Feasibility of Slow Continuous Ultrafiltration With Regional Anticoagulation for Deresuscitation in Critically Ill Patients Though Standard Central or Peripheral Venous Access.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Number of patients with daily fluid balance within 500 mL of prescribed target
研究概览
简要总结
To determine the feasibility and safety of deresuscitation using slow continuous ultrafiltration with regional citrate anticoagulation and peripheral or standard central venous access.
详细描述
Fluid deresuscitation has been shown to have favourable outcomes in the management of the critically ill patient. Whilst diuretic medications have previously been the mainstay of achieving this deresuscitation, the metabolic and biochemical complications associated with their use can limit their application. Mechanical ultrafiltration is another means of achieving fluid deresuscitation and has theoretical benefits over the use of intravenous diuretics. It allows a more titratable process, without the potential metabolic complications. The use of ultrafiltration has been limited by the requirement of wide bore central venous access. The SCUFFD study is a means of assessing whether ultrafiltration with regional anticoagulation can be achieved through standard central or peripheral venous access.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Adults (>18 years)
- •Evidence of fluid overload (greater than trace amount of peripheral oedema in >1 site, pulmonary oedema on chest radiograph, or positive fluid balance equivalent to >5% body weight)
- •Clinician intention to target a negative fluid balance
- •Expected to remain in a critical care setting beyond the next calendar day
排除标准
- •Anticipated unavailability of suitable vascular access
- •Lack of commitment to full support
- •Receiving or imminently planned to receive renal replacement therapy
- •Hyponatraemia (Sodium <130mmol/L)
- •Hypernatraemia (Sodium >150mmol/L)
- •Significant metabolic alkalosis (Bicarbonate>30 and pH>7.5)
- •Significant metabolic acidosis (HCO3- <18 mmol/l and pH < 7.30)
- •Uncorrected hypokalaemia (Potassium <3.0mmol/L)
- •Liver failure (Child-Pugh Grade B or above)
- •Shock (any of: lactate >3mmol/L, extensive skin mottling, central capillary refill time>3 seconds, more than 1 vasoactive agent in use, noradrenaline dose >0.2 mcg/kg/min, use of dobutamine, adrenaline, milrinone, enoximone or levosimendan)
- •Receiving any systemic anticoagulation other than for routine venous thromboembolism prophylaxis, or dual antiplatelet therapy
- •Known pregnancy
结局指标
主要结局
Number of patients with daily fluid balance within 500 mL of prescribed target
时间窗: 5 days per patient
Assessing the feasibility of managing to achieve the target fluid balance
Number of patients with filter or circuit thrombosis requiring discontinuation of therapy
时间窗: 5 days per patient
Ensuring that the process of haemofiltration does not result in unacceptable levels of thrombotic events
Total volume of fluid removed using ultrafiltration
时间窗: 5 days per patient
Assessing the feasibility of fluid removal by ultrafiltration
Circuit lifespan
时间窗: 5 days per patient
The lifespan of each ultrafiltration circuit, to assess the feasibility of using this method as a therapeutic option
次要结局
- Number of patients developing new onset hyponatraemia(5 days per patient)
- Number of patients with a significant change in sodium(5 days per patient)
- Number of patients developing new onset hypokalaemia(5 days per patient)
- Number of patients developing metabolic alkalosis(5 days)
- Number of patients developing new onset hypernatraemia(5 days per patient)
- Number of patients developing citrate accumulation(5 days)
- Number of patients developing metabolic acidosis(5 days)