Impact of a Continuous Dialysis Technique Associated With Adsorption Capacity Membranes in Patients With Sepsis Associated - Acute Kidney Injury.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 4
- 主要终点
- Technical CRRT efficiency
研究概览
简要总结
Septic patients with acute kidney injury (SA-AKI) requiring continuous renal replacement therapies (CRRT) present high mortality due to systemic inflammatory response, cytokine liberation, and finally multiorgan dysfunction. Cytokine plasmatic elimination with continuous venovenous hemofiltration (CVVH) presents frequent complications, known as "dialytrauma", and a high resource cost both technical and human. The study primary end-point is to demonstrate a longer filter life with the use of continuous venovenous hemodialysis (CVVHD) respect to CVVH, both modalities employing the same adsorption capacity membrane. As secondary end-points investigators will try to demonstrate less dialytrauma events of CVVHD respect to CVVH. In order to achieve these objectives investigators have designed a proof of concept exploratory trial that will include those patients whom present SA-AKI meeting CRRT initiation criteria. During the first 72 hours investigators will measure plasmatic elimination capacity of main cytokines, and other clinical and prognostic relevant molecules. Investigators will also measure hemodynamic, respiratory, and metabolic parameters. Adverse effects related to CRRT ("dialytrauma") will also be registrated. Finally, investigators will analyze 90 days survival. Demonstration of a minor complication rate (longer filter patency with less dialytrauma events) with a similar immunomodulating capacity and with its consequent lower cost, should settle the based evidence principles that recommend the use of CVVHD asociated to an adsorption capacity membrane in patients with SA-AKI whom need CRRT.
详细描述
Investigators will warrant a correct protocol application. Study data will be reviewed by an external monitoring committee from the clinical assay research central unit (UCICEC - IDIBELL). Monitors will contrast registered data from the collection data form (CDF) with data from patient´s medical record. All patient´s medical records will be indefinitely saved in electronical format to be reviewed if necessary.
Patients who meet inclusion criteria will be randomized for one of both arms with aleatory assignation using a randomisation sequential (RndSeq) program for Statistical Package for the Social Sciences (SPSS). Adverse events will be reported (in less than 24 hours if severe) to the sponsor center to be properly evaluated. If the severe adverse event (SAE) is finally evaluated by the study board as related to the intervention arm, urgent notification to health authorities must proceed and study should be interrupted until further decision.
As a pilot study of at least 50 cases is advisable in many circumstances (Sim and Lewis, 2012), and we wanted to compare two treatment options, we aimed to recruit at least 100 patients.
Missing data will try to be avoided by an exhaustive patient´s follow up by study investigators. Intention to treat analysis (ITT) will be the main strategy and statistical substitution techniques for missing data will be applied when necessary. Per protocol analysis will also be done to avoid possible bias. Out-of-range results will be identified and processed with adequate statistical techniques.
Data registry has been created to include all variables with written individual data collection forms (DCF). Data will be bedside registered by the study members but final software database registration will be done by the statistics outside investigator who has no contact with patients situation. Cytokines levels will be introduced in DCF when measured (every six months).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Less than 72 hours from ICU admission to inclusion
- •Clinical diagnosis of Severe Sepsis or Septic shock (SCCM definitions)
- •Correct therapeutic initial management of septic process (SSC guidelines)
- •Clinical diagnosis of Acute Kidney Injury (ADQI definitions)
- •Acute Kidney Injury meeting CRRT initiation criteria (ADQI guidelines)
- •Written informed consent from patient or legal surrogates
排除标准
- •End Stage Renal Disease(ESRD)
- •Received previous CRRT or hemodialysis in the last three months
- •Inclusion in other ongoing study
- •Coexisting illness with a high probability of death
- •Immunosuppression
结局指标
主要结局
Technical CRRT efficiency
时间窗: 72 hours
Number of times set was changed.
次要结局
- Renal depuration capacity.(72 hours.)
- Hemodynamics and respiratory variations.(72 hours.)
- Clinical efficiency(90 days)
- Immunomodulating capacity(72 hours)
- Safety technical superiority.(72 hours)
- Survival at 90 days after randomization(90 days.)
研究者
Joan Sabater Riera
Medical Doctor
Hospital Universitari de Bellvitge