UnknownNot Applicable

Plasma Sodium and Sodium Administration in the ICU

Sweden200 participantsStarted 2023-09-04

Plain-language summary

Patients in the Intensive Care Unit often present with low levels of plasma sodium and are therefore often administered high amounts of sodium, both as an additive to intravenous glucose solutions and as a constituent of various drugs and infusion fluids. Recent findings question the benefit of these large quantities of sodium and raise the question whether the individual physician takes the total sodium administration into account when sodium additives are prescribed. It can also be suspected that sodium prescription differs significantly between physicians.

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: * Adult * Documented length of stay at the Central Intensive Care Unit (CIVA) at the University Hospital of Linköping of seven (7) days minimum. * The patient has been discharged from the ICU. * Body Mass Index (BMI) between 18.0 and 48.0 kg/m2 at admission. Exclusion Criteria: * The patient has previously been included in the study in connection with another ICU-admission. * The patient has a severe hyponatremia (\<129 mmol/L) upon arrival to the ICU. * The patient has a severe hypernatremia (\>149 mmol/L) upon arrival to the ICU. * The patient is severely hyperosmolar (\>330 mmol/L) upon arrival to the ICU. * The patient is severely hyperglycemic (\>30 mmol/L) upon arrival to the ICU. * The patient has an elevated serum urea (\>30 mmol/L) upon arrival to the ICU. * The patient receives any dialysis treatment during the observation time. * The patient is suspected to have an elevated intracranial pressure during the observation time or is suspected to have other intracranial pathology that is likely to affect sodium homeostasis * The patient has an intoxication with toxic alcohols as a primary diagnosis.

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 seems to be studying how sodium levels are managed in ICU patients — if I or my family member ends up in the ICU, how does monitoring and adjusting sodium levels fit into the standard care plan, and is this kind of research relevant to my situation?
2Since this study is listed as 'unknown' recruitment status, can you find out whether it's still actively enrolling patients, and whether it would even be an option to consider?
3The trial is measuring how closely the sodium a doctor prescribes matches what a patient actually receives from all sources in the ICU — why does that gap matter, and could it affect outcomes for someone with my condition?
4This appears to be an observational or measurement study rather than a treatment trial — does that mean it wouldn't change the care I receive, and is there any risk to me from being part of it?
5Given that this study involves patients with hypernatremia or hyponatremia in critical illness, and my own sodium or health situation, is there a standard treatment approach already in place that I should understand before considering whether a study like this is relevant to me?

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

The coefficient of determination (r2) between the amount prescribed sodium additive and the amount of sodium the patient is expected to receive through other routes.

Timeframe: During admission to ICU for a maximum of 28 days

Trial details

NCT IDNCT06037928

SponsorUniversity Hospital, Linkoeping

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-11-30

Contact for this trial

Hans Bahlmann, MD, PhD

+46739312281 hans.bahlmann@regionostergotland.se

View on ClinicalTrials.gov More Hypernatremia trials