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临床试验/NCT01930669
NCT01930669已完成不适用

Transplanted-like Heart in Critical Ill Patients

ASST Fatebenefratelli Sacco4 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2013年8月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
150
试验地点
4
主要终点
Incidence of autonomic nervous system dysfunction in critical ill patients

研究概览

简要总结

The purpose of this study is to measure the dysfunction of the autonomic nervous system in modulating the heart rate variability and baroreflex control in critically ill.

详细描述

Autonomic nervous system (ANS) is able to change both heart beat-to-beat interval and peripheral muscle vascular tone in response to different stimuli. Unfortunately the direct measure of the sympathetic and vagal activity appears not feasible in a clinical setting. ANS modulation is studied non-invasively by means of heart rate variability (HRV) and baroreflex sensitivity. Decreased HRV has been found in critical ill patients with multiple organ dysfunction syndrome (MODS) and sepsis, thus it has been supposed being a sign of autonomic dysfunction. Frequently, in mechanically ventilated critical ill patients the HRV does not show any oscillatory pattern, as well as it appears in the early months after heart transplantation. Under these circumstances the heart seems to lack the neuro-modulatory control by ANS and it seems to respond exclusively to the preload and afterload laws. This could have implications for outcome because autonomic dysfunction is associated with increasing severity of illness and mortality. Since the ANS modulation is a dynamic process that implies a central integration of a complex variety of afferent stimuli (from carotid sinus, cardiopulmonary receptors, pain,...) and efferences through sympathetic and vagal branches, up to the present it is unclear if in critically ill a reduced HRV at rest reflects a state of low requirement of ANS modulation or truly a failure of the ANS. To provide new insights into this important topic we study the changes of ANS modulation in response to a orthostatic sympathetic stimulus daily from the day of ICU admission until day 28, or the day of discharge from ICU if it occurs before the day 28.

Measurements. Beat-to-beat intervals are computed detecting the QRS complex on the electrocardiogram and locating the R-apex using parabolic interpolation. The maximum arterial pressure within each R-to-R interval is taken as systolic arterial pressure (SAP). Sequences of 300 values are randomly selected inside each experimental condition. The power spectrum is estimated according to a univariate parametric approach fitting the series to an autoregressive model. Autoregressive spectral density is factorized into components each of them characterized by a central frequency. A spectral component is labeled as low frequency (LF) if its central frequency is between 0.04 and 0.15 Hz, while it is classified as high frequency (HF) if its central frequency is between 0.15 and 0.4 Hz. The HF power of R-to-R series is utilized as a marker of vagal modulation directed to the heart , while the LF power of SAP series is utilized as a marker of sympathetic modulation directed to vessels. The ratio of the LF power to the HF power assessed from R-to-R series is taken as an indicator sympatho-vagal balance directed to the heart. Baroreflex control in the low frequencies is computed as the square root of the ratio of LF(RR) to LF(SAP). In the same way baroreflex control in the high frequencies is defined as the square root of the ratio of HF(RR) to HF(SAP).

The experimental condition is a sequence of three time point each lasting 10 min: (i) rest, with patient in supine position at zero degree; (ii) modified tilt; (iii) recovery, with the patient supine.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients admitted in ICU with
  • age between 18 and 75 years
  • expected length of stay in ICU >24 hours
  • sinus rhythm on ECG
  • ectopic heart beats <5% of all heart beats
  • no contraindications of any kind to head-up 60 degrees position

排除标准

  • age <18 and >75 years
  • elective postoperative patients
  • non sinusal rhythm of ECG
  • ectopic heart beats >5% of all heart beats
  • spinal or head injury
  • suspected or documented intracranial hypertension
  • contraindications of any kind to head up 60 degrees position

研究组 & 干预措施

All patients

Other

To measure the autonomic nervous system activity elicited by a gravitational sympathetic stimulus in critically ill

干预措施: Gravitational sympathetic stimulus (Other)

结局指标

主要结局

Incidence of autonomic nervous system dysfunction in critical ill patients

时间窗: from day 1 to day 28

failure to change significantly HRV and baroreflex variables in response to MTILT.

次要结局

  • to measure the occurrence of ANS failure in subgroups(from day 1 to day 28)
  • Length of stay in ICU and in Hospital(8 months)
  • mortality(8 months)
  • days free from mechanical ventilation(28 days)

研究者

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

Riccardo Colombo

MD

ASST Fatebenefratelli Sacco

研究点 (4)

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