- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03456492
Hyponatremia in Elderly Patients With Fractures Around the Hip.
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:
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Assiut, Egypt
- Assiut University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Age < 70 years
- Patients receive general anesthesia.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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case
Hyponatremic elderly patients (>70 years) with hip fractures
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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.
Other Names:
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control
Normonatremic elderly patients(>70 years) undergoing joint replacement
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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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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To find correlation between the cognitive status assessed by 3M score and CSF glutamate as a biomarker for hyponatremia.
Time Frame: baseline
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baseline
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Early diagnosis and treatment of hyponatremia to avoid fractures
Time Frame: baseline
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baseline
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Emad Zarief Kamel, MD, Associate professor of anesthesiology and ICU
- Study Chair: Mohammed Ismail Sedek, MD, Associate professor of clinical pathology
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Hyponatremia in elderly
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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