2025-520744-14-00招募中4 期
CReep and maintenance flUid Salt ADministration rEduction in cRitically ill adultS - (CRUSADERS)
Universitair Ziekenhuis Antwerpen2 个研究点 分布在 1 个国家目标入组 640 人开始时间: 2025年6月13日最近更新:
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 640
- 试验地点
- 2
- 主要终点
- The primary endpoint of the CRUSADERS study is Days alive and without life support (DAWOLS) at 90 days after ICU admission.
研究概览
简要总结
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.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
The primary endpoint of the CRUSADERS study is Days alive and without life support (DAWOLS) at 90 days after ICU admission.
The primary endpoint of the CRUSADERS study is Days alive and without life support (DAWOLS) at 90 days after ICU admission.
次要结局
- Mortality and length of stay
- Occurrence of moderate and severe hyponatremia
- Occurrence of moderate and severe hypernatremia
- Occurrence of moderate and severe hyperchloremia
- Fluid retention and diuretic use
- Occurrence of hyperglycemia and hypoglycemia
- Acute kidney injury
- Mechanical ventilation
- 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.
- 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.
研究者
Niels Van Regenmortel
Scientific
Universitair Ziekenhuis Antwerpen
研究点 (2)
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