HyponatremiaNCT01879774
Characterisation of Neuropsychological and Motoric Performance in Patients With Hyponatremia
A study testing Neuropsychological and motoric tests in people with Hyponatremia, run by University of Cologne at 3 sites in 3 countries.
Trial summary
The aim of this epidemiological study is to characterize the neuropsychological and motoric performance in patients with hyponatremia. Newer studies revealed an association between mild hyponatremia and unstable walking, frequency of falls and risk of a fracture, questioning the paradigm of an "asymptomatic"… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyponatremia
- What is being tested?
- Neuropsychological and motoric tests
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 189 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Jun 2012to Apr 2022
- Phase
- Interventional
- 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
Who may be able to join
- Men and women 18 years of age or older
- Hyponatremia with serum sodium < 130 mmol/l
- Men and women with normal serum sodium > 130 mmol/l (control group)
Who cannot join
- traumatic cerebral injury, hemorrhagic and ischemic insult as cause of hyponatremia
- professional or private relationship between subject and the investigators, or dependance on the investigators
- Placement in an institution based on official orders
- Patients who are unable to give informed consent
- Patients with contraindication for MRI investigation
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
Italy1 site
Dipartimento di Scienze Biomediche, Sperimentali e Cliniche Mario Serio
Florence, 50139
About this study
The aim of this epidemiological study is to characterize the neuropsychological and motoric performance in patients with hyponatremia. Newer studies revealed an association between mild hyponatremia and unstable walking, frequency of falls and risk of a fracture, questioning the paradigm of an "asymptomatic" hyponatremia. Until now, there is no known detailed investigation and characterisation of the cognitive and motoric performance or limitation by this disorder. Therefore this study will investigate patients with hyponatremia on the basis of neuropsychological and neurological tests.
Read the detailed description
Hyponatremia is the most common electrolyte disorder in outpatients and hospitalized patients. The prevalence of hospital-associated hyponatremia is estimated to be up to 40%. Especially mild to moderate hyponatremia (125-136 mmo/l) without apparent symptoms has seldomly been accurately assessed but rather seen as clinically irrelevant. Cognitive limitations, unstable gait and motoric disorders as well as depressive conditions were described in smaller studies and single case reports.
In terms of the question, if a therapeutic influence is also reasonable in slight symptomatic hyponatremia it is necessary to establish an accurate phenotyping of patients with hyponatremia, which quantifies the individual cognitive, motoric and psychological qualities.
Patients with hyponatremia will be examined on the basis of standardized neuropsychological and neurological tests. Following questions are to be answered with this study:
- Which cognitive, motoric and psychological functions are impaired due to hyponatremia?
- Is there a correlation between the extend of hyponatremia and the different test results?
- Is there an intraindividual difference in test results during hyponatremia and normal sodium concentrations?
In addition to clinical testing, functional magnetic resonance imaging (fMRI) will be performed before and after therapy in up to 40 patients with hyponatremia. Functional magnetic resonance imaging (fMRI) is an imaging procedure in which local changes in cerebral oxygen concentration can be used to draw conclusions about brain activity. In connection with the current research project, an initial contribution is to be made in order to close the existing knowledge gap as to whether a functionally-image-morphologically tangible change in cerebral activity can also be depicted non-invasively by means of fMRI during hyponatremia or after its compensation. Another component of cerebral evaluation in this context is volumetry in fMRI.
- Conditions
- Hyponatremia
- Being tested
- Neuropsychological and motoric tests
- Keywords
- Hyponatremia
- Medical subject headings
- Hyponatremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuropsychological and motoric testsOther
- Neuropsychological tests
- Mini Mental Status Test
- Dem-Tect
- Rey-Osterrieth Complex Figure Test
- Trailmaking Test
- Beck Depression Inventory
- d2-R (optional)
- Motoric tests
- modified UPDRS (Unified Parkinson Disease Rating Scale) Part III
- Timed-up-and-go Test
- Halstead Fingertapping Test
- AIMS (Abnormal involuntary movement scale)
- EEG (only in patients with hyponatremia)
- MRI (only in patients with hyponatremia)
| Study group | Role | What they receive |
|---|---|---|
| Patients with hyponatremia | Other | Neuropsychological and motoric tests are conducted in patients with hyponatremia. Receives: Other: Neuropsychological and motoric tests |
| Patients with normal serum sodium | Other | Neuropsychological and motoric tests are conducted in patients with normal serum sodium. Receives: Other: Neuropsychological and motoric tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Performance in individual tests
Measured: Change in individual tests at Baseline and at least 48 hours after first assessment
Secondary outcomes (1)
Assessment of cerebral basal activity in fMRI during hyponatremia and after its compensation
Measured: Change in fMRI from baseline and at least 48 hours after first assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2013 (estimated)
- Study startJun 2012
- Primary completionJan 2022
- Study completionApr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyponatremiaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 189 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Volker Burst, University of Cologne
- Investigators
- Volker Burst, MD, Principal investigator, University Hospital of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01879774
- Sponsor's protocol ID
- 002
- Status last verified
- May 2022
- First submitted
- 23 Apr 2013
- Last updated
- 25 May 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterisation of Neuropsychological and Motoric Performance in Patients With Hyponatremia
- ClinicalTrials.gov ID
- NCT01879774
- Acronym / sponsor ID
- 002
- Conditions
- Hyponatremia
- Keywords
- Hyponatremia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 189 participants (actual)
- Lead sponsor
- University of CologneUniversity, hospital or other
- Study start
- Jun 2012 (actual)
- Primary completion
- Jan 2022 (actual)
- Study completion
- Apr 2022 (actual)
- First posted
- 18 Jun 2013 (estimated)
- 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.
