Optimization of Fluid Balance Guided by Bioelectrical Impedance Analysis in Patients Undergoing Continuous Renal Replacement Therapy in Critical Care
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- comparison of TBW between both groups
研究概览
简要总结
In critical care, hemodynamic instability often requires volume expansion to restore tissue perfusion, increasing fluid balance and TBW, factors associated with higher mortality. Excess fluid leads to organ dysfunction due to venous congestion, making fluid removal crucial. When diuretics fail, RRT, typically through continuous renal replacement therapy (CRRT), is recommended. However, prescribing the correct level of UF is challenging; insufficient UF can worsen edema, while excessive UF risks hemodynamic instability. This pilot, single-center, prospective, interventional, randomized, controlled, open-label study includes two parallel groups: a standard group with UF prescribed by the physician based on clinical and hemodynamic status and an experimental group with UF guided by the extracellular to total body water (ECW/TBWat) ratio measured by BIA. The aim is to determine if ECW/TBW-guided UF improves fluid and TBW reduction over a 72-hour RRT period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
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
- •Age > 18 years
- •The patient was hospitalized in the intensive care unit of Amiens-Picardie University Hospital.
- •Patient with an increase in fluid balance (TBW > 5%)
- •Patient receiving continuous veno-venous hemofiltration (CVVH) on a PrismaFlexR or PrisMaxR machine, initiated due to oliguria, potassium level > 6.5 mmol/L, urea level > 25 mmol/L, or creatinine > 300 µmol/L and severe metabolic acidosis (pH < 7.2).
- •Hemodynamically stable patient with a mean arterial pressure (MAP) > 65 mmHg for more than 4 hours with norepinephrine.
- •Signed consent to participate in the study by the patient or, if unconscious, their legal representative/next of kin.
排除标准
- •Invalid BIA measurements
- •Internal device powered by an electrical current (pacemaker, implantable cardioverter-defibrillator, neurostimulator)
- •Cardiac arrhythmia (atrial fibrillation, atrial flutter) present at the inclusion
- •Chronic dialysis patient
- •Moribund patient
- •The patient is on extracorporeal mechanical support
- •Hemorrhagic shock
- •Pregnant woman
- •Patient under guardianship or conservators.
研究组 & 干预措施
Free UF Prescription
Free UF Prescription :
The UF (ml/h) is prescribed by the responsible physician based on the patient's clinical, congestive, and hemodynamic status. The physician can implement the UF whenever necessary based on the patient's hemodynamic condition.
干预措施: continuous renal replacement therapy (CRRT) (Procedure)
UF Prescription Guided by the ECW/TBWat Ratio
Experimental Group - UF Prescription Guided by the ECW/TBWat Ratio :
- In the experimental group, the patient will receive a prescription for UF guided by the ECW/TBWat ratio. The goal is to achieve an ECW/TBWat ratio of less than 0.400 by the end of the 72-hour RRT session.
- To meet this objective, the physician must measure the ECW/TBWat ratio each time the UF is adjusted. If the patient's ECW/TBWat ratio is less than 0.400 at the measurement time, the goal is to maintain it below 0.400 during the RRT session.
- To calculate the ECW/TBWATratio, the Inbody BWA 2.0 device requires the initial TBW, which will be measured by the Hill-Room Acella 900 bed (Hill-Room, Batesville, USA).
- The ratio is calculated by the Inbody BWA 2.0 and is based on the average of 3 consecutive measurements.
- The physician determines the prescription for adjusting the UF (ml/h) based on the patient's hemodynamic and clinical condition during the RRT session.
干预措施: Free UF Prescription (Other)
结局指标
主要结局
comparison of TBW between both groups
时间窗: at 72 hours
To assess the impact of UF prescription guided by the ECW/TBWat ratio on weight loss, a comparison of TBW (∆TBW) between the two groups will be conducted. The ∆TBW is the difference between the initial TBW at H0 and the TBW at H72.
次要结局
- Measurement of the net UF rate(at 72 hours)
- Variation of cumulative net UF(at 72 hours)
- Measurement of the ECW/TBWATratio and its association with the VeXUS score(at 72 hours)
- Number of arrhythmias with hemodynamic instability(at 72 hours)
- Duration of mechanical ventilation(at day 30)
- Measurement of the ECW/TBWAT ratio(72 hours)
- number of filters used in both groups(at 72 hours)
- duration of use for each filter in both groups(at 72 hours)
- Measurement of serum phosphate(at 72 hours)
- Cumulative dose of norepinephrine administration(at 72 hours)
- Length of stay at the hospital(at day 30)
- Cumulative volume of crystalloid administration(at 72 hours)
- Number of hypotensive episodes during dialysis(at 72 hours)
- Number of arrhythmias in both groups(at 72 hours)
- Cumulative volume of colloid administration(at 72 hours)
- Duration of norepinephrine administration(at 72 hours)
- Measurement of serum potassium(at 72 hours)
- 30-day mortality(at day 30)
- Length of stay in intensive care(at day 30)
- Measurement of the ECW/TBWATratio and its association with the VeXUS score(day 0)
- Measurement of the ECW/TBWAT ratio(day 0)
- number of filters used in both groups(at 24 hours)
- number of filters used in both groups(at 48 hours)
- duration of use for each filter in both groups(at 24 hours)
- duration of use for each filter in both groups(at 48 hours)
- Number of hypotensive episodes during dialysis(at 24 hours)
- Number of hypotensive episodes during dialysis(at 48 hours)
- Number of arrhythmias in both groups(at 24 hours)
- Number of arrhythmias in both groups(at 48 hours)
- Number of arrhythmias with hemodynamic instability(at 24 hours)
- Number of arrhythmias with hemodynamic instability(at 48 hours)
- Measurement of serum potassium(at 24 hours)
- Measurement of serum potassium(at 48 hours)
- Measurement of serum phosphate(at 24 hours)
- Measurement of serum phosphate(at 48 hours)