Supratentorial Brain TumorNCT03570203
Spectrum of Serum Sodium Disturbances in Patients With Non-sellar/Suprasellar Supratentorial Tumors
An observational study of Supratentorial Brain Tumor, run by National Institute of Mental Health and Neuro Sciences, India.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Supratentorial Brain Tumor
- What is being tested?
- Serum Sodium
- How many people
- 173 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2013to 30 Apr 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- Patients undergoing surgical management for supratentorial/suprasellar tumors.
Who cannot join
- Glasgow Coma Score (GCS) <4.
About this study
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.
Read the 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.
- Conditions
- Supratentorial Brain Tumor
- Being tested
- Serum Sodium
- Keywords
- Hyponatremia, Dysnatremia, Neurosurgery, Neurointensive Care
- Medical subject headings
- Hyponatremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum SodiumDiagnostic test
Measurement of serum sodium.
| Study group | Role | What they receive |
|---|---|---|
| Retrospective Cohort | Supratentorial/Suprasellar brain tumor patients with Glasgow Coma Score > 3 at time of admission. Receives: Diagnostic Test: Serum Sodium | |
| Prospective Cohort | Supratentorial/Suprasellar brain tumor patients with Glasgow Coma Score > 3 at time of recruitment. Receives: Diagnostic Test: Serum Sodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
To observe relationship between hyponatremia in supratentorial tumor patients and in-hospital mortality.
Measured: 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
To observe relationship between hyponatremia in supratentorial tumor patients and duration of hospital stay.
Measured: 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.
To observe relationship between hyponatremia in supratentorial tumor patients and rate of admission in intensive care unit.
Measured: 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
To observe relationship between hyponatremia in supratentorial tumor patients and incidence of neurological deficits.
Measured: 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
To observe relationship between hyponatremia in supratentorial tumor patients and incidence of seizures.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2018
- Study start15 Dec 2013
- Primary completion30 Apr 2014
- Study completion30 Apr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Supratentorial Brain TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 173 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health and Neuro Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dhritiman Chakrabarti, National Institute of Mental Health and Neuro Sciences, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03570203
- Sponsor's protocol ID
- Sl.No., Clinical Neurosciences
- Status last verified
- Jun 2018
- First submitted
- 14 Jun 2018
- Last updated
- 26 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spectrum of Serum Sodium Disturbances in Patients With Non-sellar/Suprasellar Supratentorial Tumors
- ClinicalTrials.gov ID
- NCT03570203
- Acronym / sponsor ID
- Sl.No., Clinical Neurosciences
- Conditions
- Supratentorial Brain Tumor
- Keywords
- Hyponatremia, Dysnatremia, Neurosurgery, Neurointensive Care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 173 participants (actual)
- Lead sponsor
- National Institute of Mental Health and Neuro Sciences, IndiaUniversity, hospital or other
- Study start
- 15 Dec 2013 (actual)
- Primary completion
- 30 Apr 2014 (actual)
- Study completion
- 30 Apr 2014 (actual)
- First posted
- 26 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrospective Cohort | – | Diagnostic Test: Serum SodiumSupratentorial/Suprasellar brain tumor patients with Glasgow Coma Score > 3 at time of admission. |
| Prospective Cohort | – | Diagnostic Test: Serum SodiumSupratentorial/Suprasellar brain tumor patients with Glasgow Coma Score > 3 at time of recruitment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (1 listed)
- Patients undergoing surgical management for supratentorial/suprasellar tumors.
Key exclusion criteria (1 listed)
- Glasgow Coma Score (GCS) <4.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Serum SodiumMeasurement of serum sodium. | Diagnostic test | Prospective Cohort, Retrospective Cohort |
Primary outcome
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.
4 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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Supratentorial Brain Tumor, run by National Institute of Mental Health and Neuro Sciences, India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2018.