HypernatremiaPhase 4SALSAIINCT04949139
Efficacy and Safety of Rapid Intermittent Correction Compared With Slow Continuous Correction in Patients With Severe Hypernatremia
A Phase 4 study testing Dextrose 5% in water in people with Hypernatremia, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This study will evaluate the efficacy and safety of rapid intermittent correction and slow correction with an electrolyte-free solution in patients with severe hypernatremia (glucose-corrected serum sodium, ≥ 155 mmol/L). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypernatremia
- What is being tested?
- Dextrose 5% in water
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 May 2021to 22 Feb 2025
- Phase
- Phase 4
- 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
Who may be able to join
- Patients who visit the emergency department and in-patients over 18 years
- Severe hypernatremia: glucose-corrected serum sodium ≥ 155 mmol/L
- Written consent
Who cannot join
- Arterial hypotension requiring inotropes or vasopressors (systolic blood pressure < 90 mmHg and mean arterial pressure < 70 mmHg)
- Anuria or bilateral urinary outlet obstruction
- Uncontrolled diabetes mellitus (HbA1C > 9%) or glucose at baseline > 500 mg/dL or uncontrolled diabetic ketoacidosis or uncontrolled hyperosmolar hyperglycemic syndrome
- Decompensated liver cirrhosis (LC) - Known LC with ascites or diuretic use or hepatic encephalopathy or varix
- End-stage renal disease receiving renal replacement therapy
- Uncontrolled Heart failure (regardless of LVEF)
Show all 12Show fewer
- Women who are pregnant or breast feeding
- Patients with the following conditions within 30 days prior to randomization:
- History of cardiac surgery excluding PCA, acute myocardial infarction, sustained ventricular tachycardia, ventricular fibrillation, acute coronary syndrome, and admission for heart failure
- Uncontrolled increase of intracranial pressure
- The subjects judged by investigators to have difficulty continuing the trial were also excluded.
- The case the subjects does not consent to the study
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Hallym University Dongtan Sacred Heart Hospital
Hwaseong-si, Gyeonggi-do, 18450
About this study
Official title: Efficacy and Safety of Rapid Intermittent Correction Compared With Slow Continuous Correction in Patients With Severe Hypernatremia (SALSA II Trial)
This study will evaluate the efficacy and safety of rapid intermittent correction and slow correction with an electrolyte-free solution in patients with severe hypernatremia (glucose-corrected serum sodium, ≥ 155 mmol/L).
Read the detailed description
Hypernatremia is defined as serum sodium (sNa) levels above 145 mmol/L and is caused by abnormalities in water balance, mainly in children, elderly, and critically ill patients. It occurs in 3% of hospitalized patients and in 9% of critically ill patients. Hypernatremia indicates hypertonic hyperosmolality and causes water outflow, resulting in cell dehydration. Most of the symptoms and signs of hypernatremia are due to brain abnormalities, which can progress to hyperventilation, muscle weakness, consciousness (lethargy), and coma. The short-term mortality rate of hypernatremia is 50%-60%. Decreased osmotic pressure in the extracellular fluid during correction of hyponatremia can cause cellular edema and permanent brain damage. The recommended sNa correction rate for acute hypernatremia is up to 1 mmol/L/h, whereas that for chronic hypernatremia is less than 0.5 mmol/L/h (approximately 10 mmol/L/day). However, these correction rates have only been studied and proven in pediatric patients. A recent study conducted on adults revealed that rapid correction (more than 0.5 mmol/L/h) was not associated with a higher risk for mortality, seizures, and alteration of consciousness. Several studies reported that excessively slow rates of sNa correction were associated with higher mortality, whereas rapid rates demonstrated lower mortality. There are no established guidelines for the Na correction rate for hypernatremia. The European and American guidelines recommend infusion of electrolyte-free water (10 mL/kg over 1 h or 3 mL/kg/h) for the management of overcorrection of hyponatremia. In the previously published SALSA I trial, 10 mL/kg over 1 h was applied as a method of re-lowering treatment in overly rapid correction of hyponatremia. However, this rapid intermittent bolus of electrolyte-free water has never been applied to treat hypernatremia.
