Prospective Analysis Into Development of Hypernatremia in Critically Ill Patients (NCT05085223) | Clinical Trial Compass
UnknownNot Applicable
Prospective Analysis Into Development of Hypernatremia in Critically Ill Patients
Netherlands1,500 participantsStarted 2021-10
Plain-language summary
Hypernatremia is frequently encountered in patients admitted to the Intensive Care Unit (ICU) and associated with increased mortality and length of stay. Previous studies focused on predictors in the development and recovery of hypernatremia by including amount and types of administered medication, fluid balance, laboratory results and changes in vital signs. However, data of larger populations or data on infusion rates, fluid and sodium balance or renal replacement therapy is lacking. The predecessor of this study was the HYPNIC trial which found that increased sodium load en decreased sodium excretion preceded hypernatremia development, but was lacking information on the first 48 hours, fluid balances were manually collected before a new data collection system was introduced and was suffering from substantial amounts of missing data and small population for trend analysis.
This study aims to provide better insight in the development and recovery of hypernatremia while paying attention to the limitations from the HYPNIC trial.
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.
Inclusion Criteria:
* Admitted to Intensive Care Unit
* Age 18 years or older
Exclusion Criteria:
* Age 17 years or younger
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 is studying how hypernatremia develops in critically ill patients — if I'm already dealing with dangerously high sodium levels in the ICU, could participating in this observational study affect my current treatment plan in any way?
2Since this is listed as a prospective analysis rather than a treatment trial, does that mean it's mainly collecting data and observing patients rather than testing a new drug or intervention, and what would that actually mean for my day-to-day care?
3The recruitment status for this trial is listed as unknown — can you find out whether this study is still actively enrolling patients at this hospital, or whether it has been paused or completed?
4Given that this study focuses on critically ill patients who develop hypernatremia, what information would my medical team be gathering about me, and how would that data be used to potentially help future patients in similar situations?
5Are there standard treatments or monitoring protocols for hypernatremia in critical illness that I should be receiving regardless of whether I participate in this study, and how would you compare those to what this trial involves??
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.