Clinical trial NCT06675591: Mortality and Neurologic Outcomes in Rapid vs. Slow Hyponatremia Correction
Official title: Mortality and Neurologic Complications Associated With Rapid Versus Slow Correction of Hyponatremia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hyponatremia
Hospitalisation
Mortality
SEVERE HYPONATREMIA
Keywords: severe hyponatremia
sodium correction
Osmotic Demyelination Syndrome
rapid sodium correction
In-Hospital Mortality
cohort study
Lead sponsor: Hospital Italiano de Buenos Aires
Sponsor class: OTHER
Collaborators: name: University of California, Irvine
name: Hospital Privado de Comunidad de Mar del Plata
name: University of Pittsburgh
First posted: 2024-11-05
Enrollment: 2037
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consists of adult patients aged 18 years or older who were admitted to Hospital Italiano de Buenos Aires between 2010 and 2023 with severe hyponatremia, defined as a serum sodium (natremia) level of ≤ 120 mEq/L at the time of admission. The study focuses on patients experiencing their first hospitalization for this condition, with a hospital stay exceeding 24 hours to ensure sufficient follow-up for sodium correction. Patients with prior hospitalizations for severe hyponatremia or incomplete follow-up data were excluded to ensure accurate analysis of treatment outcomes.

Brief summary: This study examines the impact of different rates of sodium correction on the outcomes of patients with severe hyponatremia (serum sodium ≤ 120 mEq/L). Hyponatremia is a condition where blood sodium levels are dangerously low, and its treatment must be carefully managed to avoid complications. Standard guidelines recommend correcting sodium levels slowly to prevent a rare but serious neurological condition called osmotic demyelination syndrome (ODS). However, recent evidence suggests that a faster rate of sodium correction may reduce hospital stay length and mortality without increasing the risk of ODS.

This retrospective study, conducted from 2010 to 2023 at a hospital in Buenos Aires, Argentina. It compares the outcomes of patients who had their sodium levels corrected rapidly (≥ 8 mEq/L in 24 hours) to those who had slower corrections. The primary outcomes measured are mortality and the development of ODS.


Eligibility criteria: Inclusion Criteria:

* Patients aged 18 years or older.
* First hospitalization at Hospital Italiano de Buenos Aires with a serum sodium (natremia) level ≤ 120 mEq/L at admission.

Exclusion Criteria:

* Absence of serum sodium values after the first 24 hours of hospitalization.
* Hospitalizations shorter than 24 hours.
* Patients with previous hospitalizations prior to the study period where admission serum sodium levels were ≤ 120 mEq/L.

Primary outcomes:
measure: In-Hospital Mortality
timeFrame: From hospital admission to discharge or death. To evalute in-Hospital mortality we will use logistic regression, not time to event analysis.
Secondary outcomes:
measure: 30-Day Mortality
timeFrame: From the date of hospital admission up to 30 days. From hospital admission to discharge or death. To evalute 30-Day mortality we will use logistic regression, not time to event analysis.
measure: Length of stay
timeFrame: From the date of hospital admission to the date of discharge
measure: Incidence of Osmotic Demyelinitation Syndrome (ODS)
timeFrame: From the date of hospital admission through hospital discharge, up to 180 days.
Other outcomes:
Locations:
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Hospital Italiano de Buenos Aires
state: Buenos Aires
Study officials:
References:
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citation: Seethapathy H, Zhao S, Ouyang T, Passos C, Sarang A, Cheung PW, Waikar SS, Steele DJR, Kalim S, Allegretti AS, Ayus JC, Nigwekar SU. Severe Hyponatremia Correction, Mortality, and Central Pontine Myelinolysis. NEJM Evid. 2023 Oct;2(10):EVIDoa2300107. doi: 10.1056/EVIDoa2300107. Epub 2023 Sep 26.
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