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

Completed

• Conditions: Supratentorial Brain Tumor
• Interventions: Diagnostic Test: Serum Sodium

• Registration Number: NCT03570203
• Lead Sponsor: National Institute of Mental Health and Neuro Sciences, India

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2013-12-15
• Primary Completion: 2014-04-30
• Study Completion: 2014-04-30
• Status Verified: 2018-06
• Study First Submitted: 2018-06-14
• Study First Submitted QC: 2018-06-25
• Last Update Submitted: 2018-06-25
• Study First Posted: 2018-06-26
• Last Update Posted: 2018-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 173

Inclusion Criteria

Patients undergoing surgical management for supratentorial/suprasellar tumors.

Exclusion Criteria

Glasgow Coma Score (GCS) <4.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Prospective Cohort	Serum Sodium	Supratentorial/Suprasellar brain tumor patients with Glasgow Coma Score \> 3 at time of recruitment.
Retrospective Cohort	Serum Sodium	Supratentorial/Suprasellar brain tumor patients with Glasgow Coma Score \> 3 at time of admission.

Primary Outcome Measures

Name	Time	Method
Mortality	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.

Secondary Outcome Measures

Name	Time	Method
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.	To observe relationship between hyponatremia in supratentorial tumor patients and duration of hospital stay.
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.	To observe relationship between hyponatremia in supratentorial tumor patients and rate of admission in intensive care unit.
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.	To observe relationship between hyponatremia in supratentorial tumor patients and incidence of neurological deficits.
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.	To observe relationship between hyponatremia in supratentorial tumor patients and incidence of seizures.