalloids and Normal Saline in Septic Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Development of kidney injury as defined by the KDIGO criteria.
研究概览
简要总结
In this prospective randomized controlled trial, investigators attempt to study the effects of acetated Ringer's solution on the prognosis and renal function of patients with sepsis in intensive care unit compared with normal saline, and provide evidence for current fluid resuscitation strategies for sepsis.
详细描述
During the study period，either normal saline or acetated Ringer's solution will be assigned as resuscitation fluid to the septic patients meeting the inclusion criteria.It is anticipated that about 500 patients will be enrolled during the study period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed sepsis aged 18~75 and accepted therapy in ICU
排除标准
- •Need of Renal replacement treatment
- •End-stage renal failure
- •pregnant woman
研究组 & 干预措施
0.9% saline
We use 0.9% saline for resuscitation fluid in ICU septic patients
干预措施: 0.9% saline (Drug)
Balanced Crystalloids
We use acetated Ringer's solution for resuscitation fluid in ICU septic patients
干预措施: lactated Ringer's solution (Drug)
结局指标
主要结局
Development of kidney injury as defined by the KDIGO criteria.
时间窗: 5 days after the admission
Investigators will use the level of creatinine(μmol/L) and body weight adjusted urine(ml/h/kg) for severity assessment of kidney injury
Need of renal replacement treatment
时间窗: After the admission and before the discharge from ICU,average 15 days
Investigators will assess patients' kidney function everyday
次要结局
- ICU stay(After the admission and before the discharge from ICU,average 15 days)
- 28 days mortality(28 days after the admission in ICU)
研究者
ZhiYong Peng
Professor
Zhongnan Hospital