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Hyponatremia in the Prevention of Hospitalized Patients Falls

Effectiveness of Early Intervention in the Diagnosis and Treatment of Hyponatremia in the Prevention of Hospitalized Patients Falls

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03265691
Acronym
PRECAHI
Enrollment
124
Registered
2017-08-29
Start date
2014-12-31
Completion date
2016-12-31
Last updated
2017-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Accidental Falls, Hyponatremia

Keywords

Accidental Falls, Hyponatremia, Elderly, Risk factors, Nurse

Brief summary

Cross ecological quasi-experimental study to assess effectiveness of early intervention in the diagnosis and treatment of hyponatremia in the prevention of hospitalized patients´ falls.

Detailed description

Effectiveness of early intervention in the diagnosis and treatment of hyponatremia in the prevention of hospitalized patients´ falls. Aims: 1. To assess the effectiveness of corrective activity of hyponatremia in falls reducing incidence. 2. To assess the cost-effectiveness ratio of the two proposed strategies: conventional treatment versus early intervention. Cross ecological quasi-experimental study. The project will take place in Gregorio Marañón Hospital (Madrid, Spain) in the following inpatient adult Units: Neurology, Rehabilitation 1, Geriatrics, Internal Medicine (Group A), Cardiology, Rehabilitation 2, Gastroenterology, Neurosurgery and Oncology (Group B). The estimated sample size for a confidence level of 95% (α = 0.05) and power of 90% (β = 0.010), taking into account a decrease in the incidence of falls of 20% restocking losses, is 124 patients per group (ie, the 124 patients receiving regular performance \*\* and 124 patients receiving the experimental intervention \*, if necessary, by participant Unit). Data collection: In each of the study participants Units both interventions will be held. First the participants Units have been randomized in two groups (Group A: Neurology, Rehabilitation 1, Geriatrics, Internal Medicine; Group B: Cardiology, Rehabilitation 2, Gastroenterology, Neurosurgery and Oncology). All patients hospitalized in these Units will be potentially included. First of all, collaborators will give them an informed consent to ask for their participation. The interventions are: * Experimental intervention: early diagnosis, treatment of hyponatremia until resolution and valuation according to the Dynamic Gait Index test. Duration: 6 months * Habitual action: the usual pattern of work will be performed in all patients who enter. Duration: 6 months.

Interventions

OTHEREarly detection and treatment of hyponatremia

In the experimental group, hyponatremia will be diagnosed and treated early. Therefore, the researchers will review the patients' sodium levels at admission and throughout their stay.

OTHERNo Intervention (SOC)

Usual pattern of work will be performed in all patients who enter in Hospital.

Sponsors

Fundación Mutua Madrileña
CollaboratorOTHER
Mª del Carmen Lobo Rodríguez
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age \>65 years * Admitted to a participating study unit * Wish to participate in the study and signature of informed consent.

Exclusion criteria

* Transfer of the patient to a unit not included in the study * Deterioration of the patient's condition to severe or extremely painful

Design outcomes

Primary

MeasureTime frameDescription
To evaluate the effectiveness of treatment of hyponatremia in reducing the incidence of falls.1 yearThe effectiveness will be measured in terms of less incidence of falls

Secondary

MeasureTime frameDescription
To evaluate the cost-effectiveness of the 2 strategies proposed: conventional treatment vs early intervention.1 yearThe cost-effectiveness will be indirectly measured using Average cost per inpatient day

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026