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

NCT ID: NCT03570203

Last Updated: 2018-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

173 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-12-15

Study Completion Date

2014-04-30

Brief Summary

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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

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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.

Conditions

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Supratentorial Brain Tumor

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Retrospective Cohort

Supratentorial/Suprasellar brain tumor patients with Glasgow Coma Score \> 3 at time of admission.

Serum Sodium

Intervention Type DIAGNOSTIC_TEST

Measurement of serum sodium.

Prospective Cohort

Supratentorial/Suprasellar brain tumor patients with Glasgow Coma Score \> 3 at time of recruitment.

Serum Sodium

Intervention Type DIAGNOSTIC_TEST

Measurement of serum sodium.

Interventions

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Serum Sodium

Measurement of serum sodium.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

Patients undergoing surgical management for supratentorial/suprasellar tumors.

Exclusion Criteria

Glasgow Coma Score (GCS) \<4.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health and Neuro Sciences, India

OTHER

Sponsor Role lead

Responsible Party

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Dhritiman Chakrabarti

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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Sl.No., Clinical Neurosciences

Identifier Type: -

Identifier Source: org_study_id

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