HyponatremiaRASC-HypoNaNCT06675591
Mortality and Neurologic Outcomes in Rapid vs. Slow Hyponatremia Correction
An observational study of Hyponatremia and Hospitalisation, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyponatremia, Hospitalisation, Mortality
- What is being tested?
- Rapid sodium correction and Slow sodium correction
- How many people
- 2,037 participants
- Where
- 1 siteArgentina
- Study dates
- 1 Mar 2024to 1 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Argentina1 site
Hospital Italiano de Buenos Aires
Ciudad Autónoma de Buenos Aires, Buenos Aires, C1199ABB
About this study
Official title: Mortality and Neurologic Complications Associated With Rapid Versus Slow Correction of Hyponatremia
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
- Being tested
- Rapid sodium correction, Slow sodium correction
- Keywords
- severe hyponatremia, sodium correction, Osmotic Demyelination Syndrome, rapid sodium correction, In-Hospital Mortality, cohort study
- Medical subject headings
- Hyponatremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rapid sodium correctionOther
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 sodium correctionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Rapid group correction | Patients whose serum sodium increased by ≥ 8 mEq/L within the first 24 hours. Receives: Other: Rapid sodium correction | |
| Slow group correction | Patients whose serum sodium increased by < 8 mEq/L within the first 24 hours. Receives: Other: Slow sodium correction |
What is being measured
The primary outcome is the main question the study is designed to answer.
In-Hospital Mortality
In-Hospital Mortality refers to the occurrence of death from any cause during a patients hospital stay. In the context of this study, it specifically measures the rate at which patients with severe hyponatremia (serum sodium ≤ 120 mEq/L) die before being discharged from the hospital.
Measured: From hospital admission to discharge or death. To evalute in-Hospital mortality we will use logistic regression, not time to event analysis.
Secondary outcomes (3)
30-Day Mortality
30-Day Mortality refers to the occurrence of death from any cause within 30 days following a patient\'s admission to the hospital. In this study, it measures the mortality rate of patients with severe hyponatremia (serum sodium ≤ 120 mEq/L) within 30 days after hospitalization, regardless of whether they were discharged or remained in the hospital.
Measured: 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.
Length of stay
Length of Stay (LOS) refers to the duration of a patient\'s hospitalization, measured from the date of admission to the date of discharge. In this study, it evaluates how long patients with severe hyponatremia (serum sodium ≤ 120 mEq/L) remain in the hospital and assesses whether the rate of sodium correction (rapid vs. slow) influences their hospital stay.
Measured: From the date of hospital admission to the date of discharge
Incidence of Osmotic Demyelinitation Syndrome (ODS)
Incidence of Osmotic Demyelination Syndrome (ODS) refers to the number of new cases of ODS that occur in patients during or after the correction of severe hyponatremia (serum sodium ≤ 120 mEq/L).
Measured: From the date of hospital admission through hospital discharge, up to 180 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2024
- Study start1 Mar 2024
- Primary completion30 Apr 2024
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for HyponatremiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,037 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Italiano de Buenos Aires
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Irvine, Hospital Privado de Comunidad de Mar del Plata, University of Pittsburgh
- Responsible party
- Principal investigator, ANACLARA MURUJOSA, Hospital Italiano de Buenos Aires
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06675591
- Sponsor's protocol ID
- 6756
- Other IDs
- 10042
- Acronym
- RASC-HypoNa
- Status last verified
- Sep 2024
- First submitted
- 14 Sep 2024
- Last updated
- 5 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hoorn EJ, Halperin ML, Zietse R. Diagnostic approach to a patient with hyponatraemia: traditional versus physiology-based options. QJM. 2005 Jul;98(7):529-40. doi: 10.1093/qjmed/hci081. Epub 2005 Jun 13.
PubMed 15955797Whelan B, Bennett K, O'Riordan D, Silke B. Serum sodium as a risk factor for in-hospital mortality in acute unselected general medical patients. QJM. 2009 Mar;102(3):175-82. doi: 10.1093/qjmed/hcn165. Epub 2008 Dec 23.
PubMed 19106156Kovesdy CP, Lott EH, Lu JL, Malakauskas SM, Ma JZ, Molnar MZ, Kalantar-Zadeh K. Hyponatremia, hypernatremia, and mortality in patients with chronic kidney disease with and without congestive heart failure. Circulation. 2012 Feb 7;125(5):677-84. doi: 10.1161/CIRCULATIONAHA.111.065391. Epub 2012 Jan 5.
PubMed 22223429Mohan S, Gu S, Parikh A, Radhakrishnan J. Prevalence of hyponatremia and association with mortality: results from NHANES. Am J Med. 2013 Dec;126(12):1127-37.e1. doi: 10.1016/j.amjmed.2013.07.021.
PubMed 24262726Heuman DM, Abou-Assi SG, Habib A, Williams LM, Stravitz RT, Sanyal AJ, Fisher RA, Mihas AA. Persistent ascites and low serum sodium identify patients with cirrhosis and low MELD scores who are at high risk for early death. Hepatology. 2004 Oct;40(4):802-10. doi: 10.1002/hep.20405.
PubMed 15382176Abebe TB, Gebreyohannes EA, Tefera YG, Bhagavathula AS, Erku DA, Belachew SA, Gebresillassie BM, Abegaz TM. The prognosis of heart failure patients: Does sodium level play a significant role? PLoS One. 2018 Nov 8;13(11):e0207242. doi: 10.1371/journal.pone.0207242. eCollection 2018.
