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

NCT03570203 | Completed

• 1 other identifier: Sl.No., Clinical Neurosciences
• Study Type: observational
• Target: 173
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Supratentorial Brain Tumor

Keywords

Hyponatremia; Dysnatremia; Neurosurgery; Neurointensive Care

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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.

• 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.

• 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.

• 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.

Study Arms (2)

Retrospective Cohort

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

Diagnostic Test: Serum Sodium

Prospective Cohort

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

Diagnostic Test: Serum Sodium

Interventions

Serum Sodium DIAGNOSTIC_TEST

Measurement of serum sodium.

Prospective Cohort; Retrospective Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to NIMHANS for surgical management of Supratentorial/Suprasellar tumor management with GCS \> 3 at recruitment (for prospective cohort) or admission (for retrospective cohort).

You may qualify if:

• Patients undergoing surgical management for supratentorial/suprasellar tumors.

You may not qualify if:

• Glasgow Coma Score (GCS) \<4.

Sponsors & Collaborators

• National Institute of Mental Health and Neuro Sciences, India: lead

MeSH Terms

Conditions

Hyponatremia

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 14, 2018
• First Posted: June 26, 2018
• Study Start: December 15, 2013
• Primary Completion: April 30, 2014
• Study Completion: April 30, 2014
• Last Updated: June 26, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share