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临床试验/CTRI/2024/07/070944
CTRI/2024/07/070944尚未招募不适用

Transcranial Doppler Derived Cerebral Hemodynamic Phenotypes in Children With sepsis: A Single Centre Prospective Cohort Study

Amit Kumar1 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2024年8月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
92
试验地点
1
主要终点
To categorize the cerebral flow velocity phenotypes derived from transcranial doppler in children with sepsis.

研究概览

简要总结

We propose to study the different phenotypes of transcranial doppler (TCD) derived cerebral blood flow velocity parameters in Indian children with sepsis or septic shock and its association with the clinical outcome in these children.

Dysregulated, self-sustaining, and uncontrolled intravascular inflammation during sepsis lead to rapidly progressing end organ dysfunction culminating in septic shock and multi organ dysfunction. Research in children revealed loss of hemodynamic coherence, i.e., microcirculatory alterations despite normal systemic haemodynamics. Cerebral microcirculation is gradually compromised during sepsis, with significant reductions in the function of capillaries and blood perfusion in small vessels.To develop efficacious adjunctive therapeutic approaches that improve outcomes in paediatric sepsis, mechanisms of neurological injury must be determined. Transcranial Doppler Ultrasound (TCD) is a portable, non-invasive method to assess the cerebral blood flow velocities (CBFVs) and haemodynamics in the major cerebral vessels. The measurement of CBF velocity (CBFV) with TCD can be considered a surrogate of CBF, if it is assumed that the diameter of the vessel remains constant. Therefore, the changes in CBFV detected by TCD could represent the hemodynamic changes mediated by microcirculation. TCD derived CBFVs and morphologic waveforms are determined by the mean arterial pressure, the tone and patency of the systemic and cerebral vessels, and the intracranial and central venous pressures. Alterations to any of these factors results in distinct changes to measured TCD parameters and waveform morphology. Thus, TCD is used as a point of care tool to determine specific mechanisms of focal or global cerebral dysfunction in several clinical scenarios. The rationale behind doing this study is to look for different patterns in TCD derived cerebral hemodynamic parameters in children with septic shock in PICU.

This study is to be done in children of 1 – 18 years age group being admitted in PICU with sepsis or septic shock. Cerebral blood flow velocities, pulsatility index and resistive index will be recorded using transcranial doppler ultrasound at predetermined intervals. Different phenotypes of TCD derived cerebral blood flow velocities in children with sepsis or septic shock will be evaluated. Its correlation with the hemodynamic parameters and its association with the clinical outcomes in pediatric septic shock will be studied.

研究设计

研究类型
Observational

入排标准

年龄范围
1.00 Year(s) 至 18.00 Year(s)(—)
性别
All

入选标准

  • All children between 1 yr-18 years of age admitted in Paediatric intensive care unit with a diagnosis of sepsis/septic shock.

排除标准

  • Children less than 1 year of age B.
  • Traumatic brain injury C.
  • CNS malformation D.
  • CNS malignancy E.
  • Children with seizure disorder F.
  • Cerebral palsy G.
  • Global developmental delay H.
  • Sickle cell disease I.
  • Severe acute malnutrition J.
  • Congenital heart disease K.
  • Refusal to participate in the study.

结局指标

主要结局

To categorize the cerebral flow velocity phenotypes derived from transcranial doppler in children with sepsis.

时间窗: TCD measurements will be done at | 1. Within 6 hours of PICU admission | 2. At 12 hours of PICU admission | 3. At 24 hours of PICU admission | 4. At 48 hours of PICU admission

次要结局

  • Secondary objective:(1. To study the correlation between TCD derived CBFV phenotypes with)

研究者

发起方
Amit Kumar
申办方类型
Other [Self funded]
责任方
Principal Investigator
主要研究者

AMIT KUMAR

St Johns medical college bangalore

研究点 (1)

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