COOLEY- Study: aCute On chrOnic Liver failurE Using the cYtosorb Device
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- The impact of CytoSorb on serum bilirubin removal
研究概览
简要总结
A Prospective, Single-Center trial, in Patients With Acute on Chronic Liver Failure. Study of Standard Medical Care Plus CytoSorb® Compared to Standard Medical Care Alone in a historical group.
详细描述
The study team wants to investigate the effect of Cytosorb hemoadsorption on the bilirubin level as well as on the ammonia level changes induced by the therapy in patients with Acute on Chronic Liver Failure (ACLF) .
In this group of patients with ACLF grade 2 and 3 the investigators want to determine the prevalence and development of sarcopenia by sequential quadriceps and thenar ultrasound images and by handgrip strength measurement.
The investigators will objectify muscle mass by skeletal muscle ultrasound of quadriceps and thenar muscles in this sickest subgroup of cirrhotic patients. Ultrasound forms a part of the daily clinical routine in ICU. The study team wants to compare both measurements and objectify the evolution to study the reliability and validity of ultrasound to quantify muscles in chronic liver disease and its clinical values. Most of ultrasonographic studies are based on quadriceps exploration, which is more inconvenient and takes more time than exploring the hands because patients need to remove clothes and lie down. The study team also hypothesizes that thenar muscles are less subject to fluid overload than the quadriceps muscles are.
When available, lumbar skeletal muscle indices will be compared by computed tomography or magnetic resonance imaging.
In this group of patients with ACLF, receiving Continuous Renal Replacement Therapy (CRRT) the appropriate choice of anticoagulant remains controversial. The objective of this study is to compare the efficacy and safety of regional citrate anticoagulation (RCA) and Low Molecular Weight Heparin (LMWH) in critically ill ACLF patients requiring CRRT. These two commercially available anticoagulation methods are used in daily practice in the ICU. The first 10 patients will receive anticoagulation with LMWH with monitoring of anti-Xa. The second cohort of patients will receive RCA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •adult patients (≥ 18 years) admitted to the University Hospital of Antwerp (UZA), Belgium.
- •Written informed consent from patient or if not possible due to encephalopathy (> grade 2): legal representative
- •acute-on-chronic liver failure (ACLF) grade ≥ 2:
- •Acute decompensation event (identifiable trigger)
- •Hepatic encephalopathy grade ≥ 2
- •Acute kidney injury (AKI) according to Kidney Disease: Improving Global Outcome (KDIGO) criteria stage 3 (≥ 3-fold increase of serum creatinine OR increase of serum creatinine to ≥ 4 mg/dl OR urine output ≤ 0.3 ml/kg/h for ≥ 24 hours OR anuria for ≥ 12 hours)
- •Serum bilirubin ≥ 10 mg/dl
- •Hemodynamic instability with vasopressor support (norepinephrine > 0.05 mcg/kg/min)
排除标准
- •• known patient will against participation in the study or against the measures applied in the study
- •a decision made prior to inclusion to stop further treatment of the patient within the next 24 hours
- •no complete remission of malignancy including hepatocellular carcinoma within the past 12 months
- •ongoing intermittent or CRRT before study inclusion
研究组 & 干预措施
CytoSorb hemoadsorption
Patients with acute on chronic liver failure will receive CytoSorb treatment for 72 hours. The aim is to remove the molecules that drive systemic inflammation.
干预措施: CytoSorb (Device)
Control group
Historical group that received only standard medical care
结局指标
主要结局
The impact of CytoSorb on serum bilirubin removal
时间窗: 24 and 72 hours
20 participants with a serum bilirubin of ≥ 10 mg/dl will undergo CytoSorb for 72 hours
Changes in ammonia and severity of hepatic encephalopathy during treatment period
时间窗: 24 and 72 hours
The West Haven criteria are used for grading the severity of hepatic encephalopathy, which include 5 grades ranging from minimal (slightly impaired) to grade IV (comatose)
次要结局
- Ventilation(0, 24 and 72 hours)
- Cytosorb filter(up to 28 days after enrolment)
- Sarcopenia(0, 24 and 72 hours)
- changes in hemodynamic profile(24 and 72 hours)
- Vasopressors(24 and 72 hours)
- ACLF (Acute on Chronic Liver Failure) Grading(first week)
- SOFA Score(0, 72 and 168 hours)
- scores(15 days)
- Cytokines(0, 24 and 72 hours)
- Mortality(28, 60 and 90 days after enrolment)
- Improvement of Renal function after application of CytoSorb(7, 14, 21 and 90 days after enrolment)
- Change in Bile acids(72 hours after enrolment)
- Change in inflammatory values: procalcitonin(Day 0, Day 1 and Day 3)
- Change in inflammatory values: lactate(Day 0, Day 1 and Day 3)
- Anticoagulation(0, 24 and 72 hours)
- SAPS II score(Day 0, Day 3, Day 7)
研究者
Karolien Dams
Principal Investigator, MD, senior staff intensive care
University Hospital, Antwerp