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临床试验/NCT03570203
NCT03570203已完成不适用

Spectrum of Serum Sodium Disturbances in Patients With Non-sellar/Suprasellar Supratentorial Tumors

National Institute of Mental Health and Neuro Sciences, India0 个研究点目标入组 173 人开始时间: 2013年12月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
173
主要终点
Mortality

研究概览

简要总结

This study was designed to quantify the incidence of hyponatremia in patients of supratentorial/supra-sellar lesions and observe their effect on neurological morbidity and mortality.

详细描述

Disorders of sodium and water balance are one of the commonly encountered problems while managing patients with neurological diseases. Managing such problems are challenging because the pathophysiology behind these disorders are complex and poorly understood and treatment of the injured brain itself can contribute to, and complicate the diagnosis of sodium disorders. Serum sodium disturbance can manifest as hypernatremia or hyponatremia. Hypernatremia usually occurs in the diabetes insipidus syndrome, whereas hyponatremia develops as a syndrome of inappropriate secretion of antidiuretic hormone (SIADH) or cerebral salt-wasting syndrome (CSWS).

Because of the cerebral effects of hyponatremia, neurosurgical patients are at increased risk of complications including severe cerebral edema, mental status changes, seizures, vasospasm, and death.

Though the problem of hyponatremia has been addressed in patients with different brain pathologies, this has not been studied in patients with non-sellar/suprasellar supratentorial tumors. This study was envisioned to quantify the incidence and magnitude of hyponatremia in this patient population and their subsequent neurological morbidity and mortality.

研究设计

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

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

  • Patients undergoing surgical management for supratentorial/suprasellar tumors.

排除标准

  • Glasgow Coma Score (GCS) <4.

结局指标

主要结局

Mortality

时间窗: From date of admission to hospital to date of Discharge from hospital or Death in hospital, whichever comes first, assessed up to 2 years from date of admission.

To observe relationship between hyponatremia in supratentorial tumor patients and in-hospital mortality.

次要结局

  • Duration of hospital stay(From date of admission to hospital to date of Discharge from hospital or Death in hospital, whichever comes first, assessed up to 2 years from date of admission.)
  • Rate of admission in intensive care unit.(From date of admission to hospital to date of Discharge from hospital or Death in hospital, whichever comes first, assessed up to 2 years from date of admission.)
  • Neurological deficits(From date of admission to hospital to date of Discharge from hospital or Death in hospital, whichever comes first, assessed up to 2 years from date of admission.)
  • Seizures(From date of admission to hospital to date of Discharge from hospital or Death in hospital, whichever comes first, assessed up to 2 years from date of admission.)

研究者

发起方
National Institute of Mental Health and Neuro Sciences, India
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dhritiman Chakrabarti

Assistant Professor

National Institute of Mental Health and Neuro Sciences, India

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