Hyponatremia in ElderlyNCT03456492
Hyponatremia in Elderly Patients With Fractures Around the Hip.
An observational study of Hyponatremia in Elderly, run by Assiut University at 1 site in Egypt.
Trial summary
Hyponatremia was defined as a serum sodium concentration <135 mmol/L that occurred at least once during a patient's hospital stay from admission to discharge. Elderly patients with fragility fractures are particularly susceptible to hyponatremia because of their impaired physiology, multiple comorbidities (such as… Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Hyponatremia in Elderly
- What is being tested?
- serum sodium
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2018to 1 Jun 2019
- 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
- Older adult
Study population: Elderly patients > 70 years
Who may be able to join
- Hyponatremic elderly patients > 70 years with hip fractures (case group) and surgical intervention will be done by spinal anesthesia so; a sample of CSF can be taken.
- Normonatremic elderly patients > 70 years undergoing undergoing joint replacement (control group) and surgical intervention will be done by spinal anesthesia so; a sample of CSF can be taken.
Who cannot join
- Age < 70 years
- Patients receive general anesthesia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hyponatremia in Elderly Patients With Fractures Around the Hip; Role of Glutamate (CSF Glutamate Study)
Hyponatremia was defined as a serum sodium concentration <135 mmol/L that occurred at least once during a patient's hospital stay from admission to discharge. Elderly patients with fragility fractures are particularly susceptible to hyponatremia because of their impaired physiology, multiple comorbidities (such as hypocortisolism, hypothyroidism, hepatic cirrhosis, renal disease, and congestive heart failure), polypharmacy (e.g., antihypertensives, antidepressants, and antiepileptics), hospitalization, perioperative fluid restrictions, and homeostatic stress from the fracture itself and the subsequent surgery.
The study has 2 parts:
Read more
Part 1: aims to to find incidence of hyponatremia in sample of 70 elderly patients with fractures around the hip, effect of hyponatremia on mental state of the patients by using Modified Mini-Mental state (3MS) examination and to find mortality rate for 6 months post admission.
Part 2: aims to compare sample of 18 elderly hyponatremic patients with fractures around the hip (case group) with sample of 10 elderly normonatremic patients with osteoartharitis of knee or hip who admitted for elective joint replacement (control group) as regards; serum sodium, 3M score, and CSF glutamate to find correlation between the cognitive status assessed by 3M score and CSF glutamate as a biomarker for hyponatremia.
Read the detailed description
These patients are also at a higher risk of the complications of hyponatremia such as brain injury, the main result of acute symptomatic hyponatremia and associated with significant morbidity and mortality. Severe hyponatremia (i.e., a serum sodium concentration <125 mmol/L) ), if unrecognized in its first stages and left untreated, has a high rate of mortality; for this reason, an accurate clinical assessment must be made, focusing on fluid status, examining the potential etiology, and conducting the appropriate investigations. In approximately 50% of patients, chronic hyponatremia results from inappropriate antidiuretic hormone secretion. Chronic mild hyponatremia is usually asymptomatic and is traditionally regarded as benign. However, it is associated with a lower bone mineral content and density in nearly all regions of the hip, with more pronounced losses in the trochanteric and femoral neck regions. It can also lead to osteoporosis, abnormal gait patterns, cognitive impairment, bone demineralization, respiratory failure, noncardiogenic pulmonary edema, falls, and fractures. Compared to normonatremic individuals, hyponatremic individuals are known to have a longer time from admission to surgery.
Glutamate which is the main excitatory neurotransmitter in our body may play role in implication of hyponatremia on the brain. Cerebrospinal fluid (CSF) sample can be taken while dripling during spinal anathesia for surgical intervention for determination of glutamate
- Conditions
- Hyponatremia in Elderly
- Being tested
- serum sodium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serum sodiumDiagnostic test
Also called 3M score, CSF glutamate
Serum sodium will be measured on admission, assesment of mental status by Modified Mini-Mental score and measurement of glutamate in CSF sample taken while dripling during spinal anathesia for surgical intervention.
| Study group | Role | What they receive |
|---|---|---|
| case | Hyponatremic elderly patients (>70 years) with hip fractures Receives: Diagnostic Test: serum sodium | |
| control | Normonatremic elderly patients(>70 years) undergoing joint replacement Receives: Diagnostic Test: serum sodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
To find correlation between the cognitive status assessed by 3M score and CSF glutamate as a biomarker for hyponatremia.
Measured: baseline
Secondary outcomes (1)
Early diagnosis and treatment of hyponatremia to avoid fractures
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2018
- Study start1 Apr 2018
- Primary completion1 Apr 2019
- Study completion1 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyponatremia in ElderlyStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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-control
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alshymaa Hassan Mohammed, Assiut University
- Investigators
- Emad Zarief Kamel, MD, Study chair, Associate professor of anesthesiology and ICUMohammed Ismail Sedek, MD, Study chair, Associate professor of clinical pathology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03456492
- Sponsor's protocol ID
- Hyponatremia in elderly
- Status last verified
- Oct 2020
- First submitted
- 13 Feb 2018
- Last updated
- 14 Oct 2020
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyponatremia in Elderly Patients With Fractures Around the Hip; Role of Glutamate (CSF Glutamate Study)
- ClinicalTrials.gov ID
- NCT03456492
- Acronym / sponsor ID
- Hyponatremia in elderly
- Conditions
- Hyponatremia in Elderly
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 7 Mar 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.
