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临床试验/NCT02447042
NCT02447042已完成不适用

Study of Changes on Mean Systemic Filling Pressure (Pmsf) and Microcirculation After a Fluid Challenge in Septic Patients: Looking for the Minimal Volume

St George's, University of London2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2014年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
2
主要终点
Change in Pmsf-arm (expressed in percentage from baseline value)

研究概览

简要总结

The administration of fluids intravenously is the first step in the stabilization of patients in septic shock. It is important to give the right dose of fluids, enough to improve the function of the cardiovascular system but not too much to drown the cells in water. In order to know that, the investigators use the "fluid challenge" which is the administration of a "small amount" of fluid in a short period of time in order to test the cardiovascular response to a dose of fluids. However, it is unclear how "small" this amount can be. The aim of this study is to find out the minimum volume required to perform an effective "fluid challenge". The investigators hypothesize that the changes in the mean pressure in the cardiovascular system (socalled mean systemic filling pressure or Pmsf) during the administration of small amounts of fluid can be used to detect the minimum volume required to effectively test the cardiovascular system with a fluid challenge.

On the other hand, microcirculation may remain impaired despite the stabilization of the macrocirculation. The microcirculation can be much more dynamic than the macrocriculation, so it is essential to observe the changes of both over time. Patients admitted at the investigators' intensive care unit (ICU) due to sepsis can be included in this study. The sample will be divided in 4 groups according to the volume of the fluid challenge: 2 ml/kg, 3 ml/kg, 4ml/Kg and 5 ml/kg.

The investigators will measure the Pmsf non-invasively using a pneumatic tourniquet inflated during one minute. Invasive arterial blood pressure will be observed during the inflation of the cuff in the arm to determine the Pmsf. The least significant change of Pmsf using this method is 14%. The minimal volume will be that one that achieve that change in Pmsf.

详细描述

PURPOSE AND DESIGN The main objective of this study is to find out the minimum volume of fluid required to perform an effective "fluid challenge" in septic patients. An effective fluid challenge would be one that is able to increase the mean pressure in the cardiovascular system when there is no blood circulation or socalled the mean systemic filling pressure (Pmsf). It is similar to the pressure into a pneumatic tyre, which is only related to the volume of air and the elastic properties of the tyre wall. In order to do this, the investigators will observe the changes in mean systemic filling pressure after small amounts of fluids so that the investigators will be able to realise how much volume is required to increase that pressure.

To assure that the change in Pmsf is a real change, the investigators have conducted a pilot study in order to determine the precision of the Pmsf measurement using the Pmsf-arm technique. The least significant change is about 14 % from baseline measurement. The Pmsf-arm technique is a process very similar to that the investigators use to measure non-invasive blood pressure. The investigators will measure the arterial-venous equilibrium pressure in the arm after a rapid and brief interruption of blood circulation. In order to do this, a totally noninvasive automatic tourniquet is attached to the arm where the arterial line has been inserted and the tourniquet is inflated during 60 seconds. This process will be done at baseline and after the fluid challenge. The second objective is observe the microcirculation during an affective fluid challenge and correlate the changes observed with the changes in the cardiac function and the Pmsf.

The third objective is to observe the changes generated by the vasoactive therapy in the macro and microcirculation according to the cardiac response and the type of vasoactive therapy used.

In the investigators' clinical practice, the investigators have observed that in some cases the infusion of 250 ml of fluid has no impact at all in the cardiovascular function. The investigators believe that in those cases the investigators may have not given enough fluid to increase the Pmsf and test the cardiovascular response.

RECRUITMENT The sample will be recruited by convenience. It is important to understand the difference between fluid resuscitation and fluid challenge. The fluid resuscitation requires normally large amount of volume in a medical emergency in order to achieve cardiovascular stability. Once the patient is minimally stable, a fluid challenge is normally carried out in order to find out if the patient may benefit from more fluids. As the performance of a fluid challenge is part of the normal clinical practice once the patient has been admitted to ICU, there is minimal extra risk from participation in this study.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Fulfil 2 of 4 of the criteria of the systemic inflammatory response syndrome (SIRS) due to known or suspected infection within the previous 24 hours. The SIRS criteria are:
  • Core temperature >38 °C or < 36 °C
  • Tachycardia (heart rate > 90 beats per minute)
  • Tachypnoea (respiratory rate >20 breaths per minute or PaCO2 < 4.3 kPa or need for mechanical ventilation)
  • Abnormal white cell count (> 12000 cells/mm3 or < 4000 cells/mm3, or >10% immature (band cells) forms.

排除标准

  • Extensive peripheral arterial occlusive disease in upper limbs.
  • Postoperative valvular insufficiency
  • Aortic valve regurgitation
  • Tachyarrhythmia
  • Cardiac assist device (IntraAortic balloon pump)
  • Previously known right ventricular failure
  • Known vasospastic diseases, systemic sclerosis or Raynaud's phenomenon.
  • Patients requiring aggressive fluid resuscitation due to lifethreatening cardiovascular instability
  • Known pregnant women.

结局指标

主要结局

Change in Pmsf-arm (expressed in percentage from baseline value)

时间窗: Inmediately after end of fluid infussion

次要结局

  • Change in cardiac output (expressed in percentage from baseline value(Inmmediately after end of fluid infussion)
  • Proportion of responders in each group(As average three moths after end of the study)

研究者

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

HollmannAya

Research Fellow Intensive Care Directorate

St George's, University of London

研究点 (2)

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