Efficacy and Safety of Rapid Intermittent Correction Compared With Slow Continuous Correction in … (NCT04949139) | Clinical Trial Compass
CompletedPhase 4
Efficacy and Safety of Rapid Intermittent Correction Compared With Slow Continuous Correction in Patients With Severe Hypernatremia
South Korea178 participantsStarted 2021-05-01
Plain-language 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).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Exclusion criteria
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial compared two methods for correcting severely high sodium levels — a rapid intermittent approach versus a slow continuous one — can you explain what each method would actually look like for me in practice, and which approach you currently use?
2Since this was a Phase 4 trial, meaning the treatments being compared are already approved and in use, does that mean there's more known about the safety of both correction methods than there would be in an earlier-phase study?
3The trial specifically measured how often sodium levels dropped too quickly within 24 hours — why does the speed of sodium correction matter so much, and what risks am I facing if my sodium comes down too fast or too slowly?
4Now that this trial is completed, have any results been published that might help guide which correction method is safer or more effective for someone with my specific situation?
5Are there factors in my individual case — like the cause of my high sodium, how long I've had it, or other health conditions — that would make one correction approach clearly better for me than the other?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
efficacy : Incidence of rapid change in sNa level within 24 hours defined as follows