HyponatremiaNCT02242604
Characterization of Neuropsychologic and Physical Performance in Geriatric Patients With Hyponatremia.
An observational study of Hyponatremia, run by Volker Burst at 1 site in Germany.
Trial summary
Our purpose is to investigate the improvement of the cognitive, neuropsychologic and physical capabilities using a standardized multidimensional geriatric assessment (MGA) consisting of a battery of validated assays after correction of hyponatremia in patients 70 years or older. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Hyponatremia
- What is being tested?
- Multidimensional Geriatric Assessment (MGA)
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2014to Aug 2017
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: A total of 150 patients with the age of 70 years or above, that are admitted to the Department for Geriatric Medicine of the University of Cologne, that have a serum sodium of below 130 mmol/L on admission, and that have complete datasets that allow for unequivocal determination of the etiologic cause of hyponatremia will be enrolled in this study.
Who may be able to join
- age of 70 years or above
- serum sodium of 130 mmol/L and below
Who cannot join
- patients not capable of giving informed consent
- patients on intensive care unit (ICU)
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department for Geriatric Medicine - University of Cologne
Cologne, 50937
About this study
Official title: Phenotypic Characterization of Neuropsychologic and Physical Performance in Geriatric Patients Suffering From Hyponatremia.
Our purpose is to investigate the improvement of the cognitive, neuropsychologic and physical capabilities using a standardized multidimensional geriatric assessment (MGA) consisting of a battery of validated assays after correction of hyponatremia in patients 70 years or older.
Read the detailed description
With an occurrence of up to 30%, hyponatremia, defined as a serum sodium concentration of less than 135 mmol/L, is the most commonly encountered electrolyte disorder in hospitalized patients today. The highest incidence of hyponatremia is found in the elderly.
Retrospective analyses clearly show an association between hyponatremia and mortality as well as morbidity and this association is not confined only to severely decreased sodium levels. Hyponatremia can be an acute and life-threatening condition, which is usually reflected by severe signs and symptoms, e.g. coma or seizures,but more often it is of chronic nature, and symptoms may be subtle or even apparently absent due to cerebral adaptation processes. Signs and symptoms include, among others, nausea, drowsiness, cognitive impairment, memory deficits, depression, muscle cramps, or gait instability. However, our knowledge of the highly diverse clinical picture of hyponatremia stems from anecdotic reports and experiments that were performed by the investigators on themselves in the 1930ies. Thus, no accurate and thorough description of the symptomatology of hyponatremiain disease has been carried out so far, except maybe for the extreme conditions, i.e. in patients suffering from seizures or coma. This is why especially patients with chronic mild-to-moderate hyponatremia (sometimes defined as a sodium concentration > 125 mmol/L) who may well have subtle or unspecific symptoms are often perceived as being asymptomatic. Recent investigations have demonstrated that such patients have a significantly increased risk for falls and bone fractures and reduced cognitive capacities. Moreover, anecdotic reports have shown that some patients that were believed to suffer from depression or dementia improved markedly after correction of their concomitanthyponatremia. There is also mounting evidence that hyponatremia induces osteoporosis which adds to the risk of bone fractures. Furthermore, in the SALT-trials, the mental component of the SF-12 questionnaire (Short Form-12) improved significantly after hyponatremia had been corrected. Interestingly, the mean sodium concentration prior to treatment was 129 mmol/L indicating mild or moderate hyponatremia. Given the high prevalence of mild-to-moderate hyponatremiain the elderly, unspecific symptoms like mood instability, cognitive deficits or others, thatare often attributed to old age could simply be a consequence of their low sodium level.
To this end, it might well be that by treating hyponatremia the morbidity/mortality in this population could be reduced and quality of life improved. In light of the growing medico-economic challenges we are facing secondary to the steadily increasing life expectancy and the demographic evolution in the western world and the medical problems that come along with this development the influence of successful correction of hyponatremia on mental and physical health should be evaluated. To our knowledge this has not been investigated so far.
The syndrome of inappropriate ADH secretion (SIADH) accounts for more than a third of all cases of hyponatremia and probably is by far the most frequent aetiology of chronic mild to moderate hyponatremia. While newly developed SIADH is often induced by malignancies, pulmonary or cerebral disease in the general population, longstanding chronic hyponatremia in elderly is usually due to idiopathic or drug-associated SIADH. Apart from SIADH, hypovolemia or reduction of the effective arterial blood volume, e.g. in cardiac failure or liver cirrhosis, are common causes of hyponatremia. Although hyponatremia might have an impact on the mental and physical status as well as on the patient's prognosis regardless of the underlying cause, most aetiologies except for SIADH might be confounding factors, since they often induce a "hyponatremia-like" clinical picture by themselves, e.g. hepatic encephalopathy in liver disease etc. Another possible confounder may be hemoglobin. Recent work shows that hyponatremia is associated with anaemia, which is a highly prevalent symptom in elderly patients and an acknowledged risk factor for poor outcome in this population. The underlying pathogenesis of this association is still unknown. Regarding the fact that anaemia and hyponatremia are both risk factors for increased morbidity and mortality in elderly patients that are potentially curable, analysis of influence on the multidimensional geriatric assessment (MGA) before and after correction is challenging. To our knowledge, these possible confounders have not been accounted for in the existing literature. Moreover, no accurate evaluation of the origin of hyponatremia has been reported.