The aim of this prospective, randomized, open-labeled, multi-center, and investigator-initiated trial is to determine whether a rapid and intermittent bolus of electrolyte-free water in hypernatremia can increase the incidence of rapid decrease in sNa level and increase the survival time compared to the slow continuous administration method. A total of 166 patients with severe hypernatremia will be enrolled and randomly assigned to receive either intermittent bolus or slow continuous infusion of 5% dextrose water. The participants will be divided into three groups according to age and sex and will receive 5% dextrose water for 2 days at different correction rates. Serum sodium will be measured every 3 h from the beginning to 6 h, followed by every 6 h until 48 h. In addition, urine sodium and potassium levels will be measured at baseline and 24 h. The PP (Per Protocol) analysis will be applied to enrolled participants who is infused with 75-125% of total planned volume of 5% dextrose water.
- Conditions
- Hypernatremia
- Being tested
- Dextrose 5% in water
- Keywords
- Hypernatremia, Treatment, 5% dextrose water
- Medical subject headings
- Hypernatremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dextrose 5% in waterDrug
Reducing the sodium concentration
| Study group | Role | What they receive |
|---|---|---|
| Rapid intermittent bolus group | Active comparator | A : males < 65 ; B : females < 65 or males ≥ 65 ; C : females ≥ 65 yrs
<During the first 3 h>
Primary treatment over 1h A: 5DW 8 B: 5DW 7 C: 5DW 6 mL/kg
If undercorrected, Repeat the 5DW amount infused during primary treatment after 3 h
<At 3-24 h> Modify protocol based on sNa at each time point (6/12/18/24 h)
Check U/S ratio at 0 h
* undercorrection < 0.5: repeat the amount infused during primary treatment q 3 h
≥ 0.5: repeat the amount infused during primary treatment q 6 h
* target correction < 0.5: repeat the amount infused during primary treatment q 6 h ≥ 0.5: stop the infusion
<At 24-48 h> Modify protocol based on sNa at each time point (30/36/42/48 h)
Check U/S ratio at 24 h
* undercorrection < 0.5: repeat the amount infused during primary treatment q 3 h
≥ 0.5: repeat the amount infused during primary treatment q 6 h
* target correction < 0.5: repeat the amount infused during primary treatment q 6 h ≥ 0.5: stop the infusion Receives: Drug: Dextrose 5% in water |
| Slow continuous infusion group | Active comparator | Participants will be divided into three groups same as above
<During the first 3 h>
Primary treatment A: 5DW 1.8 B: 5DW 1.57 C: 5DW 1.35 mL/kg/h
Modify protocol as described below based on sNa measurement at 3 h
* undercorrection: maintain the infusion rate
* target correction: stop the infusion
<At 3-24 h> Modify protocol based on sNa measurement at each time point (6/12/18/24 h)
Check U/S ratio at 0 h
• undercorrection
< 0.5: increase the infusion rate to twice that of the primary treatment
≥ 0.5: maintain the infusion rate
• target correction
< 0.5: maintain the infusion rate
≥ 0.5: stop the infusion
<At 24-48 h> Modify protocol based on sNa measurement at each time point (30/36/42/48 h)
Check U/S ratio at 24 h
• undercorrection
< 0.5: increase the infusion rate to twice that of the primary treatment
≥ 0.5: maintain the infusion rate
• target correction
< 0.5: maintain the infusion rate
≥ 0.5: stop the infusion Receives: Drug: Dextrose 5% in water |
What is being measured
The primary outcome is the main question the study is designed to answer.
efficacy : Incidence of rapid change in sNa level within 24 hours defined as follows
Change in sNa by ≥ 6 mmol/L or Na ≤ 150 mmol/L within 24 hours All subjects will receive 5% dextrose water by rapid intermittent bolus or slow continuous infusion for 48 h, and sNa levels will be measured.
