NCT06425289尚未招募不适用
Macrohemodynamic Impact of Fluid Removal With Net Ultrafiltration in Patients With Continuous Renal Replacement Therapy: A Monocentric Ancillary Study of the EarlyDry Randomized Controlled Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Area under the curve of a low cardiac index
研究概览
简要总结
Macrohemodynamic impact of fluid removal with net ultrafiltration in patients with continuous renal replacement therapy. A monocentric ancillary study of the EarlyDry randomized controlled trial.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute kidney injury treated by continuous renal replacement therapy in ICU less than 7 days,
- •At least 1 organ failure during ICU in addition to AKI (mechanical ventilation or vasopressors administration>12 hours),
- •Cumulative UF net less than 1000ml before inclusion,
- •Norepinephrine < 0,5 µg/kg/min,
- •Absence of hypoperfusion signs,
- •Fluid overload defined as follows: fluid overload > 5% of base weight (based on cumulative fluid balance or a weight gain) and/or peripheral edema (AKIKI edema scale > 2).
排除标准
- •Chronic renal failure hemodialyzed before admission to the ICU,
- •Mechanical circulatory support (ECMO, LVAD),
- •Pregnant, child -bearing age or lactating women,
- •Stroke less than 30 days,
- •Intestinal ischemia less than 7 days documented non-operated,
- •Interventional study participation or exclusion period on going,
- •Guardianship, curatorship or safeguard of justice,
- •Absence of signature of free and informed consent by the patient and/or relative,
- •Patients not affiliated to a social security scheme or beneficiaries of a similar scheme
- •Absence of transpulmonary thermodilution monitoring
结局指标
主要结局
Area under the curve of a low cardiac index
时间窗: Every 6 hours between day 0 to day 5 (intervention period)
Area under the curve of a cardiac index \< 2.4 L/min/m2 (L/min/m2.hr), determined by transpulmonary thermodilution every 6 hours, with three boli of cold saline in the superior vena cava territory.
次要结局
未报告次要终点
研究者
研究点 (1)
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