- Conditions
- Hyponatremia
- Being tested
- Multidimensional Geriatric Assessment (MGA)
- Medical subject headings
- Hyponatremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multidimensional Geriatric Assessment (MGA)Other
The MGA contains the following tests:
- Barthel Katz Index (activity of daily living, ADL)
- Mini Mental State Test (MMST)
- DemTec (dementia detection test)
- Clock Test
- Geriatric Depression Scale (GDS)
- Tinetti Test
- TUG (timed up-and-go Test)
- Esslinger Transfer Scale (ETS)
- Handgrip Test
- Mini Nutritional Assessment (MNA)
| Study group | Role | What they receive |
|---|---|---|
| Not treatment | Patients with the age of 70 years or above, that have a serum sodium of below 130 mmol/L on admission. All patients will be routinely evaluated at admission with a standardized multidimensional geriatric assessment (MGA) consisting of a battery of validated assays. Receives: Other: Multidimensional Geriatric Assessment (MGA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the impact of serum sodium concentration on geriatric assessment scores.
The impact of serum sodium concentration on geriatric assessment scores will be evaluated individually for each assessment score in a linear model, independent variables being a) increment of serum sodium [mmol/L] from the time of the first MGA at hospital admission to the time of the second MGA prior to discharge, and b) baseline serum sodium [mmol/L] at the time of the first MGA at hospital admission, the dependent variable being change of assessment score. A subgroup analysis will be done for SIADH patients.
The association between geriatric assessments and serum sodium [mmol/L] will be analysed by correlation analysis at the time of the first and second MGA.
Measured: Day of admission - 14 to 21 days
Secondary outcomes (1)
Influence of anaemia as a confounder.
To test for a possible influence of anaemia as a confounder, similar analyses will carried out using haemoglobin [g/dl] as the independent factor and compared to the above mentioned analyses.
Measured: day of admission - 14 to 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2014 (estimated)
- Study startApr 2014
- Primary completionDec 2016
- Study completionAug 2017
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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Volker Burst
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Volker Burst, University of Cologne
- Investigators
- Volker Burst, MD, Principal investigator, Department II of Internal Medicine, Nephrology - University Hospital of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02242604
- Sponsor's protocol ID
- V1.1
- Other IDs
- DRKS00005776
- Status last verified
- Aug 2019
- First submitted
- 8 Sep 2014
- Last updated
- 9 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phenotypic Characterization of Neuropsychologic and Physical Performance in Geriatric Patients Suffering From Hyponatremia.
- ClinicalTrials.gov ID
- NCT02242604
- Acronym / sponsor ID
- V1.1
- Conditions
- Hyponatremia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Volker BurstUniversity, hospital or other
- Study start
- Apr 2014 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 17 Sep 2014 (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.
Our purpose is to investigate the improvement of the cognitive, neuropsychologic and physical capabilities using a standardized multidimensional geriatric assessment (MGA) consisting of a battery of validated assays after correction of hyponatremia in patients 70 years or older.
Detailed description
With an occurrence of up to 30%, hyponatremia, defined as a serum sodium concentration of less than 135 mmol/L, is the most commonly encountered electrolyte disorder in hospitalized patients today. The highest incidence of hyponatremia is found in the elderly.
Retrospective analyses clearly show an association between hyponatremia and mortality as well as morbidity and this association is not confined only to severely decreased sodium levels. Hyponatremia can be an acute and life-threatening condition, which is usually reflected by severe signs and symptoms, e.g. coma or seizures,but more often it is of chronic nature, and symptoms may be subtle or even apparently absent due to cerebral adaptation processes. Signs and symptoms include, among others, nausea, drowsiness, cognitive impairment, memory deficits, depression, muscle cramps, or gait instability. However, our knowledge of the highly diverse clinical picture of hyponatremia stems from anecdotic reports and experiments that were performed by the investigators on themselves in the 1930ies. Thus, no accurate and thorough description of the symptomatology of hyponatremiain disease has been carried out so far, except maybe for the extreme conditions, i.e. in patients suffering from seizures or coma. This is why especially patients with chronic mild-to-moderate hyponatremia (sometimes defined as a sodium concentration > 125 mmol/L) who may well have subtle or unspecific symptoms are often perceived as being asymptomatic. Recent investigations have demonstrated that such patients have a significantly increased risk for falls and bone fractures and reduced cognitive capacities. Moreover, anecdotic reports have shown that some patients that were believed to suffer from depression or dementia improved markedly after correction of their concomitanthyponatremia. There is also mounting evidence that hyponatremia induces osteoporosis which adds to the risk of bone fractures. Furthermore, in the SALT-trials, the mental component of the SF-12 questionnaire (Short Form-12) improved significantly after hyponatremia had been corrected. Interestingly, the mean sodium concentration prior to treatment was 129 mmol/L indicating mild or moderate hyponatremia. Given the high prevalence of mild-to-moderate hyponatremiain the elderly, unspecific symptoms like mood instability, cognitive deficits or others, thatare often attributed to old age could simply be a consequence of their low sodium level.