Measured: up to 24 hours
Secondary outcomes (4)
the 28-day survival rate
survival rate
Measured: up to 28 days
difference in sNa levels 6 hours after the initial test
Gap of sodium level between 6 hours and initial level
Measured: up to 6 hours
volume of 5% dextrose water infused during 48 hours
Volume
Measured: up to 48 hours
Incidence of rapid change in sNa level within 48 hours defined as follows
Change in sNa by ≥ 12 mmol/L or Na ≤ 150 mmol/L within 48 hours
Measured: up to 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2021
- Study start1 May 2021
- Primary completion23 Jan 2025
- Study completion22 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for HypernatremiaStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sejoong Kim, PhD, Study director, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04949139
- Sponsor's protocol ID
- B-2104-680-003
- Acronym
- SALSAII
- Status last verified
- Apr 2025
- First submitted
- 6 Jun 2021
- Last updated
- 29 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Qian Q. Hypernatremia. Clin J Am Soc Nephrol. 2019 Mar 7;14(3):432-434. doi: 10.2215/CJN.12141018. Epub 2019 Feb 6. No abstract available.
PubMed 30728169Chauhan K, Pattharanitima P, Patel N, Duffy A, Saha A, Chaudhary K, Debnath N, Van Vleck T, Chan L, Nadkarni GN, Coca SG. Rate of Correction of Hypernatremia and Health Outcomes in Critically Ill Patients. Clin J Am Soc Nephrol. 2019 May 7;14(5):656-663. doi: 10.2215/CJN.10640918. Epub 2019 Apr 4.
PubMed 30948456Hillier TA, Abbott RD, Barrett EJ. Hyponatremia: evaluating the correction factor for hyperglycemia. Am J Med. 1999 Apr;106(4):399-403. doi: 10.1016/s0002-9343(99)00055-8.
PubMed 10225241Adrogue HJ, Madias NE. Hypernatremia. N Engl J Med. 2000 May 18;342(20):1493-9. doi: 10.1056/NEJM200005183422006. No abstract available.
PubMed 10816188Sterns RH. Evidence for Managing Hypernatremia: Is It Just Hyponatremia in Reverse? Clin J Am Soc Nephrol. 2019 May 7;14(5):645-647. doi: 10.2215/CJN.02950319. Epub 2019 Apr 4. No abstract available.
PubMed 31064771Cabassi A, Tedeschi S. Severity of community acquired hypernatremia is an independent predictor of mortality: a matter of water balance and rate of correction. Intern Emerg Med. 2017 Oct;12(7):909-911. doi: 10.1007/s11739-017-1693-x. Epub 2017 Jul 1. No abstract available.
PubMed 28669048Lindner G, Funk GC. Hypernatremia in critically ill patients. J Crit Care. 2013 Apr;28(2):216.e11-20. doi: 10.1016/j.jcrc.2012.05.001. Epub 2012 Jul 2.
PubMed 22762930Bataille S, Baralla C, Torro D, Buffat C, Berland Y, Alazia M, Loundou A, Michelet P, Vacher-Coponat H. Undercorrection of hypernatremia is frequent and associated with mortality. BMC Nephrol. 2014 Feb 21;15:37. doi: 10.1186/1471-2369-15-37.
PubMed 24559470Alshayeb HM, Showkat A, Babar F, Mangold T, Wall BM. Severe hypernatremia correction rate and mortality in hospitalized patients. Am J Med Sci. 2011 May;341(5):356-60. doi: 10.1097/MAJ.0b013e31820a3a90.
PubMed 21358313Sterns RH, Silver SM. Salt and water: read the package insert. QJM. 2003 Aug;96(8):549-52. doi: 10.1093/qjmed/hcg102. No abstract available.
