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

Supratentorial Brain Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03570203
• Other study ID #: Sl.No., Clinical Neurosciences
• Status: Completed
• Start date: December 15, 2013
• Est. completion date: April 30, 2014

Study information

• Verified date: June 2018
• Source: National Institute of Mental Health and Neuro Sciences, India
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 173
• Est. completion date: April 30, 2014
• Est. primary completion date: April 30, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Patients undergoing surgical management for supratentorial/suprasellar tumors.

Exclusion Criteria:

Glasgow Coma Score (GCS) <4.

Related Conditions & MeSH terms

• Supratentorial Brain Tumor
• Supratentorial Neoplasms

Intervention

Diagnostic Test:
• Serum Sodium
Measurement of serum sodium.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Mental Health and Neuro Sciences, India

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	To observe relationship between hyponatremia in supratentorial tumor patients and in-hospital 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.
Secondary	Duration of hospital stay	To observe relationship between hyponatremia in supratentorial tumor patients and 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.
Secondary	Rate of admission in intensive care unit.	To observe relationship between hyponatremia in supratentorial tumor patients and 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.
Secondary	Neurological deficits	To observe relationship between hyponatremia in supratentorial tumor patients and incidence of 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.
Secondary	Seizures	To observe relationship between hyponatremia in supratentorial tumor patients and incidence of 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.