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

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.

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Key information

Conditions

Supratentorial Brain Tumor Hyponatremia Metabolic Diseases Nutritional and Metabolic Diseases Water-Electrolyte Imbalance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients undergoing surgical management for supratentorial/suprasellar tumors.

Exclusion criteria

Glasgow Coma Score (GCS) <4.

Treatment and study plan

Serum Sodium

Diagnostic Test

Measurement of serum sodium.

Primary outcomes

Mortality

Time frame: 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 outcomes

Duration of hospital stay

Time frame: 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.

Time frame: 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

Time frame: 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

Time frame: 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.

Sponsors and collaborators

Lead sponsor

National Institute of Mental Health and Neuro Sciences, India

Other

Registry information

Important dates

Study start: 2013
Primary completion: 2014
Study completion: 2014
First posted: Jun 26, 2018
Registry last updated: Jun 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed