Forced Fluid Removal vs. Usual Intensive Care in High-risk Acute Kidney Injury With Severe Fluid Overload - A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 21
- 试验地点
- 3
- 主要终点
- Cumulative fluid balance
研究概览
简要总结
The objective of this pilot trial is to assess the feasibility of forced fluid removal in patients admitted to the intensive care unit (ICU) with high-risk AKI and severe fluid overload. The intervention will use furosemide infusion and/or continuous renal replacement therapy (CRRT) to achieve and maintain a neutral cumulative fluid balance. The intervention will be compared to standard of care as reflected in the kidney disease improving global outcome (KDIGO) guidelines.
详细描述
Acute kidney injury (AKI) is a common and serious complication in patients admitted to ICU. A core element of critical care is resuscitation with crystalloid solutions. In many cases fluid accumulates and patients become fluid overloaded (positive fluid balance > 10% of bodyweight). This is especially true in patients with AKI, since they often have impaired ability to excrete salt and water. Most observational suggests harm with increased positive fluid balance.
Objectives: To assess feasibility of forced fluid removal with diuretics and/or CRRT in ICU patients with AKI and severe fluid overload, compared to current clinical practice.
Design: Multicentre, parallel group, randomized, assessor blinded pilot-trial with adequate generation of allocation sequence, and allocation concealment.
Trial Size: The pilot study is planned to include 50 patients. Inclusion is expected to start in August 2015.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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 of age
- •Acute Kidney Injury defined according to the KDIGO criteria
- •Renal Recovery Score ≤ 60%. (Calculated using www.renal-recovery-score.com)
- •Fluid overload defined as a positive fluid balance ≥ 10% of ideal body weight.
- •Able to undergo randomization within 12 hours of fulfilling other inclusion criteria
排除标准
- •Known pre-hospitalization advanced chronic kidney disease. (eGFR < 30 mL/minute/1.73 m2 or chronic RRT.)
- •Severe hypoxic respiratory failure (use of invasive ventilation and FiO2 > 80% and PEEP > 10 cm H2O)
- •Severe burn injury (≥ 10% TBSA)
- •Severe hypo- or hyper- natremia (< 120 or > 155 mmol/l)
- •Hepatic coma
- •Mentally disabled undergoing forced treatment
- •Pregnancy/breast feeding
- •Lack of commitment for on-going life support including RRT
- •Lack of informed consent
研究组 & 干预措施
Forced Fluid Removal
The experimental intervention is guided by a therapeutic goal of average negative fluid balance ≥ 1 ml/kg/h and safety variables indicating inadequate circulation (lactate ≥ 4, MAP < 50 or mottling beyond the edge of kneecaps).
The effect of fluid removal is evaluated three times daily (06:00. 14:00 and 22:00), while the safety variables are evaluated continuously. Resuscitation is started if one or more signs of inadequate circulation is present.
The first choice for fluid removal is diuretic therapy with furosemide, which is continued for a minimum of 8 hours. If the therapeutic goal (negative fluid balance ≥ 1 ml/kg/h) is not achieved and/or maintained by furosemide alone, then fluid removal with continuous renal replacement therapy (CRRT) is initiated.
干预措施: Furosemide (Furix) (Drug)
Forced Fluid Removal
The experimental intervention is guided by a therapeutic goal of average negative fluid balance ≥ 1 ml/kg/h and safety variables indicating inadequate circulation (lactate ≥ 4, MAP < 50 or mottling beyond the edge of kneecaps).
The effect of fluid removal is evaluated three times daily (06:00. 14:00 and 22:00), while the safety variables are evaluated continuously. Resuscitation is started if one or more signs of inadequate circulation is present.
The first choice for fluid removal is diuretic therapy with furosemide, which is continued for a minimum of 8 hours. If the therapeutic goal (negative fluid balance ≥ 1 ml/kg/h) is not achieved and/or maintained by furosemide alone, then fluid removal with continuous renal replacement therapy (CRRT) is initiated.
干预措施: Continuous renal replacement therapy (CRRT) (Other)
Forced Fluid Removal
The experimental intervention is guided by a therapeutic goal of average negative fluid balance ≥ 1 ml/kg/h and safety variables indicating inadequate circulation (lactate ≥ 4, MAP < 50 or mottling beyond the edge of kneecaps).
The effect of fluid removal is evaluated three times daily (06:00. 14:00 and 22:00), while the safety variables are evaluated continuously. Resuscitation is started if one or more signs of inadequate circulation is present.
The first choice for fluid removal is diuretic therapy with furosemide, which is continued for a minimum of 8 hours. If the therapeutic goal (negative fluid balance ≥ 1 ml/kg/h) is not achieved and/or maintained by furosemide alone, then fluid removal with continuous renal replacement therapy (CRRT) is initiated.
干预措施: Resuscitation (Other)
Usual Care
Usual Care at the discretion of the treating clinicians, except for the initiation of renal replacement therapy (RRT).
干预措施: Usual Care (Other)
结局指标
主要结局
Cumulative fluid balance
时间窗: 5 days
Calculated as the sum of daily intake - daily output, as registered on the daily ICU observation charts.
次要结局
- Major protocol violations(ICU stay expected average of 10 days)
- Time to neutral cumulative fluid balance(90 days)
- Accumulated serious adverse reactions(90 days)
- Cumulative fluid balance(ICU stay expected average of 10 days)
- Mean daily fluid balance(ICU stay expected average of 10 days)