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Hyponatremia in Elderly Patients With Hip Fractures

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ClinicalTrials.gov Identifier: NCT03456492
Recruitment Status : Not yet recruiting
First Posted : March 7, 2018
Last Update Posted : March 7, 2018
Sponsor:
Information provided by (Responsible Party):
Alshymaa Hassan Mohammed, 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 aim of this study is to compare incidence of hyponatremia in elderly patients (>70 years) with hip fractures (case group) to incidence of hyponatremia in elderly patients(>70 years) undergoing joint replacement or prostate surgery(control group).

Condition or disease Intervention/treatment
Hyponatremia in Elderly Diagnostic Test: serum sodium

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.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Hyponatremia in Elderly Patients With Hip Fractures: One Year Study
Estimated Study Start Date : April 1, 2018
Estimated Primary Completion Date : April 1, 2019
Estimated Study Completion Date : June 1, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
case
elderly patients (>70 years) with hip fractures
Diagnostic Test: serum sodium
Serum sodium will be measured on admission, day before surgery, day after and at discharge

control
elderly patients(>70 years) undergoing joint replacement or cataract surgery
Diagnostic Test: serum sodium
Serum sodium will be measured on admission, day before surgery, day after and at discharge




Primary Outcome Measures :
  1. to investigate the prevalence of hyponatremia in all hip fractures patients admitted to our hospital during the year of the study [ Time Frame: baseline ]

Secondary Outcome Measures :
  1. early diagnosis and treatment of hyponatremia to avoid fractures [ Time Frame: baseline ]


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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Elderly patients > 70 years
Criteria

Inclusion Criteria:

  • Elderly patients > 70 years with hip fractures (case group)
  • Elderly patients > 70 years undergoing undergoing joint replacement or prostate surgery (control group)

Exclusion Criteria:

  • Non

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03456492


Contacts
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Contact: AHMohammed 01067555351 mona.h2008@yahoo.com
Contact: Hassan Ibrahim Kotb, professor 020882321063

Sponsors and Collaborators
Assiut University
Investigators
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Study Chair: Emad Zarief Kamel, MD Associate professor of anesthesiology and ICU
Study Chair: Mohammed Ismail Sedek, MD Associate professor of clinical pathology

Additional Information:
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Responsible Party: Alshymaa Hassan Mohammed, Doctor, Assiut University
ClinicalTrials.gov Identifier: NCT03456492     History of Changes
Other Study ID Numbers: Hyponatremia in elderly
First Posted: March 7, 2018    Key Record Dates
Last Update Posted: March 7, 2018
Last Verified: March 2018

Additional relevant MeSH terms:
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Hyponatremia
Hip Fractures
Femoral Fractures
Fractures, Bone
Wounds and Injuries
Hip Injuries
Leg Injuries
Water-Electrolyte Imbalance
Metabolic Diseases