Comparison of Two Approved Dialysis Methods for Treatment of Metabolic or Mixed Acidosis in Critically Ill Patients With Acute Kidney Injury and Indication for Renal Replacement Therapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Hours alive with normal pH (≥ 7.35) within first 24 hours of therapy
研究概览
简要总结
The aim of the study is to investigate the effects of ADVOS® therapy in critically ill patients with acute kidney injury, necessity of renal replacement therapy and acidosis.
The investigators aim at assessing superiority of ADVOS® versus CVVHD for the primary outcome hours alive with normal pH (arterial pH ≤ 7,35) until 24 hours in a modified intention-to-treat analysis (mITT: replacement if dropped out before treatment start).
详细描述
Acute kidney injury (AKI) is frequently seen in patients treated at intensive care unit (ICU) and is associated with high morbidity and mortality. AKI occurs in more than 30% of critically ill patients. Various definitions for AKI have been used in the last decades, as a consequence reported incidence rates vary considerably from 13 to 78% in critically ill patients. AKI reflects a broad spectrum of clinical presentations, ranging from mild to se-vere injury, which may result in permanent loss of renal function. AKI is generally detected by a decrease in urine output (oliguria, anuria) and by an increase of renal serum markers (creatinine, blood-urea-nitrogen) with subsequent disorders in electrolyte homeostasis (e.g. hyperkalemia) and acid-base-regulation by means of metabolic acidosis. The AKIN criteria are well established criteria for diagnosis of AKI.
Different factors have been associated with development of AKI in critically ill patients. Age and pre-existing comorbidities are risk factors for development of AKI. Furthermore, infection and sepsis seem to be a mayor trigger for AKI. More than 50% of patients with septic shock develop AKI. Besides this radiocontrast agents, rapid progressive glomerulonephritis, rhabdomyolysis, trauma, circulatory shock, cardiac surgery, major non-cardiac surgery, nephrotoxic drugs and other causes are capable inducing AKI.
Metabolic acidosis, a frequent finding in AKI, is diagnosed when serum pH is reduced (pH < 7,35) and serum bicarbonate levels are abnormally low. Three major mechanisms lead to metabolic acidosis: 1) increased acid generation 2) loss of bicarbonate 3) decreased renal acid excretion. In AKI reduction of urine output and dimi-nished renal acid excretion results in subsequent metabolic acidosis.
Typical indications for renal replacement therapy (RRT) are hyperkalaemia, severe metabolic acidosis, diuretic-resistant volume overload, oliguria, anuria, uremic complications and some drug intoxications.
The use of RRT in Intensive Care Unit (ICU) patients increased over the last decades. In ICU setting continuous renal replacement therapies (CRRT) like continuous veno-venous hemodialysis (CVVHD) and continuous veno-venous hemodiafiltration are frequently used. Especially haemodynamic unstable patients benefit from CRRT compared to intermittent hemodialysis. Exact timing of starting CRRT and optimal intensity is still unk-nown.
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
- 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
- •Metabolic or mixed acidosis with pH ≤ 7.25 and base excess ≤ -6 mmol/l
- •Age ≥ 18 years
- •Acute kidney injury with need for Renal Replacement Therapy (RRT)
排除标准
- •Pregnancy
- •Wards of the state/Prisoners
- •Expected survival of less than 24 hours
- •Contraindication for citrate anticoagulation
- •Extracorporeal membrane oxygenation (ECMO)
结局指标
主要结局
Hours alive with normal pH (≥ 7.35) within first 24 hours of therapy
时间窗: First 24 hours after initiation of study-specific therapy
pH values are measured to determine acidaemia in critically ill patients. As defined by the study protocol, pH ≤ 7.25 and base excess ≤ -6 mmol/l are required to diagnose metabolic or mixed acidosis. Normalisation of pH (defined as ≥ 7.35, representing the lower margin of the pyhsiological pH range) is used as a surrogate marker for reversal of acedaemia and, thereby, device effectiveness. The time (hours) alive within the defined physiological range after initiation of therapy in the first 24 hours will be used to compare the intervention and control group.
次要结局
- Days free of mechanical ventilation within the first 28d after randomization(From start of study-specific therapy until day 28)
- Course of severity of organ failure(Assessment at baseline, days 1, 2, 3, 7, 14, 21, 28 as long as patient is still on intensive care unit)
- Course of systemic hemodynamics(Timepoints Baseline, 0.5, 1, 2, 4, 6, 8, 12, 16, 20, 24, 48, 72 hours. If patient is still on intensive care unit, also on day 7, 14, 28)
- Biomarkers (i.e. markers of inflammation, coagulation, endothelial function, metabolism, drug monitoring)(Assessment at Baseline and time points 4, 16, 24, 48, 72 hours after initiation of study specific therapy as well as on day 7 and 28, if patient is still on intensive care unit)
- Days free of renal replacement therapy within the first 28d after randomization(Assessment at baseline, days 1, 2, 3, 7, 14, 21, 28 as long as patient is still on intensive care unit)
- Requirement and number of transfusions during ICU(Cumulative assessment until day 28 or end of intensive care unit stay, whichever comes first.)
- Time to first pH normalisation (≥ 7.35)(First 24 hours after initiation of study-specific therapy)
- Days free of vasopressor therapy within the first 28d after randomization(From initiation of study-specific therapy until day 28)
- Course of arterial blood gases(Time points Baseline, 0.5, 1, 2, 4, 6, 8, 12, 16, 20, 24, 48, 72 hours. If patient is still on intensive care unit, also on day 7, 14, 28)
- 28 days and 90 days mortality(Assessment of status on day 28 and day 90)
- Intensive Care Unit and hospital length of stay(Assessment of status on day 28 and day 90)