Effect of Colloids Versus Crystalloids on Heart Mechanics: a Double-blind Cross Over Randomized Trial
试验速览
- 阶段
- 3 期
- 状态
- Enrolling By Invitation
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Heart mechanics response will be assessed by using left ventricular longitudinal strain, left ventricular torsion strain curves, left atrial strain curves and right ventricular free wall strain curves
研究概览
简要总结
The debate over whether to use colloid or crystalloid solutions for fluid resuscitationis still ongoing. Colloid solutions consist of large molecules that generally cannot pass through healthy capillary membranes, whereas crystalloid solutions contain ions that easily move from the intravascular space to the interstitial compartment. Therefore, it is traditionally argued that colloids are more effective at expanding intravascular volume, with a suggested ratio of 1:3 compared to crystalloids. However, there is currently limited evidence to suggest that resuscitation with one type of fluid is more effective or safer than t he other. Despite these theoretically advantageousphysiological properties, colloids have not demonstrated a clear hemodynamic benefit over crystalloids. We hypothesized that these unexpected discrepancies may be attributed to different mechanical heart responses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •HealthyVolunteers with age > 18 years without medical history
排除标准
- •History of cardio vascular diseases Diabetes Hypertension Currentpregnancy Knownallergy to one of the tested products Leftventricular dysfunction discovered at baseline assessment Valvular heart or other structural diseases discovered at base line assessment
研究组 & 干预措施
AB
Patients will blindly receive colloids then after a washout period of 7 days a cristalloids solute will be administered
干预措施: Gelafundin (Drug)
AB
Patients will blindly receive colloids then after a washout period of 7 days a cristalloids solute will be administered
干预措施: Saline (NaCl 0,9 %) (placebo) (Drug)
BA
Patients will blindly receive cristalloids then after a washout period of 7 days a colloids solute will be administered.
干预措施: Gelafundin (Drug)
BA
Patients will blindly receive cristalloids then after a washout period of 7 days a colloids solute will be administered.
干预措施: Saline (NaCl 0,9 %) (placebo) (Drug)
结局指标
主要结局
Heart mechanics response will be assessed by using left ventricular longitudinal strain, left ventricular torsion strain curves, left atrial strain curves and right ventricular free wall strain curves
时间窗: 1 day
次要结局
未报告次要终点
研究者
Nidhal Bouchahda
Dr Nidhal Bouchahda
University of Monastir
