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CReep and maintenance flUid Salt ADministration rEduction in cRitically ill adultS - (CRUSADERS)
EU CTIS ID: 2025-520744-14-00
What this study is testing
We hypothesize that a strategy of reducing the sodium chloride burdens in critically ill adult patients by targeting the sodium and chloride content of fluid creep and maintenance fluids leads to a better outcome in terms of mortality and respiratory and renal organ support, compared to a regimen in which fluid creep and maintenance fluids predominantly consist of isotonic solutions.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- At least 18 years of age
- Patients who are admitted to the ICU for medical or surgical emergencies, including complications of elective surgery
- The treating physician expects the patient will still require ICU care in two days, indicating a severe or complex condition at enrollment
- The patient is expected to receive at least 300 mL of fluid creep or at least 1L of maintenance fluid according to study arm during the first 24h after inclusion
You likely can't join if
- 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.
- Hyponatremia below 131 mmol/L at admission
- 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.
- Patient’s death is deemed imminent and inevitable, admission for palliative care or admission solely for organ donation
- Patient receiving chronic renal replacement therapy
- Patients referred after a stay of more than 24 hours in another ICU
See the full eligibility criteria
- At least 18 years of age
- Patients who are admitted to the ICU for medical or surgical emergencies, including complications of elective surgery
- The treating physician expects the patient will still require ICU care in two days, indicating a severe or complex condition at enrollment
- The patient is expected to receive at least 300 mL of fluid creep or at least 1L of maintenance fluid according to study arm during the first 24h after inclusion
- 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.
- Hyponatremia below 131 mmol/L at admission
- 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.
- Patient’s death is deemed imminent and inevitable, admission for palliative care or admission solely for organ donation
- Patient receiving chronic renal replacement therapy
- Patients referred after a stay of more than 24 hours in another ICU
- Patients randomized in CRUSADERS before
- Patient is co-enrolled in an unapproved concomitant ICU-trial or in any trial with an intervention that affects fluid administration or fluid balance
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.