跳至主要内容
临床试验/NCT06900972
NCT06900972Enrolling By Invitation3 期

Effect of Colloids Versus Crystalloids on Heart Mechanics: a Double-blind Cross Over Randomized Trial

University of Monastir1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2025年4月1日最近更新:
干预措施
相关药物

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

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

Other

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

Other

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

Other

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

Other

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nidhal Bouchahda

Dr Nidhal Bouchahda

University of Monastir

研究点 (1)

Loading locations...

相似试验