NL-OMON53033招募中不适用
Study into the effect of CytoSorb (cytokine adsorber) in relation to the MICrocirculation of patients with Septic Shock and Acute Kidney Injury at the ICU; MICSS-AKI - Microcirculatory response to cytokine removal therapy
Erasmus Universiteit Rotterdam0 个研究点目标入组 40 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Each patient, weight above 60 kg with septic shock needing vasopressors or
- •lower dosis norepinephrine supplemented with dobutamine, vasopressin
- •(argipressin) /terlipressin/epinephrine must meet all of the following criteria
- •to be enrolled in this study:
- •1. Has written informed consent from patient or legal representative.
- •2. Is aged 18 to 85 years, inclusive a weight above 60 kg.
- •3. Is admitted to the ICU
- •4. Has diagnosis of septic shock according to the criteria defined by Singer et
- •al in the Third International Consensus Definitions for Sepsis and Septic Shock
- •(Sepsis-3) published in JAMA, 2016.
- •Organ dysfunction acute change in total SOFA score >=2 points consequent to
- •the infection or Quick SOFA (qSOFA,): alteration in mental status, systolic
- •blood pressure <=100 mm Hg, or respiratory rate >=22/min.
- •Patients with septic shock can be identified with a clinical construct of
- •sepsis with persisting hypotension requiring vasopressors to maintain MAP >=65
- •mm Hg and having a serum lactate level >2 mmol/L despite adequate volume
- •resuscitation.
- •5. Has diagnosis of AKI, defined as the following:
- •AKI Stage 2 according to the following KDIGO guidelines criteria, based on
- •changes in Serum Creatinine (SCr), urine output or both:
- •a. Increase in SCr 2.0-2.9 times baseline and or a Urine Output (UO) < 0.5
- •ml-kg-h for >= 12 hours compared with a SCr value within the previous 48 hours.
- •b. The reference SCr value is a SCr value in the following order of preference:
- •1. Lowest value within 3 months of hospital admission if not available:
- •2. At hospital admission. If not available:
- •3. At ICU admission. If not available:
- •4. Lowest value between 3 and 12 months prior to hospital admission
- •6. Has a deteriorated sublingual microcirculation measured by Cytocam-IDF
- •imaging and quantified by determining the MFI as < 2,6.
排除标准
- •Patients meeting any of the following criteria will be excluded from the study:
- •1. Moribund
- •2. Woman of childbearing potential with a positive pregnancy test
- •3. Has a diagnosis of septic shock longer than 24 hours before inclusion
- •4. Has a normal sublingual microcirculation
- •5. Neutropenia; absolute neutrophil count less than 1000/um
- •6. Thrombocytopenia (less than 20.000/um)
- •7. Any body weight lower than 60 kg.
- •8. Treatment with intravenous aminoglycosids or antifungal therapy
研究者
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