Hyponatremia in Elderly Patients With Fractures Around the Hip.

NCT03456492 | Completed

• 1 other identifier: Hyponatremia in elderly
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyponatremia in Elderly

Outcome Measures

Primary Outcomes (1)

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

  baseline

Secondary Outcomes (1)

• Early diagnosis and treatment of hyponatremia to avoid fractures

  baseline

Study Arms (2)

case

Hyponatremic elderly patients (\>70 years) with hip fractures

Diagnostic Test: serum sodium

control

Normonatremic elderly patients(\>70 years) undergoing joint replacement

Diagnostic Test: serum sodium

Interventions

serum sodium DIAGNOSTIC_TEST

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.

Also known as: 3M score, CSF glutamate

case; control

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Elderly patients \> 70 years

You may qualify if:

• 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.

You may not qualify if:

• Age \< 70 years
• Patients receive general anesthesia.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University Hospital

Asyut, Egypt

Location

Related Links

• Management of hyponatraemia in older people: old threats and new opportunities
• what causes hyponatremia in elderly patients?
• Prevalence of Hyponatremia in Elderly Patients with Hip Fractures: A Two-Year Study

Study Officials

• Emad Zarief Kamel, MD

  Associate professor of anesthesiology and ICU

  STUDY CHAIR

• Mohammed Ismail Sedek, MD

  Associate professor of clinical pathology

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: February 13, 2018
• First Posted: March 7, 2018
• Study Start: April 1, 2018
• Primary Completion: April 1, 2019
• Study Completion: June 1, 2019
• Last Updated: October 14, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)