NCT02335723终止不适用
Abdominal Septic Shock - Endotoxin Adsorption Treatment (ASSET) - a Double-Blind, Randomized Placebo-Controlled Clinical Investigation With Alteco® LPS Adsorber
Alteco Medical AB12 个研究点 分布在 3 个国家目标入组 15 人开始时间: 2015年9月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 15
- 试验地点
- 12
- 主要终点
- Characterization of all reported USADEs and ASADEs.
研究概览
简要总结
The primary objective of this clinical investigation is to investigate the feasibility and possible benefits of the Alteco® LPS Adsorber in treating patients with septic shock with presumed endotoxemia of abdominal or urogenital origin.
详细描述
OVERALL CLINICAL INVESTIGATION DESIGN:
This is a multicentre, stratified, parallel, double-blinded, randomized, feasibility clinical investigation of the Alteco® LPS Adsorber.
Subjects will be enrolled in an adaptive fashion with up to two interim analyses, and the possibility of recruiting additional patients, in order to establish an indication of the feasibility of treating a target population of subjects with septic shock and endotoxemia.
Subjects will be stratified in accordance with the origin of their infection, i.e. abdominal or urogenital sepsis. Subjects in each stratum will receive either:
- LPS Adsorber group (i.e. investigational medical device [IMD] group): current best practice in combination with Alteco® LPS Adsorber treatment, OR
- Placebo device group (i.e. comparator group): current best practice in combination with placebo adsorber treatment.
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
- Quadruple (Participant, Care Provider, Investigator, 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
- •Illness severity criteria: At enrolment subjects must meet inclusion criteria #1 through #3 listed below to be eligible to enter the clinical investigation:
- •Subjects must have suspected severe infection of abdominal or urogenital origin for which the subject is receiving intravenous antimicrobial therapy as the main reason for organ support
- •Subjects, males or females, must be 18 years or older.
- •Subjects or legally acceptable representatives, as appropriate, are willing and able to provide signed informed consent.
- •Treatment criteria: Prior to randomization, subjects must meet all inclusion criteria (#4 through #7) listed below to be assigned to a treatment group:
- •Appropriate vascular access must have been obtained.
- •Subjects must have received ≥ 30 mL/kg of intravenous fluid within the six (6) hours prior to randomization.
- •Subjects must have plasma/serum lactate >2 mmol/L despite adequate resuscitation AND a continuous requirement for vasopressor support
- •Subjects must be able to initiate the clinical investigation intervention within 12 hours of fulfilment of the illness severity criteria.
排除标准
- •Subjects who meet any of the exclusion criteria listed below will NOT be permitted to enter the clinical investigation: Sepsis-induced organ dysfunction for longer than 12 hours prior to the time-point for achieving "Illness severity criteria fulfilled"
- •Vasopressor therapy (at any dose) for longer than 12 hours (not included the time spent in the operation theatre) prior to the start of treatment with the investigational device.
- •Pre-existing uncorrectable medical condition as:
- •Poorly controlled neoplasms or hematologic disease (i.e. indication of disseminated cancer outside the suspected primary tumour and hematologic disease not in remission,
- •End-stage cardiac disease,
- •Cardiac arrest requiring cardiopulmonary resuscitation or with pulseless electrical activity or asystole within the past 7 days
- •End-stage lung disease
- •End-stage liver disease
- •HIV/AIDS with known end-stage processes
- •Other uncorrectable medical condition(s) deemed by the Clinical Investigator to hinder the subject to adhere to the fulfilment of the activities described in the Clinical Investigation Plan.
- •Extreme illness, i.e. subjects is moribund and death is perceived to be imminent (within 24 hours).
- •Recent or current participation (≤ 30 days) in another interventional sepsis trial.
- •Recent or current treatment (≤ 30 days) with an adsorption product, including Alteco® LPS Adsorber.
- •Treatment with an investigational medicinal product for any indication within the last 30 days before enrolment in the clinical investigation.
- •Contraindications to the use heparin or protamine
- •Other abdominal inflammatory conditions
- •Perforation of hollow organ linked to trauma within 48 hours before enrolment in the clinical investigation.
- •Laparotomy reveals isolated gastric ulcer.
- •Subjects and/or their immediate family are directly affiliated to investigative site personnel in this clinical investigation. (Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted).
研究组 & 干预措施
Alteco LPS Adsorber
Active Comparator
Hemoperfusion and Standard therapy
干预措施: Alteco LPS Adsorber (Device)
Placebo
Placebo Comparator
Placebo and Standard therapy. The placebo comparator device differs from Alteco® LPS Adsorber only in that no peptide component (i.e. active component) has been attached to the matrix.
干预措施: Placebo (Device)
结局指标
主要结局
Characterization of all reported USADEs and ASADEs.
时间窗: 6-28 days
次要结局
- Relative change from baseline in plasma endotoxin (p-endotoxin) levels during (i.e. at 2 hours) and immediately after end (i.e. at 6 hours) of treatment with device, on both Day 1 and Day 2.(2 days)
- Relative change from baseline in SOFA score(6-28 days)
- Relative change from baseline in renal function(6-28 days)
- Relative change from baseline in liver function(6-28 days)
- Relative change from baseline in circulatory support(6-28 days)
- Relative change from baseline in respiratory support(6-28 days)
- Relative change from baseline in ICU mortality(6-28 days)
- Relative change from baseline in ICU length of stay(6-28 days)
- Clinical outcome during stay at Hospital following ICU-discharge of the total extension of renal support(6-28 days)
- Clinical outcome during stay at Hospital following ICU-discharge of 28-day mortality(6-28 days)
- Clinical outcome during stay at Hospital following ICU-discharge of hospital length of stay up to 28 days(6-28 days)
- Levels of inflammatory response biomarkers(6-28 days)
- Determination of the molecular components extracted from blood circulation and captured in Alteco® LPS Adsorber.(6-28 days)
- Characterization of all reported AEs (regardless of attribution), ADEs, and device deficiencies(6-28 days)
研究者
研究点 (12)
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