跳至主要内容
临床试验/CTRI/2024/11/077063
CTRI/2024/11/077063招募中不适用

Role of Fluid Response Assessment In New Onset Hyponatremia and correlation with sodium correction in critically ill neurological patients- A Prospective Observational Study

National Institute of Mental Health and Neurosciences1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2024年11月30日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
150
试验地点
1
主要终点
Change in 24 hour sodium

研究概览

简要总结

Hyponatremia is the most common electrolyte disorder in patients admitted to the neuro-intensive care unit (NICU). The incidence of hyponatremia is 38-50% in NICUs and can significantly affect patient outcomes. The etiology and treatment strategies for correcting hyponatremia are often related to the patient’s volume status. The intensivists often judge the patient’s volume status by clinical assessment and the information from the inferior vena cava (IVC) diameter measurement. However, with this, it may be difficult to differentiate between hypovolemia and euvolemia. Use of dynamic measures such as stroke volume variation (SVV) or pulse pressure variation by pulse contour analysis method are also employed to understand the volume status, however, the cardio-pulmonary interactions pose a significant limitation to the interpretation of underlying volume status . These methods are often misleading and thus addressing the underlying volume status even more challenging. The assessment of fluid responsiveness by a fluid challenge (FC) or the passive leg raise (PLR)-induced stroke volume (SV) change, can also be monitored with non-invasive cardiac output (CO) monitor (NICOM). The operating principle of NICOM is the bioreactance to the applied current to the thorax, which is devoid of heart-lung interaction and can thus be well utilised in spontaneously breathing patients. This modality has been observed as a reliable indicator of volume status, including in patients with sepsis, and found to be safe in guiding fluid administration and may improve outcomes . However, the application of the assessment of fluid responsiveness using the NICOM has not been studied in patients with hyponatremia. This study aims to assess the volume status using PLR response in patients admitted to NICU and who develops new-onset sodium abnormalities. The findings of this study shall help to better understand the underlying mechanisms and guide appropriate management strategies.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • 未提供

排除标准

  • Pre-existing sodium abnormalities/ on treatment before admission.
  • Patients with inotropes or vasopressor
  • Patients with end-stage renal disease or on dialysis.
  • Patients with chronic liver disease.
  • Patients with congestive heart failure, and cardiac pathology.
  • Patients with raised ICP.

结局指标

主要结局

Change in 24 hour sodium

时间窗: 1. 24 hour | 2. 48 hour | 3. 72 hour | 4. 96 hour

次要结局

未报告次要终点

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Rohini M Surve

National Institute of Mental Health and Neurosciences, Bengaluru

研究点 (1)

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