To this end, it might well be that by treating hyponatremia the morbidity/mortality in this population could be reduced and quality of life improved. In light of the growing medico-economic challenges we are facing secondary to the steadily increasing life expectancy and the demographic evolution in the western world and the medical problems that come along with this development the influence of successful correction of hyponatremia on mental and physical health should be evaluated. To our knowledge this has not been investigated so far.
The syndrome of inappropriate ADH secretion (SIADH) accounts for more than a third of all cases of hyponatremia and probably is by far the most frequent aetiology of chronic mild to moderate hyponatremia. While newly developed SIADH is often induced by malignancies, pulmonary or cerebral disease in the general population, longstanding chronic hyponatremia in elderly is usually due to idiopathic or drug-associated SIADH. Apart from SIADH, hypovolemia or reduction of the effective arterial blood volume, e.g. in cardiac failure or liver cirrhosis, are common causes of hyponatremia. Although hyponatremia might have an impact on the mental and physical status as well as on the patient's prognosis regardless of the underlying cause, most aetiologies except for SIADH might be confounding factors, since they often induce a "hyponatremia-like" clinical picture by themselves, e.g. hepatic encephalopathy in liver disease etc. Another possible confounder may be hemoglobin. Recent work shows that hyponatremia is associated with anaemia, which is a highly prevalent symptom in elderly patients and an acknowledged risk factor for poor outcome in this population. The underlying pathogenesis of this association is still unknown. Regarding the fact that anaemia and hyponatremia are both risk factors for increased morbidity and mortality in elderly patients that are potentially curable, analysis of influence on the multidimensional geriatric assessment (MGA) before and after correction is challenging. To our knowledge, these possible confounders have not been accounted for in the existing literature. Moreover, no accurate evaluation of the origin of hyponatremia has been reported.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Not treatment | – | Other: Multidimensional Geriatric Assessment (MGA)Patients with the age of 70 years or above, that have a serum sodium of below 130 mmol/L on admission. All patients will be routinely evaluated at admission with a standardized multidimensional geriatric assessment (MGA) consisting of a battery of validated assays. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- A total of 150 patients with the age of 70 years or above, that are admitted to the Department for Geriatric Medicine of the University of Cologne, that have a serum sodium of below 130 mmol/L on admission, and that have complete datasets that allow for unequivocal determination of the etiologic cause of hyponatremia will be enrolled in this study.
Key inclusion criteria (2 listed)
- age of 70 years or above
- serum sodium of 130 mmol/L and below
Key exclusion criteria (2 listed)
- patients not capable of giving informed consent
- patients on intensive care unit (ICU)
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 |
|---|---|---|
| Multidimensional Geriatric Assessment (MGA)The MGA contains the following tests: 1. Barthel Katz Index (activity of daily living, ADL) 2. Mini Mental State Test (MMST) 3. DemTec (dementia detection test) 4. Clock Test 5. Geriatric Depression Scale (GDS) 6. Tinetti Test 7. TUG (timed up-and-go Test) 8. Esslinger Transfer Scale (ETS) 9. Handgrip Test 10. Mini Nutritional Assessment (MNA) | Other | Not treatment |
Primary outcome
Evaluation of the impact of serum sodium concentration on geriatric assessment scores.
Time frame: Day of admission - 14 to 21 days
The impact of serum sodium concentration on geriatric assessment scores will be evaluated individually for each assessment score in a linear model, independent variables being a) increment of serum sodium [mmol/L] from the time of the first MGA at hospital admission to the time of the second MGA prior to discharge, and b) baseline serum sodium [mmol/L] at the time of the first MGA at hospital admission, the dependent variable being change of assessment score. A subgroup analysis will be done for SIADH patients. The association between geriatric assessments and serum sodium [mmol/L] will be analysed by correlation analysis at the time of the first and second MGA.
1 secondary outcome
Influence of anaemia as a confounder.
Time frame: day of admission - 14 to 21 days
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 9 Aug 2019.
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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
Department II of Internal Medicine, Nephrology - University Hospital of Cologne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyponatremia, run by Volker Burst at 1 site in Germany.
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 2 inclusion and 2 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 9 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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?
Evaluation of the impact of serum sodium concentration on geriatric assessment scores. (time frame: Day of admission - 14 to 21 days). 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 9 Aug 2019.