NCT04898010暂停不适用
Investigator Initiated Pilot Study to Assess the Safety and Efficacy of a Selective Cytopheretic Device (SCD) to Treat ICU Patients With Acute Kidney Injury (AKI) and Hepatorenal Syndrome (HRS) Type I
Lenar Yessayan2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2022年6月9日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Number of serious adverse events related to selective cytopheretic device (SCD)
研究概览
简要总结
This research study is being done to learn what effect 7 days of treatment with the Selective Cytopheretic Device (SCD) will have on these white blood cells in the bloodstream of patients with hepatorenal syndrome and to learn whether it has any effect on the blood circulation and kidney function.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cirrhosis with ascites.
- •Not currently listed for liver transplant.
- •Worsening renal failure most likely due to Hepatorenal Syndrome Type I with low glomerular filtration rate (GFR).
- •No sustained improvement in renal function after diuretic withdrawal and expansion of plasma volume with 1.5 liters of plasma expander.
- •No sustained improvement in renal function or intolerant to treatment with octreotide and /or midodrine.
- •Able to tolerate regional citrate anticoagulation and continuous renal replacement therapy (CRRT) for 24 hours or greater.
- •Intent to deliver full supportive care through aggressive management utilizing all available therapies for a minimum of 96 hours.
- •Receiving medical care in an intensive care unit.
- •Absence of shock, ongoing bacterial infection and fluid losses, and current treatment with nephrotoxic medications, hepatocellular carcinoma.
- •Females of child bearing potential who are not pregnant (confirmed by a negative serum pregnancy test) and not lactating if recently post-partum.
- •Two (2) consecutive intra-circuit Ionized Calcium (iCa) levels <0.40 Millimoles per liter (mmol/L), at least 30 minutes apart.
排除标准
- •Evidence of chronic kidney disease Stage
- •Patients with Model for End-Stage Liver Disease (MELD) score > 40 (since these patients are unlikely to survive a 90-day follow-up period).
- •Acute or chronic use of circulatory support device.
- •Mechanical ventilation for greater than 7 consecutive days.
- •AKI occurring in the setting of burns, obstructive uropathy, allergic interstitial nephritis, acute or rapidly progressive glomerulonephritis, vasculitis, hemolytic uremic syndrome, thrombotic thrombocytopenic purpura (TTP), malignant hypertension, scleroderma renal crisis, atheroembolism, functional or surgical nephrectomy, cyclosporine or tacrolimus nephrotoxicity. No evidence of intrinsic parenchymal renal disorder, ultrasonic evidence of obstructive uropathy or proteinuria greater than 500 mg/day.
- •Presence of any organ transplant at any time.
- •Metastatic malignancy which is actively being treated or may be treated by chemotherapy or radiation during the subsequent three-month period after study protocol therapy.
- •Severe, uncontrolled cardiac disease.
- •Chronic immunosuppression.
- •Medical history of HIV or AIDS.
- •Current Do Not Attempt Resuscitation (DNAR), Allow Natural Death (AND), or withdrawal of care status, or anticipated change in status within the next 7 days.
- •Patient is moribund or chronically debilitated for whom full supportive care is not indicated.
- •Dry weight >150 kg.
- •Platelet count <30,000/mm
- •Concurrent enrollment in another interventional clinical trial. Patients enrolled in clinical studies where only measurements and/or samples are taken (i.e., no test device or test drug used) are allowed to participate
- •Use of any other investigational drug or device within the previous 30 days
- •Patient is a prisoner.
结局指标
主要结局
Number of serious adverse events related to selective cytopheretic device (SCD)
时间窗: Up to 90 days
Number of deaths related to selective cytopheretic device
时间窗: Up to 90 days
Number of unforeseen malfunction(s) that results in the need for discontinuation
时间窗: Up to 7 days
Number if events with evidence of leakage (i.e., cracking/breakage of a port, connector, SCD casing cartridge or tubing).
时间窗: Up to 7 days
Number of events of significant clotting within the device as assessed by visual inspection
时间窗: Up to 7 days
Source documentation will record either present, absent, or not-assessed
次要结局
- Change in renal function(Baseline (prior to dialysis), days 1-5 post SCD, days 30 and 90 (among survivors and those free from dialysis) (+/- 7 days))
- Change in coagulation parameters(Baseline (prior to dialysis), Days 1-5 post SCD or until ICU discharge (if earlier than 5 days) and at days 30 and 90 (among survivors) (+/- 7 days).)
- Change in liver function(Baseline (prior to dialysis), Days 1-5 post SCD or until ICU discharge (if earlier than 5 days) and at days 30 and 90 (among survivors) (+/- 7 days).)
- Dialysis independence(Up to 90 (+/- 7 days))
- Change in model for end-stage liver disease (MELD) score(Baseline (prior to dialysis), Days 1-5 post SCD or until ICU discharge (if earlier than 5 days) and at days 30 and 90 (among survivors) (+/- 7 days).)
研究者
Lenar Yessayan
Associate Professor of Internal Medicine
University of Michigan
研究点 (2)
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