magnesium chloride hexahydrate; potassium chloride; sodium chloride; sodium acetate trihydrate; sodium gluconate for Critical illness

Inclusion criteria

• {"criterion_text":"- At least 18 years of age"}
• {"criterion_text":"- Patients who are admitted to the ICU for medical or surgical emergencies, including complications of elective surgery"}
• {"criterion_text":"- The treating physician expects the patient will still require ICU care in two days, indicating a severe or complex condition at enrollment"}
• {"criterion_text":"- 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"}

Exclusion criteria

• {"criterion_text":"- 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."}
• {"criterion_text":"- Hyponatremia below 131 mmol/L at admission"}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Patient’s death is deemed imminent and inevitable, admission for palliative care or admission solely for organ donation"}
• {"criterion_text":"- Patient receiving chronic renal replacement therapy"}
• {"criterion_text":"- Patients referred after a stay of more than 24 hours in another ICU"}
• {"criterion_text":"- Patients randomized in CRUSADERS before"}
• {"criterion_text":"- Patient is co-enrolled in an unapproved concomitant ICU-trial or in any trial with an intervention that affects fluid administration or fluid balance"}

Primary endpoints

• {"endpoint_text":"- The primary endpoint of the CRUSADERS study is Days alive and without life support (DAWOLS) at 90 days after ICU admission.","definition_or_measurement_approach":"Days alive and without life support (DAWOLS) measured at 90 days after ICU admission."}

Secondary endpoints

• {"endpoint_text":"- Occurrence of moderate and severe hyponatremia","definition_or_measurement_approach":""}
• {"endpoint_text":"- Occurrence of moderate and severe hypernatremia","definition_or_measurement_approach":""}
• {"endpoint_text":"- Occurrence of moderate and severe hyperchloremia","definition_or_measurement_approach":""}
• {"endpoint_text":"- Fluid retention and diuretic use","definition_or_measurement_approach":""}
• {"endpoint_text":"- Occurrence of hyperglycemia and hypoglycemia","definition_or_measurement_approach":""}
• {"endpoint_text":"- Acute kidney injury","definition_or_measurement_approach":""}
• {"endpoint_text":"- Mechanical ventilation","definition_or_measurement_approach":""}
• {"endpoint_text":"- Mortality and length of stay","definition_or_measurement_approach":""}
• {"endpoint_text":"- Daily and cumulative sodium, chloride and glucose administration: daily and cumulative sodium, chloride and glucose administration from all sources except for non-study fluid creep and oral intake. For blood products, estimated values of sodium and chloride content are used.","definition_or_measurement_approach":"Daily and cumulative administration measured from all sources except non-study fluid creep and oral intake; estimated values used for blood products."}
• {"endpoint_text":"- Fluid balance: Daily and cumulative fluid balance on ICU days, excluding (calculations of) insensible losses. From the moment RRT or IV loop diuretics are started, fluid balance data are analyzed separately from the patients without those interventions. Fluid balance assessments are discontinued from the ICU day when the urinary catheter is removed or bladder irrigation is initiated.","definition_or_measurement_approach":"Daily and cumulative fluid balance on ICU days excluding insensible losses; separate analyses after RRT or IV loop diuretics start; assessments discontinued when urinary catheter removed or bladder irrigation initiated."}

Belgium

Earliest CTIS Part Ii Submission Date

28-05-2025

Latest Decision Or Authorization Date

13-06-2025

Processing Time Days

16

Number Of Sites

4

Number Of Participants

640

Primary sponsor

Full Name

Universitair Ziekenhuis Antwerpen

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Belgium