NCT05463471尚未招募4 期
Effect of Balanced Saline Solution and Albumin on Volume Expansion in Shock Patients: a Prospective Randomized Controlled Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 500
- 主要终点
- Percentage of Cardiac output Index(CI) change
研究概览
简要总结
To compare the direct effect of sodium acetate ringer injection or albumin on volume expansion in shock patients, and to provide reference for volume resuscitation strategy in shock patients
详细描述
CI/SVI increase amplitude and maintenance time
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 ≥ 18 years old, gender unlimited
- •Shock requires volume resuscitation:
- •Insufficient tissue perfusion: wet and cold skin, decreased urine volume (<0.5ml/kg/h), change of consciousness, blood lactate >2.0mmol/l or vasoactive drugs are required to maintain map>65mmhg
- •Presence of volume reactivity: (under controlled ventilation) PPV ≥ 15% or passive leg raising test (+) or (under controlled ventilation) IVC variability ≥ 18% or the presence of volume reactivity as judged by clinicians
- •The patient has no obvious restlessness, RASS ≤ 0
- •The legal representative of the subject signs the informed consent form-
排除标准
- •Pregnant and lactating women
- •End stage patients
- •BMI ≤ 15 or BMI ≥ 50
- •Contraindication of indwelling central vein catheter and invasive arterial catheter
- •Patients in ECMO and / or IABP therapy
- •Hemorrhagic shock, blood products such as concentrated red blood cells, plasma and platelets will be infused within 1 hour
- •Myocardial infarction, NYHA grade IV
- •Patients with hyperkalemia, hypercalcemia, hypermagnesemia and hypothyroidism
- •Allergic to compound sodium acetate ringer injection or albumin or with known side effects
- •Other factors that may affect the monitoring and evaluation of relevant indicators
研究组 & 干预措施
sodium acetate ringer
Experimental
干预措施: Compound sodium acetate ringer injection (Drug)
albumin
Active Comparator
干预措施: Albumin (Drug)
结局指标
主要结局
Percentage of Cardiac output Index(CI) change
时间窗: 2 hour
The changes of cardiac output index before and after volume expansion were compared
Percentage of Stroke Volume Index（SVI）change
时间窗: 2 hour
The changes of Stroke Volume Index before and after volume expansion were compared
次要结局
- Duration of Cardiac output Index(CI) change(2 hour)
- Duration of Stroke Volume Index（SVI）change(2 hour)
研究者
相似试验
已完成
1 期
Hypertonic Saline Use in PreeclampsiaPreeclampsiaNCT00181077Johns Hopkins University20
已完成
不适用
Effects of Fluid Therapy on Peripheral TIssse Perfusion During Sepsis/Septic ShockSepsisSeptic ShockNCT05094856Assistance Publique - Hôpitaux de Paris61
Unknown
不适用
Acetated Ringer's Solution Versus Saline in Patients With Septic ShockSeptic Shock HyperdynamicNCT04507672Southeast University, China2,000
招募中
不适用
Application of Sodium Bicarbonate Ringer's Solution in Laparoscopic HepatectomyHepatic IschemiaNCT05830136The First Affiliated Hospital with Nanjing Medical University100
已完成
4 期
The Importance of Albumin Infusion Rate for Plasma Volume Expansion Following Major Abdominal SurgeryPancreatic NeoplasmsUrogenital NeoplasmHypovolemiaSystemic Inflammatory Response SyndromeNCT02728921Region Skane70