Study of Changes on Mean Systemic Filling Pressure (Pmsf) in Post-surgical Patients After a Fluid Challenge: Looking for the Minimal Dose of Fluids
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Proportion of Responders by dose group
研究概览
简要总结
This study evaluate the effect of different doses of crystalloids on the changes on cardiac output (CO) and on the proportion of responders and non-responders and aims to determine the minimal volume required to increase the mean systemic filling pressures (Pmsf) in post-cardiac surgical patients.
详细描述
OBJECTIVES
-
To determine if different doses of fluids in a fluid challenge affect the change in CO and the proportion of responders / non-responders
-
To determine the minimal amount of volume required for performing an effective fluid challenge.
-
To define the least significant change of the Pmsf measured by Pmsf-arm.
-
To define the stop-flow time required to measure Pmsf-arm
-
To study the changes generated by a fluid challenge in the microcirculation and correlate those changes with the changes in the Pmsf.
STUDY DESIGN
- TYPE OF STUDY This is an quasi-randomised open-label study. The purpose of this study is non-commercial.
- STUDY OF MINIMAL VOLUME Once the participant is admitted to the ICU, and the monitors are in place, the fluid challenge will be administered. Each fluid challenge will be administered with a syringe (50 ml) in five minutes. In order to observe the effect of the volume on Pmsf-arm, the total sample of patients will be divided in 4 groups: in group one Pmsf-arm will be measured at baseline and after 1 ml/kg of body weight; in group 2 after 2 ml/Kg; in group 3 after 3 ml/kg and finally in group 4 after 4 ml/Kg. The fluid challenge will be completed in everybody after the measurement of Pmsf-arm, in order to respect clinical practice. Pmsa will be observed also. The total duration of the fluid challenge will be 5 minutes. The fluid challenge will be repeated in accordance with the clinical protocol or with the clinician advice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 接受健康志愿者
- 否
入选标准
- •Patients admitted to the general or cardiothoracic intensive care unit, requiring fluid therapy guided by the current clinical protocol.
排除标准
- •Extensive peripheral arterial occlusive disease in upper limbs.
- •Postoperative valvular insufficiency
- •Aortic valve regurgitation
- •Arrhythmia
- •Cardiac assist device (Intra-Aortic balloon pump)
- •Right ventricular failure
- •Patients without capacity to consent for themselves Also, patients requiring aggressive fluid resuscitation due to life-threatening cardiovascular instability and pregnant women will be excluded from the study.
研究组 & 干预措施
1 ml / Kg
Patients receive a Fluid challenge with Compound Sodium Lactate 1 ml/Kg IV over 5 minutes
干预措施: Fluid challenge with Compound Sodium Lactate (Drug)
2 ml/Kg
Patients receive a Fluid challenge with Compound Sodium Lactate 2 ml/Kg IV over 5 minutes
干预措施: Fluid challenge with Compound Sodium Lactate (Drug)
3 ml/Kg
Patients receive a Fluid challenge with Compound Sodium Lactate 3 ml/Kg IV over 5 minutes
干预措施: Fluid challenge with Compound Sodium Lactate (Drug)
4 ml/Kg
Patients receive a Fluid challenge with Compound Sodium Lactate 4 ml/Kg IV over 5 minutes
干预措施: Fluid challenge with Compound Sodium Lactate (Drug)
结局指标
主要结局
Proportion of Responders by dose group
时间窗: 15 minutes
Proportion of responders to a fluid challenge by dose of crystalloids according to CO response (greater than 10% change in CO is a positive response)
次要结局
- Change in Pmsf by dose of fluids(15 Minutes)
- Minimal dose of fluids(15 Minutes)