A Phase 4 interventional study of Dextrose 5% in water in Hypernatremia, sponsored by Seoul National University Hospital. Completed at 1 site in South Korea. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-29.
Sponsored by Seoul National University Hospital · Phase 4, Interventional, and Treatment
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).
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.
49 studies on the registry are indexed under Hypernatremia; 8 are open to participants now.
This study's enrollment of 178 is above the median of 64 across 32 interventional studies indexed under Hypernatremia.
Browse Hypernatremia studies →Seoul National University Hospital is the lead sponsor of 1,900 studies on the registry; 274 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients with the following conditions within 30 days prior to randomization:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Drug: Dextrose 5% in water
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
Drug: Dextrose 5% in water
Reducing the sodium concentration
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.
Time frame: up to 24 hours
the 28-day survival rate
survival rate
Time frame: up to 28 days
difference in sNa levels 6 hours after the initial test
Gap of sodium level between 6 hours and initial level
Time frame: up to 6 hours
volume of 5% dextrose water infused during 48 hours
Volume
Time frame: 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
Time frame: up to 48 hours
Target correction rate
Change in Na by ≥ 6 mmol/L and \< 12 mmol/L from the initial level or Na ≤ 150 mmol/L within 24 hours Change in Na by ≥ 12 mmol/L and \< 24 mmol/L from the initial level or Na ≤ 150 mmol/L within 48 hours
Time frame: up to 48 hours
Incidence of undercorrection:
sNa \< 6 mmol/L within 3/6/12/24 hours sNa \< 12 mmol/L within 48 h
Time frame: up to 48 hours
Length of hospital stay
Length of hospital stay
Time frame: up to 8 weeks
Number of uses of desmopressin
number of uses of demopressin
Time frame: up to 48 hours
Incidence of overcorrection
Na \> 12 mmol/L within 24 h or \> 24 mmol/L within 48 h at any given period
Time frame: up to 48 hours
Incidence of cerebral edema documented via brain CT at 48 hours in patients with overcorrection
incidence of cerebral edema
Time frame: up to 48 hours
Incidence of osmotic demyelinating syndrome confirmed by ICD-10 code or MRI
incidence of ODS
Time frame: up to 48 hours
Glasgow coma scale at pretreatment, 6 hours, 24 hours, and 48 hours
Glasgow coma scale can range from 3 (completely unresponsive) to 15 (responsive).
Time frame: up to 48 hours
In-hospital mortality
mortality rate
Time frame: up to 28 days
Incidence of administrated intravenous volume of ≥ 3 L/day, except for fluids administrated according to the protocol
incidence of adminitrated intravenous volume of ≥ 3 L/day
Time frame: up to 48 hours
Plan to share: No
This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Glucose
Seoul National University Hospital →