The aim of this epidemiological study is to characterize the neuropsychological and motoric performance in patients with hyponatremia. Newer studies revealed an association between mild hyponatremia and unstable walking, frequency of falls and risk of a fracture, questioning the paradigm of an "asymptomatic" hyponatremia. Until now, there is no known detailed investigation and characterisation of the cognitive and motoric performance or limitation by this disorder. Therefore this study will investigate patients with hyponatremia on the basis of neuropsychological and neurological tests.
Detailed description
Hyponatremia is the most common electrolyte disorder in outpatients and hospitalized patients. The prevalence of hospital-associated hyponatremia is estimated to be up to 40%. Especially mild to moderate hyponatremia (125-136 mmo/l) without apparent symptoms has seldomly been accurately assessed but rather seen as clinically irrelevant. Cognitive limitations, unstable gait and motoric disorders as well as depressive conditions were described in smaller studies and single case reports.
In terms of the question, if a therapeutic influence is also reasonable in slight symptomatic hyponatremia it is necessary to establish an accurate phenotyping of patients with hyponatremia, which quantifies the individual cognitive, motoric and psychological qualities.
Patients with hyponatremia will be examined on the basis of standardized neuropsychological and neurological tests. Following questions are to be answered with this study:
- Which cognitive, motoric and psychological functions are impaired due to hyponatremia?
- Is there a correlation between the extend of hyponatremia and the different test results?
- Is there an intraindividual difference in test results during hyponatremia and normal sodium concentrations?
In addition to clinical testing, functional magnetic resonance imaging (fMRI) will be performed before and after therapy in up to 40 patients with hyponatremia. Functional magnetic resonance imaging (fMRI) is an imaging procedure in which local changes in cerebral oxygen concentration can be used to draw conclusions about brain activity. In connection with the current research project, an initial contribution is to be made in order to close the existing knowledge gap as to whether a functionally-image-morphologically tangible change in cerebral activity can also be depicted non-invasively by means of fMRI during hyponatremia or after its compensation. Another component of cerebral evaluation in this context is volumetry in fMRI.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with hyponatremia | Other | Other: Neuropsychological and motoric testsNeuropsychological and motoric tests are conducted in patients with hyponatremia. |
| Patients with normal serum sodium | Other | Other: Neuropsychological and motoric testsNeuropsychological and motoric tests are conducted in patients with normal serum sodium. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men and women 18 years of age or older
- Hyponatremia with serum sodium < 130 mmol/l
- Men and women with normal serum sodium > 130 mmol/l (control group)
Key exclusion criteria (5 listed)
- traumatic cerebral injury, hemorrhagic and ischemic insult as cause of hyponatremia
- professional or private relationship between subject and the investigators, or dependance on the investigators
- Placement in an institution based on official orders
- Patients who are unable to give informed consent
- Patients with contraindication for MRI investigation
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 |
|---|---|---|
| Neuropsychological and motoric tests1. Neuropsychological tests * Mini Mental Status Test * Dem-Tect * Rey-Osterrieth Complex Figure Test * Trailmaking Test * Beck Depression Inventory * d2-R (optional) 2. Motoric tests * modified UPDRS (Unified Parkinson Disease Rating Scale) Part III * Timed-up-and-go Test * Halstead Fingertapping Test * AIMS (Abnormal involuntary movement scale) 3. EEG (only in patients with hyponatremia) 4. MRI (only in patients with hyponatremia) | Other | Patients with hyponatremia, Patients with normal serum sodium |
Primary outcome
Assessment of Performance in individual tests
Time frame: Change in individual tests at Baseline and at least 48 hours after first assessment
1 secondary outcome
Assessment of cerebral basal activity in fMRI during hyponatremia and after its compensation
Time frame: Change in fMRI from baseline and at least 48 hours after first assessment
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 25 May 2022.
Related trials for Hyponatremia
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International Multi-center Retrospective Study of Patients With Serum Sodium ≤110 mmol/L to Determine the Relationship Between Osmotic Demyelination Syndrome (ODS) and Rapid Correction of Hyponatremia
Hyponatremia Symptomatic, Osmotic Demyelination Syndrome
Active, not recruitingObservational study
Samsca Post-marketing General Drug Use-results Survey in Patients With Hyponatremia in SIADH
Antidiuretic Hormone, Inappropriate Secretion
Recruiting
Urea for Treatment of Hyponatremia in Patients With SIAD Unresponsive to Fluid Restriction
SIAD - Syndrome of Inappropriate Antidiuresis
Active, not recruitingObservational study
Hyponatremia - Complications, Prognosis, Epidemiology in Finnish Tertiary Care
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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.
Volker Burst, MD principal investigator
University Hospital of Cologne
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuropsychological and motoric tests in people with Hyponatremia, run by University of Cologne at 3 sites in 3 countries.
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 3 inclusion and 5 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 25 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany, Italy, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Assessment of Performance in individual tests (time frame: Change in individual tests at Baseline and at least 48 hours after first assessment). 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 25 May 2022.