Early Deresuscitation Strategy Driven by Tissue Perfusion in Renal Replacement Therapy in Patients With Acute Renal Failure in Intensive Care Unit. A Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 23
- 主要终点
- Number of organ replacement free-days
研究概览
简要总结
In Intensive Care Unit (ICU) patients with acute kidney injury (AKI) and treated with renal replacement therapy (RRT) often present a fluid overload which is associated with morbidity (mechanical ventilation duration increase, kidney recovery decrease) and mortality.
Patients' prognostic could be improved by correcting the fluid overload with net ultrafiltration (UFnet) however it may lead to harmful iatrogenic hypovolemia responsible of deleterious ischemic lesions.
In usual practice, UF net prescription are variable and there are different international recommendations. Some observational studies suggest that using a UFnet between 1 et 1.75 mL/kg/h in fluid overloaded patient decrease mortality.
Fluid overload increases morbidity and mortality, particularly in RRT. Studies without RRT argue for an efficacy of management by decreasing the fluid overload .Cohort studies suggest to use a moderate UFnet instead of a low UFnet. Some data from studies on early versus late RRT that relate the fluid balance or correct the fluid overload during the early strategy argue for a beneficial effect of an early deresuscitation strategy
Consequently, the impact of a moderate UFnet (to decrease the fluid overload) compared to a low UFnet (to stabilize the fluid overload) in a randomized interventional study could be assessed.
The study hypothesis is that :
an early fluid overload deresuscitation protocol with a high UFnet (2 ml/kg/h) targeting both the negativation of cumulated fluid balance to reach a dry weight and the maintenance of tissue perfusion.
Compared to
fluid overload deresuscitation protocol with a low UFnet (between 0 and 1 ml/kg/h) to reach a stabilization of cumulated fluid balance without monitoring the tissue perfusion.
could improve overall, renal, hemodynamic and respiratory prognosis in fluid overloaded patients with renal replacement therapy in ICU
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
- Single (Participant)
盲法说明
For this protocol, the double blind is impossible to set up. Clinicians in charge of patients and implementing the depletion strategy cannot be blinded.
The patients will be blinded, they will not be aware of strategy applied. The medical staff will ensure that no information about the intervention is given to the patient.
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 oxygen therapy or vascular filling > 1000ml or vasopressor exposure > 12 hours),
- •Weight loss of less than 3% since starting a net UF or Cumulative UF net less than 2000ml before inclusion,
- •Norepinephrine < 0,5 µg/kg/min,
- •Absence of hypoperfusion signs defined by the presence of at least 2 out of 4 criteria:
- •TRC > 3s at the finger
- •Marbrure score > 2
- •Lactate > 2 mmol/L
- •ScVO2< 60%,
- •Fluid overload defined as follows :
- •fluid overload > 5% of base weight (based on cumulative fluid balance or a weight gain) and/or
- •Obvious oedema of the lumbar region or flanks (oedema > 1cm bucket depth).
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 based on the combination of central neurological symptoms (aphasia, hemiplegia, hemiparesis) associated with compatible brain imaging, less than 30 days,
- •Intestinal ischemia less than 7 days documented non-operated,
- •Interventional study participation or exclusion period on going,that may interfere with the present study
- •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
研究组 & 干预措施
Corrective strategy
In the experimental group, all patients will have a UFnet settled (2 ml/kg/h ) in order to reach the patient baseline body weight.
干预措施: Fluid balance negativation (Procedure)
Stabilizing strategy
In the control group, all patients will have a UFnet 2 ml settled (0 to 1 ml/kg/h) in order to stabilize the patient body weight.
干预措施: Body weight Stabilization (Procedure)
结局指标
主要结局
Number of organ replacement free-days
时间窗: Day 30
Number of organ replacement free-days, i.e, number of renal replacement therapy-free days, number of vasopressor-free days, number of ventilator-free day. Number of days between 2 same type organ replacement interruption is not counted. In case of death before 30 days, number of days is censored to 0.
次要结局
- Mortality decrease(30 days)
- Incidence of strokes(From Day 0 to Day 30)
- Renal recovery assessment(Day 30)
- Number of renal replacement therapy-free days increase(Day 30)
- Incidence of arrhythmias and cardiac conduction disorders in both group(From Day 0 up to Day 5)
- Incidence of intestinal ischemia in both group(From Day 0 to Day 30)
- Incidence of delirium(Between Day 0 and Day 5)
- Number of ventilator-free day increase(Day 30)
- Number of vasopressor-free day increase(Day 30)
- Duration of intensive care unit stay(Up to Day 30)
- SOFA score evolution(From Day 0 up to Day 5)