PubMed 30408132Xiao M, Wang X, Wang H, Du F, Yao Y, Wang X, Wang J, Yang J, Xiong W, Wang Q, Ren X, Zhu T. Risk factors for hyponatremia in acute exacerbation chronic obstructive pulmonary disease (AECOPD): a multicenter cross-sectional study. BMC Pulm Med. 2023 Jan 28;23(1):39. doi: 10.1186/s12890-023-02328-4.
PubMed 36709254Seethapathy 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.
PubMed 38320180Kinoshita T, Mlodzinski E, Xiao Q, Sherak R, Raines NH, Celi LA. Effects of correction rate for severe hyponatremia in the intensive care unit on patient outcomes. J Crit Care. 2023 Oct;77:154325. doi: 10.1016/j.jcrc.2023.154325. Epub 2023 May 13.
PubMed 37187000
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mortality and Neurologic Complications Associated With Rapid Versus Slow Correction of Hyponatremia
- ClinicalTrials.gov ID
- NCT06675591
- Acronym / sponsor ID
- RASC-HypoNa / 6756
- Conditions
- Hyponatremia, Hospitalisation, Mortality, SEVERE HYPONATREMIA
- Keywords
- severe hyponatremia, sodium correction, Osmotic Demyelination Syndrome, rapid sodium correction, In-Hospital Mortality, cohort study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,037 participants (actual)
- Lead sponsor
- Hospital Italiano de Buenos AiresUniversity, hospital or other
- Collaborators
- University of California, Irvine, Hospital Privado de Comunidad de Mar del Plata, University of Pittsburgh
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 5 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rapid group correction | – | Other: Rapid sodium correctionPatients whose serum sodium increased by ≥ 8 mEq/L within the first 24 hours. |
| Slow group correction | – | Other: Slow sodium correctionPatients whose serum sodium increased by < 8 mEq/L within the first 24 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rapid sodium correctionThis 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. | Other | Rapid group correction |
| Slow sodium correctionThis 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. | Other | Slow group correction |
Primary outcome
In-Hospital Mortality
Time frame: From hospital admission to discharge or death. To evalute in-Hospital mortality we will use logistic regression, not time to event analysis.
In-Hospital Mortality refers to the occurrence of death from any cause during a patients hospital stay. In the context of this study, it specifically measures the rate at which patients with severe hyponatremia (serum sodium ≤ 120 mEq/L) die before being discharged from the hospital.
3 secondary outcomes
30-Day Mortality
Time frame: 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.
Length of stay
Time frame: From the date of hospital admission to the date of discharge
Incidence of Osmotic Demyelinitation Syndrome (ODS)
Time frame: From the date of hospital admission through hospital discharge, up to 180 days.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2024.
- Background: PubMed 15955797Hoorn EJ, Halperin ML, Zietse R. Diagnostic approach to a patient with hyponatraemia: traditional versus physiology-based options. QJM. 2005 Jul;98(7):529-40. doi: 10.1093/qjmed/hci081. Epub 2005 Jun 13.
- Background: PubMed 19106156Whelan B, Bennett K, O'Riordan D, Silke B. Serum sodium as a risk factor for in-hospital mortality in acute unselected general medical patients. QJM. 2009 Mar;102(3):175-82. doi: 10.1093/qjmed/hcn165. Epub 2008 Dec 23.
- Background: PubMed 22223429Kovesdy CP, Lott EH, Lu JL, Malakauskas SM, Ma JZ, Molnar MZ, Kalantar-Zadeh K. Hyponatremia, hypernatremia, and mortality in patients with chronic kidney disease with and without congestive heart failure. Circulation. 2012 Feb 7;125(5):677-84. doi: 10.1161/CIRCULATIONAHA.111.065391. Epub 2012 Jan 5.
- Background: PubMed 24262726Mohan S, Gu S, Parikh A, Radhakrishnan J. Prevalence of hyponatremia and association with mortality: results from NHANES. Am J Med. 2013 Dec;126(12):1127-37.e1. doi: 10.1016/j.amjmed.2013.07.021.
- Background: PubMed 15382176Heuman DM, Abou-Assi SG, Habib A, Williams LM, Stravitz RT, Sanyal AJ, Fisher RA, Mihas AA. Persistent ascites and low serum sodium identify patients with cirrhosis and low MELD scores who are at high risk for early death. Hepatology. 2004 Oct;40(4):802-10. doi: 10.1002/hep.20405.
- Background: PubMed 30408132Abebe TB, Gebreyohannes EA, Tefera YG, Bhagavathula AS, Erku DA, Belachew SA, Gebresillassie BM, Abegaz TM. The prognosis of heart failure patients: Does sodium level play a significant role? PLoS One. 2018 Nov 8;13(11):e0207242. doi: 10.1371/journal.pone.0207242. eCollection 2018.
- Background: PubMed 36709254Xiao M, Wang X, Wang H, Du F, Yao Y, Wang X, Wang J, Yang J, Xiong W, Wang Q, Ren X, Zhu T. Risk factors for hyponatremia in acute exacerbation chronic obstructive pulmonary disease (AECOPD): a multicenter cross-sectional study. BMC Pulm Med. 2023 Jan 28;23(1):39. doi: 10.1186/s12890-023-02328-4.
- Background: PubMed 38320180Seethapathy 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.
- Background: PubMed 37187000Kinoshita T, Mlodzinski E, Xiao Q, Sherak R, Raines NH, Celi LA. Effects of correction rate for severe hyponatremia in the intensive care unit on patient outcomes. J Crit Care. 2023 Oct;77:154325. doi: 10.1016/j.jcrc.2023.154325. Epub 2023 May 13.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyponatremia and Hospitalisation, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In-Hospital Mortality (time frame: From hospital admission to discharge or death. To evalute in-Hospital mortality we will use logistic regression, not time to event analysis.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06675591, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2024.