跳至主要内容
临床试验/NCT02912624
NCT02912624已完成不适用

Combining Conventional With Advanced Hemodynamic Parameters for Predicting the Outcome of Critically Ill Patients: a Pilot for a Registry

University Medical Center Groningen1 个研究点 分布在 1 个国家目标入组 1,090 人开始时间: 2015年3月27日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,090
试验地点
1
主要终点
The association of a single or combination of clinical examination findings with cardiac index measured with transthoracic ultrasonography

研究概览

简要总结

Circulatory shock is a condition of generalized inadequate blood flow through the body, leading to insufficient tissue perfusion and inadequate delivery of oxygen and other nutrients, to the extent that tissues are damaged. Four basic mechanisms of circulatory failure are distinguished, caused by a scale of underlying illnesses: distributive, hypovolemic, obstructive and cardiogenic shock. The last three types are characterized by a low cardiac output and hypovolemia. Distributive shock is characterized by peripheral circulation failure, with a low systemic vascular resistance, a disturbed microcirculation and a high cardiac output. Frequently, these forms overlap.

Shock is a common problem in the intensive care unit (ICU) as it affects about one third of the patients. Septic shock appears to be the most common type, followed by cardiogenic and hypovolemic shock. The diagnosis of shock is based on clinical examination with use of well-known circulatory parameters such as blood pressure and heart rate; biochemical parameters such as lactate and direct (semi-)invasive measurement of cardiac output and other variables.

Since cardiac output is an important determinant of oxygen delivery, many different methods of measuring cardiac output have been suggested. These methods range from non-invasive to invasive measurements with central lining. The most invasive method, the pulmonary artery catheter (PAC) has long been considered the optimal form of monitoring cardiac output by using thermodilution. However, this technique is associated with adverse events, such as bleeding, and there is no clear evidence of improved outcome. Therefore, numerous other techniques have been proposed, ranging from systems that use the dilution technique but only require central venous and peripheral artery lines; to less invasive tools that estimate cardiac output based on the arterial pressure waveform; and to non-invasive echocardiography.

Despite technical advances, much remains unknown about the value of conventionally used hemodynamic parameters for estimating cardiac output. A distinction between macro- and microcirculatory parameters can be made. Commonly used macro-circulatory parameters are heart rate, systolic and diastolic blood pressure, mean arterial pressure and central venous pressure. Lactate is used as a proxy for microcirculatory status. Over the years several other measurements have been suggested to improve insight in the hemodynamics of a certain patient or a group of patients. Skin temperature, capillary refill, mottling score and urinary output are used for hemodynamic assessment of the peripheral circulation and tissue perfusion. Most of these parameters have not been evaluated in a large prospective study and especially a combination of all these parameters has not directly been correlated to cardiac output.

More knowledge on the predictive value of all hemodynamic parameters in estimating cardiac output could assist physicians in earlier detection of impaired hemodynamics without the need for invasive or advanced methods. In this study the investigators aim to evaluate all hemodynamic parameters in a large unselected population of critically ill patients and to correlate them to cardiac output.

Purpose:

The purpose of this study is to create an infrastructure for a registry flexible to incorporate temporarily added specific research questions on the outcome of critically ill patients.

详细描述

Registry procedures:

Eligible patients will be included within 24 hours after their arrival on the Intensive Care Unit. After inclusion all study parameters will be obtained once through physical examination combined with transthoracic echocardiography. Mortality will be assessed at 90 days after admission. In addition, mortality follow-up will be cut-off at 7 and 30 days after admission.

Monitoring:

Monitoring will be performed by independent researchers of the department of anaesthesiology of the UMCG. Audits are planned to take place once a year.

Quality assurance plan:

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Emergency admission
  • Expected stay > 24 hours

排除标准

  • Age < 18 years
  • Planned admission (either after surgery or for other reasons)
  • Withdrawn or unable to obtain informed consent
  • Continuous resuscitation efforts or mechanical circulatory support

结局指标

主要结局

The association of a single or combination of clinical examination findings with cardiac index measured with transthoracic ultrasonography

时间窗: Immediately

Primary outcome of the basic study, answering our diagnostic research question We calculated cardiac index, which was derived from cardiac output. Cardiac output has been measured with the cardiac probe M3S of M4S with default cardiac imaging setting of the General Electric Vivid-S6 mobile ultrasound machine. Two views were obtained: the parasternal long axis (PLAX) and the apical five chamber view (AP5CH). The PLAX was used as the primary view to measure the left ventricular outflow tract (LVOT) diameter. The AP5CH view was used to measure the velocity time integral (VTI) using the pulse wave Doppler signal in the LVOT. Cardiac output was calculated on the ultrasound machine according to the formula: Cardiac output (L/min)=heart rate ∙VTI∙π∙(1/2∙LVOT)\^2 Clinical examination findings have been collected during a one-time physical examination, which is further specified at the study description section.

The association of all measured clinical examination findings, biochemical values and hemodynamic variables measured with transthoracic echocardiography with 90-day mortality

时间窗: 90 days

Primary outcome of the basic study, answering our prognostic research question. Clinical examination findings, as well are specified at the study description section. Biochemical values are serum lactate, creatinine and hemoglobine (see study description). Hemodynamic variables are obtained from advanced patient monitoring devices, such as invasive central venous or arterial blood pressures, echocardiographic measurements, etc. Follow-up on all-cause mortality will be obtained from the municipal personal records database. Analysis of mortality will be performed using time-to-event data (patients were censored at 90-days of follow-up).

次要结局

  • The association of clinical examination, biochemical and haemodynamic variables that are not visible to caregivers with 90-day mortality(90 days)
  • The association of clinical examination, biochemical and haemodynamic variables and 7- and 30-day mortality(30 days)
  • The association and diagnostic test accuracy of a single or combination of clinical examination findings with cardiac index in clinically different patient subgroups(Immediately)
  • The diagnostic test accuracy of a single or a combination of clinical examination findings to diagnose a low, normal and high cardiac index measured with transthoracic echocardiography(Immediately)
  • The association of clinical examination, biochemical and haemodynamic variables with 90-day mortality in clinically different patient subgroups(90 days)

研究者

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

I.C.C. van der Horst

Associate professor

University Medical Center Groningen

研究点 (1)

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