PubMed 12897339Spasovski G, Vanholder R, Allolio B, Annane D, Ball S, Bichet D, Decaux G, Fenske W, Hoorn EJ, Ichai C, Joannidis M, Soupart A, Zietse R, Haller M, van der Veer S, Van Biesen W, Nagler E; Hyponatraemia Guideline Development Group. Clinical practice guideline on diagnosis and treatment of hyponatraemia. Eur J Endocrinol. 2014 Feb 25;170(3):G1-47. doi: 10.1530/EJE-13-1020. Print 2014 Mar.
PubMed 24569125
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Rapid Intermittent Correction Compared With Slow Continuous Correction in Patients With Severe Hypernatremia (SALSA II Trial)
- ClinicalTrials.gov ID
- NCT04949139
- Acronym / sponsor ID
- SALSAII / B-2104-680-003
- Conditions
- Hypernatremia
- Keywords
- Hypernatremia, Treatment, 5% dextrose water
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 23 Jan 2025 (actual)
- Study completion
- 22 Feb 2025 (actual)
- First posted
- 2 Jul 2021 (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 will evaluate the efficacy and safety of rapid intermittent correction and slow correction with an electrolyte-free solution in patients with severe hypernatremia (glucose-corrected serum sodium, ≥ 155 mmol/L).
Detailed description
Hypernatremia is defined as serum sodium (sNa) levels above 145 mmol/L and is caused by abnormalities in water balance, mainly in children, elderly, and critically ill patients. It occurs in 3% of hospitalized patients and in 9% of critically ill patients. Hypernatremia indicates hypertonic hyperosmolality and causes water outflow, resulting in cell dehydration. Most of the symptoms and signs of hypernatremia are due to brain abnormalities, which can progress to hyperventilation, muscle weakness, consciousness (lethargy), and coma. The short-term mortality rate of hypernatremia is 50%-60%. Decreased osmotic pressure in the extracellular fluid during correction of hyponatremia can cause cellular edema and permanent brain damage. The recommended sNa correction rate for acute hypernatremia is up to 1 mmol/L/h, whereas that for chronic hypernatremia is less than 0.5 mmol/L/h (approximately 10 mmol/L/day). However, these correction rates have only been studied and proven in pediatric patients. A recent study conducted on adults revealed that rapid correction (more than 0.5 mmol/L/h) was not associated with a higher risk for mortality, seizures, and alteration of consciousness. Several studies reported that excessively slow rates of sNa correction were associated with higher mortality, whereas rapid rates demonstrated lower mortality. There are no established guidelines for the Na correction rate for hypernatremia. The European and American guidelines recommend infusion of electrolyte-free water (10 mL/kg over 1 h or 3 mL/kg/h) for the management of overcorrection of hyponatremia. In the previously published SALSA I trial, 10 mL/kg over 1 h was applied as a method of re-lowering treatment in overly rapid correction of hyponatremia. However, this rapid intermittent bolus of electrolyte-free water has never been applied to treat hypernatremia.
