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

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StatusCompleted
Sponsors
National Institute of Mental Health and Neuro Sciences, India

Keywords

Abstract

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.

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.

Dates

Last Verified: 05/31/2018
First Submitted: 06/13/2018
Estimated Enrollment Submitted: 06/24/2018
First Posted: 06/25/2018
Last Update Submitted: 06/24/2018
Last Update Posted: 06/25/2018
Actual Study Start Date: 12/14/2013
Estimated Primary Completion Date: 04/29/2014
Estimated Study Completion Date: 04/29/2014

Condition or disease

Supratentorial Brain Tumor

Intervention/treatment

Diagnostic Test: Serum Sodium

Phase

-

Arm Groups

ArmIntervention/treatment
Retrospective Cohort
Supratentorial/Suprasellar brain tumor patients with Glasgow Coma Score > 3 at time of admission.
Prospective Cohort
Supratentorial/Suprasellar brain tumor patients with Glasgow Coma Score > 3 at time of recruitment.

Eligibility Criteria

Ages Eligible for Study 18 Years To 18 Years
Sexes Eligible for StudyAll
Sampling methodNon-Probability Sample
Accepts Healthy VolunteersYes
Criteria

Inclusion Criteria:

Patients undergoing surgical management for supratentorial/suprasellar tumors.

Exclusion Criteria:

Glasgow Coma Score (GCS) <4.

Outcome

Primary Outcome Measures

1. 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

1. 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.

2. 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.

3. 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.

4. 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.

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