Hyponatremia in Elderly Patients With Fractures Around the Hip.

Completed

• Conditions: Hyponatremia in Elderly
• Interventions: Diagnostic Test: serum sodium

• Registration Number: NCT03456492
• Lead Sponsor: Assiut University

Brief 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 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 Timeline

• Study First Submitted: 2018-02-13
• Study First Submitted QC: 2018-03-04
• Study First Posted: 2018-03-07
• Study Start: 2018-04-01
• Primary Completion: 2019-04-01
• Study Completion: 2019-06-01
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-10
• Last Update Posted: 2020-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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.

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Exclusion Criteria

• Age < 70 years
• Patients receive general anesthesia.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
case	serum sodium	Hyponatremic elderly patients (\>70 years) with hip fractures
control	serum sodium	Normonatremic elderly patients(\>70 years) undergoing joint replacement

Primary Outcome Measures

Name	Time	Method
To find correlation between the cognitive status assessed by 3M score and CSF glutamate as a biomarker for hyponatremia.	baseline

Secondary Outcome Measures

Name	Time	Method
Early diagnosis and treatment of hyponatremia to avoid fractures	baseline

Trial Locations

Locations (1)

Assiut University Hospital; 🇪🇬 Assiut, Egypt