The aim of this prospective, randomized, open-labeled, multi-center, and investigator-initiated trial is to determine whether a rapid and intermittent bolus of electrolyte-free water in hypernatremia can increase the incidence of rapid decrease in sNa level and increase the survival time compared to the slow continuous administration method. A total of 166 patients with severe hypernatremia will be enrolled and randomly assigned to receive either intermittent bolus or slow continuous infusion of 5% dextrose water. The participants will be divided into three groups according to age and sex and will receive 5% dextrose water for 2 days at different correction rates. Serum sodium will be measured every 3 h from the beginning to 6 h, followed by every 6 h until 48 h. In addition, urine sodium and potassium levels will be measured at baseline and 24 h. The PP (Per Protocol) analysis will be applied to enrolled participants who is infused with 75-125% of total planned volume of 5% dextrose water.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rapid intermittent bolus group | Active comparator | Drug: Dextrose 5% in waterA : males < 65 ; B : females < 65 or males ≥ 65 ; C : females ≥ 65 yrs <During the first 3 h> Primary treatment over 1h A: 5DW 8 B: 5DW 7 C: 5DW 6 mL/kg If undercorrected, Repeat the 5DW amount infused during primary treatment after 3 h <At 3-24 h> Modify protocol based on sNa at each time point (6/12/18/24 h) Check U/S ratio at 0 h * undercorrection < 0.5: repeat the amount infused during primary treatment q 3 h ≥ 0.5: repeat the amount infused during primary treatment q 6 h * target correction < 0.5: repeat the amount infused during primary treatment q 6 h ≥ 0.5: stop the infusion <At 24-48 h> Modify protocol based on sNa at each time point (30/36/42/48 h) Check U/S ratio at 24 h * undercorrection < 0.5: repeat the amount infused during primary treatment q 3 h ≥ 0.5: repeat the amount infused during primary treatment q 6 h * target correction < 0.5: repeat the amount infused during primary treatment q 6 h ≥ 0.5: stop the infusion |
| Slow continuous infusion group | Active comparator | Drug: Dextrose 5% in waterParticipants will be divided into three groups same as above <During the first 3 h> Primary treatment A: 5DW 1.8 B: 5DW 1.57 C: 5DW 1.35 mL/kg/h Modify protocol as described below based on sNa measurement at 3 h * undercorrection: maintain the infusion rate * target correction: stop the infusion <At 3-24 h> Modify protocol based on sNa measurement at each time point (6/12/18/24 h) Check U/S ratio at 0 h • undercorrection < 0.5: increase the infusion rate to twice that of the primary treatment ≥ 0.5: maintain the infusion rate • target correction < 0.5: maintain the infusion rate ≥ 0.5: stop the infusion <At 24-48 h> Modify protocol based on sNa measurement at each time point (30/36/42/48 h) Check U/S ratio at 24 h • undercorrection < 0.5: increase the infusion rate to twice that of the primary treatment ≥ 0.5: maintain the infusion rate • target correction < 0.5: maintain the infusion rate ≥ 0.5: stop the infusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who visit the emergency department and in-patients over 18 years
- Severe hypernatremia: glucose-corrected serum sodium ≥ 155 mmol/L
- Written consent
Key exclusion criteria (12 listed)
- Arterial hypotension requiring inotropes or vasopressors (systolic blood pressure < 90 mmHg and mean arterial pressure < 70 mmHg)
- Anuria or bilateral urinary outlet obstruction
- Uncontrolled diabetes mellitus (HbA1C > 9%) or glucose at baseline > 500 mg/dL or uncontrolled diabetic ketoacidosis or uncontrolled hyperosmolar hyperglycemic syndrome
- Decompensated liver cirrhosis (LC) - Known LC with ascites or diuretic use or hepatic encephalopathy or varix
- End-stage renal disease receiving renal replacement therapy
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 |
|---|---|---|
| Dextrose 5% in waterReducing the sodium concentration | Drug | Rapid intermittent bolus group, Slow continuous infusion group |
Primary outcome
efficacy : Incidence of rapid change in sNa level within 24 hours defined as follows
Time frame: up to 24 hours
Change in sNa by ≥ 6 mmol/L or Na ≤ 150 mmol/L within 24 hours All subjects will receive 5% dextrose water by rapid intermittent bolus or slow continuous infusion for 48 h, and sNa levels will be measured.
4 secondary outcomes
the 28-day survival rate
Time frame: up to 28 days
difference in sNa levels 6 hours after the initial test
Time frame: up to 6 hours
volume of 5% dextrose water infused during 48 hours
Time frame: up to 48 hours
Incidence of rapid change in sNa level within 48 hours defined as follows
Time frame: up to 48 hours
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 29 Aug 2025.
