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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03570203
Enrollment
173
Registered
2018-06-26
Start date
2013-12-15
Completion date
2014-04-30
Last updated
2018-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Supratentorial Brain Tumor

Keywords

Hyponatremia, Dysnatremia, Neurosurgery, Neurointensive Care

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.

Interventions

DIAGNOSTIC_TESTSerum Sodium

Measurement of serum sodium.

Sponsors

National Institute of Mental Health and Neuro Sciences, India
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Patients undergoing surgical management for supratentorial/suprasellar tumors.

Exclusion criteria

Glasgow Coma Score (GCS) \<4.

Design outcomes

Primary

MeasureTime frameDescription
MortalityFrom 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

MeasureTime frameDescription
Duration of hospital stayFrom 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 deficitsFrom 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.
SeizuresFrom 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026