Hyponatremia was defined as a serum sodium concentration <135 mmol/L that occurred at least once during a patient's hospital stay from admission to discharge. Elderly patients with fragility fractures are particularly susceptible to hyponatremia because of their impaired physiology, multiple comorbidities (such as hypocortisolism, hypothyroidism, hepatic cirrhosis, renal disease, and congestive heart failure), polypharmacy (e.g., antihypertensives, antidepressants, and antiepileptics), hospitalization, perioperative fluid restrictions, and homeostatic stress from the fracture itself and the subsequent surgery.
The study has 2 parts:
Part 1: aims to to find incidence of hyponatremia in sample of 70 elderly patients with fractures around the hip, effect of hyponatremia on mental state of the patients by using Modified Mini-Mental state (3MS) examination and to find mortality rate for 6 months post admission.
Part 2: aims to compare sample of 18 elderly hyponatremic patients with fractures around the hip (case group) with sample of 10 elderly normonatremic patients with osteoartharitis of knee or hip who admitted for elective joint replacement (control group) as regards; serum sodium, 3M score, and CSF glutamate to find correlation between the cognitive status assessed by 3M score and CSF glutamate as a biomarker for hyponatremia.
Detailed description
These patients are also at a higher risk of the complications of hyponatremia such as brain injury, the main result of acute symptomatic hyponatremia and associated with significant morbidity and mortality. Severe hyponatremia (i.e., a serum sodium concentration <125 mmol/L) ), if unrecognized in its first stages and left untreated, has a high rate of mortality; for this reason, an accurate clinical assessment must be made, focusing on fluid status, examining the potential etiology, and conducting the appropriate investigations. In approximately 50% of patients, chronic hyponatremia results from inappropriate antidiuretic hormone secretion. Chronic mild hyponatremia is usually asymptomatic and is traditionally regarded as benign. However, it is associated with a lower bone mineral content and density in nearly all regions of the hip, with more pronounced losses in the trochanteric and femoral neck regions. It can also lead to osteoporosis, abnormal gait patterns, cognitive impairment, bone demineralization, respiratory failure, noncardiogenic pulmonary edema, falls, and fractures. Compared to normonatremic individuals, hyponatremic individuals are known to have a longer time from admission to surgery.
Glutamate which is the main excitatory neurotransmitter in our body may play role in implication of hyponatremia on the brain. Cerebrospinal fluid (CSF) sample can be taken while dripling during spinal anathesia for surgical intervention for determination of glutamate
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| case | – | Diagnostic Test: serum sodiumHyponatremic elderly patients (>70 years) with hip fractures |
| control | – | Diagnostic Test: serum sodiumNormonatremic elderly patients(>70 years) undergoing joint replacement |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Age groups
- Older adult
- Study population
- Elderly patients > 70 years
Key inclusion criteria (2 listed)
- Hyponatremic elderly patients > 70 years with hip fractures (case group) and surgical intervention will be done by spinal anesthesia so; a sample of CSF can be taken.
- Normonatremic elderly patients > 70 years undergoing undergoing joint replacement (control group) and surgical intervention will be done by spinal anesthesia so; a sample of CSF can be taken.
Key exclusion criteria (2 listed)
- Age < 70 years
- Patients receive general anesthesia.
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 sodiumAlso: 3M score, CSF glutamateSerum sodium will be measured on admission, assesment of mental status by Modified Mini-Mental score and measurement of glutamate in CSF sample taken while dripling during spinal anathesia for surgical intervention. | Diagnostic test | case, control |
Primary outcome
To find correlation between the cognitive status assessed by 3M score and CSF glutamate as a biomarker for hyponatremia.
Time frame: baseline
1 secondary outcome
Early diagnosis and treatment of hyponatremia to avoid fractures
Time frame: baseline
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 14 Oct 2020.
- Management of hyponatraemia in older people: old threats and new opportunitiesLink provided by the sponsor.
- what causes hyponatremia in elderly patients?Link provided by the sponsor.
- Prevalence of Hyponatremia in Elderly Patients with Hip Fractures: A Two-Year StudyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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.
Emad Zarief Kamel, MD study chair
Associate professor of anesthesiology and ICU
Mohammed Ismail Sedek, MD study chair
Associate professor of clinical pathology
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 in Elderly, run by Assiut University at 1 site in Egypt.
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 14 Oct 2020. 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 Egypt. 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?
To find correlation between the cognitive status assessed by 3M score and CSF glutamate as a biomarker for hyponatremia. (time frame: baseline). 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 14 Oct 2020.