- Background: PubMed 30728169Qian Q. Hypernatremia. Clin J Am Soc Nephrol. 2019 Mar 7;14(3):432-434. doi: 10.2215/CJN.12141018. Epub 2019 Feb 6. No abstract available.
- Background: PubMed 30948456Chauhan K, Pattharanitima P, Patel N, Duffy A, Saha A, Chaudhary K, Debnath N, Van Vleck T, Chan L, Nadkarni GN, Coca SG. Rate of Correction of Hypernatremia and Health Outcomes in Critically Ill Patients. Clin J Am Soc Nephrol. 2019 May 7;14(5):656-663. doi: 10.2215/CJN.10640918. Epub 2019 Apr 4.
- Background: PubMed 10225241Hillier TA, Abbott RD, Barrett EJ. Hyponatremia: evaluating the correction factor for hyperglycemia. Am J Med. 1999 Apr;106(4):399-403. doi: 10.1016/s0002-9343(99)00055-8.
- Background: PubMed 10816188Adrogue HJ, Madias NE. Hypernatremia. N Engl J Med. 2000 May 18;342(20):1493-9. doi: 10.1056/NEJM200005183422006. No abstract available.
- Background: PubMed 31064771Sterns RH. Evidence for Managing Hypernatremia: Is It Just Hyponatremia in Reverse? Clin J Am Soc Nephrol. 2019 May 7;14(5):645-647. doi: 10.2215/CJN.02950319. Epub 2019 Apr 4. No abstract available.
- Background: PubMed 28669048Cabassi A, Tedeschi S. Severity of community acquired hypernatremia is an independent predictor of mortality: a matter of water balance and rate of correction. Intern Emerg Med. 2017 Oct;12(7):909-911. doi: 10.1007/s11739-017-1693-x. Epub 2017 Jul 1. No abstract available.
- Background: PubMed 22762930Lindner G, Funk GC. Hypernatremia in critically ill patients. J Crit Care. 2013 Apr;28(2):216.e11-20. doi: 10.1016/j.jcrc.2012.05.001. Epub 2012 Jul 2.
- Background: PubMed 24559470Bataille S, Baralla C, Torro D, Buffat C, Berland Y, Alazia M, Loundou A, Michelet P, Vacher-Coponat H. Undercorrection of hypernatremia is frequent and associated with mortality. BMC Nephrol. 2014 Feb 21;15:37. doi: 10.1186/1471-2369-15-37.
- Background: PubMed 21358313Alshayeb HM, Showkat A, Babar F, Mangold T, Wall BM. Severe hypernatremia correction rate and mortality in hospitalized patients. Am J Med Sci. 2011 May;341(5):356-60. doi: 10.1097/MAJ.0b013e31820a3a90.
- Background: PubMed 12897339Sterns RH, Silver SM. Salt and water: read the package insert. QJM. 2003 Aug;96(8):549-52. doi: 10.1093/qjmed/hcg102. No abstract available.
- Background: PubMed 24569125Spasovski G, Vanholder R, Allolio B, Annane D, Ball S, Bichet D, Decaux G, Fenske W, Hoorn EJ, Ichai C, Joannidis M, Soupart A, Zietse R, Haller M, van der Veer S, Van Biesen W, Nagler E; Hyponatraemia Guideline Development Group. Clinical practice guideline on diagnosis and treatment of hyponatraemia. Eur J Endocrinol. 2014 Feb 25;170(3):G1-47. doi: 10.1530/EJE-13-1020. Print 2014 Mar.
- 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.
Sejoong Kim, PhD study director
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dextrose 5% in water in people with Hypernatremia, run by Seoul National University Hospital at 1 site in South Korea.
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 3 inclusion and 12 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 29 Aug 2025. 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 South Korea. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
efficacy : Incidence of rapid change in sNa level within 24 hours defined as follows (time frame: up to 24 hours). 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 NCT04949139, which also lists 11 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 29 Aug 2025.