Mortality and Neurologic Outcomes in Rapid vs. Slow Hyponatremia Correction

NCT ID: NCT06675591

Last Updated: 2024-11-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 2037 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-03-01
• Study Completion Date: 2024-05-01

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.

Conditions

Hyponatremia; Hospitalisation; Mortality; SEVERE HYPONATREMIA

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Rapid group correction

Patients whose serum sodium increased by ≥ 8 mEq/L within the first 24 hours.

Rapid sodium correction

Intervention Type: OTHER

This study focuses on the exposure to different sodium correction rates in patients with severe hyponatremia (serum sodium ≤ 120 mEq/L) rather than an active intervention. The two key groups are defined by their rate of sodium correction during the first 24 hours of hospitalization:

Rapid Sodium Correction: An increase in serum sodium of ≥ 8 mEq/L within 24 hours.

Slow Sodium Correction: An increase in serum sodium of < 8 mEq/L within 24 hours.

The primary objective is to assess the association between these exposure rates and clinical outcomes, including in-hospital mortality, 30-day mortality, and the incidence of osmotic demyelination syndrome (ODS). This study differs from others by using a large, retrospective cohort of patients treated in a real-world clinical setting, spanning 13 years (2010-2023), and applying robust statistical adjustments such as propensity score analysis to control for confounders.

Slow group correction

Patients whose serum sodium increased by \< 8 mEq/L within the first 24 hours.

Slow sodium correction

Intervention Type: OTHER

This study focuses on the exposure to different sodium correction rates in patients with severe hyponatremia (serum sodium ≤ 120 mEq/L) rather than an active intervention. The two key groups are defined by their rate of sodium correction during the first 24 hours of hospitalization:

Rapid Sodium Correction: An increase in serum sodium of ≥ 8 mEq/L within 24 hours.

Slow Sodium Correction: An increase in serum sodium of &lt; 8 mEq/L within 24 hours.

The primary objective is to assess the association between these exposure rates and clinical outcomes, including in-hospital mortality, 30-day mortality, and the incidence of osmotic demyelination syndrome (ODS). This study differs from others by using a large, retrospective cohort of patients treated in a real-world clinical setting, spanning 13 years (2010-2023), and applying robust statistical adjustments such as propensity score analysis to control for confounders.

Interventions

Rapid sodium correction

This study focuses on the exposure to different sodium correction rates in patients with severe hyponatremia (serum sodium ≤ 120 mEq/L) rather than an active intervention. The two key groups are defined by their rate of sodium correction during the first 24 hours of hospitalization:

Rapid Sodium Correction: An increase in serum sodium of ≥ 8 mEq/L within 24 hours.

Slow Sodium Correction: An increase in serum sodium of &lt; 8 mEq/L within 24 hours.

The primary objective is to assess the association between these exposure rates and clinical outcomes, including in-hospital mortality, 30-day mortality, and the incidence of osmotic demyelination syndrome (ODS). This study differs from others by using a large, retrospective cohort of patients treated in a real-world clinical setting, spanning 13 years (2010-2023), and applying robust statistical adjustments such as propensity score analysis to control for confounders.

Intervention Type: OTHER

Slow sodium correction

This study focuses on the exposure to different sodium correction rates in patients with severe hyponatremia (serum sodium ≤ 120 mEq/L) rather than an active intervention. The two key groups are defined by their rate of sodium correction during the first 24 hours of hospitalization:

Rapid Sodium Correction: An increase in serum sodium of ≥ 8 mEq/L within 24 hours.

Slow Sodium Correction: An increase in serum sodium of &lt; 8 mEq/L within 24 hours.

The primary objective is to assess the association between these exposure rates and clinical outcomes, including in-hospital mortality, 30-day mortality, and the incidence of osmotic demyelination syndrome (ODS). This study differs from others by using a large, retrospective cohort of patients treated in a real-world clinical setting, spanning 13 years (2010-2023), and applying robust statistical adjustments such as propensity score analysis to control for confounders.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, Irvine

OTHER

Sponsor Role: collaborator

Hospital Privado de Comunidad de Mar del Plata

OTHER

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: collaborator

Hospital Italiano de Buenos Aires

OTHER

Sponsor Role: lead

Responsible Party

ANACLARA MURUJOSA

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hospital Italiano de Buenos Aires

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Countries

Argentina

References

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Other Identifiers

10042

Identifier Type: OTHER

Identifier Source: secondary_id

6756

Identifier Type: -

Identifier Source: org_study_id