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ICU fluid overload: could cutting salt save lives?

NCT ID NCT07189091

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether using lower-salt intravenous fluids in ICU patients reduces the number of days they need life support like ventilators or dialysis. Researchers will compare a salt-free glucose solution for medication dilution and a low-salt maintenance fluid against the usual higher-salt fluids. The trial enrolls 640 critically ill adults expected to stay in the ICU for several days.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
lower-salt intravenous fluids (glucose 5% and NaCl 0.3% in glucose 3.3%)
What this could lead to
If it works, this could lead to a simple change in ICU fluid practices that helps patients recover faster and spend fewer days on life support.
What could go wrong
This is a single-center trial, so results may not apply everywhere. The benefit may be small or none, and lower-salt fluids could cause electrolyte imbalances in some patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 640 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Jul 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria 1. At least 18 years of age 2. Patients who are admitted to the ICU for medical or surgical emergencies, including complications of elective surgery 3. The treating physician expects the patient will still require ICU care in two days, indicating a severe or complex condition at enrollment 4. The patient is expected to receive at least 300 mL of fluid creep or at least 1 liter of maintenance fluid according to study-arm during the first 24h after inclusion Exclusion Criteria: 1. A contraindication to hypotonic fluids due to risk of brain edema (including traumatic brain injury, major stroke, intracranial/subarachnoid hemorrhage, meningoencephalitis, intracranial malignancies…), with the timing and clinical judgment left at the discretion of the treating physician. 2. Hyponatremia below 131 mmol/L at admission 3. Admission solely for treatment of fluid accumulation due to cardiac decompensation, without other acute medical conditions requiring ICU-level care. Note: Patients with heart failure as a comorbidity, those on chronic diuretic therapy, or presenting with edema/bilateral lung infiltrates due to other conditions (e.g., sepsis, pneumonia) are not excluded. 4. Patient's death is deemed imminent and inevitable, admission for palliative care or admission solely for organ donation 5. Patient receiving chronic renal replacement therapy 6. Patients referred after a stay of more than 24 hours in another ICU 7. Patients randomized in CRUSADERS before 8. Patient is co-enrolled in an unapproved concomitant ICU-trial or in any trial with an intervention that affects fluid administration or fluid balance Additional exclusion criteria for the SALADIN nested substudy 1. Patients expected to require renal replacement therapy within 24 hours 2. Increased insensible fluid losses: burns, extensive wounds or skin defects or massive diarrhea,… 3. Patients without a urine catheter 4. Patients expected to require bladder irrigation within 24 hours 5. Patients on chronic treatment with loop or thiazide diuretics (including combination preparations)

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Conditions

The condition(s) this trial relates to.

acute kidney injury Critical Illness Hyponatremia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    4 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Antwerp University Hopsital (UZA)

    NOT_YET_RECRUITING

    Edegem, 2650, Belgium

  • ZAS Cadix

    RECRUITING

    Antwerp, 2030, Belgium

  • ZAS Middelheim

    NOT_YET_RECRUITING

    Antwerp, 2020, Belgium

  • ZAS Paflijn

    NOT_YET_RECRUITING

    Merksem, 2170, Belgium

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