MethLock vs. heparin as dialysis catheter lock
MethLock vs. heparin as dialysis catheter lock
批准号:
7264869
负责人:
STEPHEN R ASH
金额:
$176.21万
依托单位国家:
美国
项目类别:
财政年份:
2005
资助国家:
美国
项目状态:
已结题
起止时间:
2005-09-01 至 2008-12-31
关键词:
Adverse eventAnti-Bacterial AgentsAnticoagulantsBacteremiaBacteriaBloodBlood specimenCaringCase Report FormCatheter-related bloodstream infectionCathetersClinicalClinical TreatmentClinical TrialsClinical trial protocol documentCulture MediaDataDialysis procedureDrug EvaluationEffectivenessEnd PointEnd stage renal failureEnrollmentExcisionFailureGrantGuidelinesHemodialysisHeparinIn VitroIncidenceInfectionInterventionMeasurableMedical StaffMethylene blueModificationMulticenter StudiesMulticenter TrialsNumbersPatientsPeripheralPhasePhysical DialysisPilot ProjectsPropertyProtocols documentationPseudomonasPublishingRandomized Controlled Clinical TrialsRateResearchResearch Ethics CommitteesRiskSafetySepsisSiteSolutionsSpeedStandards of Weights and MeasuresTestingTimeUnited States Food and Drug AdministrationVenousbactericidefollow-upperipheral bloodpilot trialsizesodium citratestaff intervention
中文摘要
目前约有25%的终末期肾病患者接受血液透析治疗。
通过隧道中心静脉导管进行透析(CVCD)。标准
这些导管的抗凝剂锁是肝素,它没有抗菌特性。这个
使用CVCDs的终末期肾病患者最大的风险是导管相关的血流感染;
(CRBSI),并经常进展为败血症。方法锁是一种导尿管锁,包括
亚甲蓝(一种抗菌物质)和柠檬酸钠(7%,一种抗凝剂)。体外培养;
对MethLock的研究表明,它对所有细菌都有杀菌作用,即使在
稀释的血液或培养液。此第一阶段和第二阶段拨款将支持多中心
MethLock与肝素作为导管锁定的安全性和有效性的随机试验
隧道CVCD。该协议已经得到了FDA的批准,并为用于
审判。主要终点是CRBSI(从外周提取的一致细菌培养物
血液和导管管腔),以及因通畅失败而拔除导管(在演示之后
与基线治疗相比,透析过程中的流速至少下降了25%)。每个病人都会
被跟踪长达6个月,研究的规模(400名患者)将提供足够的数据来
证明与肝素相比,方法锁是否降低CRBSI的发生率,同时维持
导管的通畅度等于肝素。研究的终点是客观的,而且很容易定义
但尚未在CVCD或导管锁的全面临床试验中得到验证。在第一阶段,我们将
在一个透析中心(试点中心)实施该方案,以确定
试验,分析:患者登记的简易性,不良事件的识别速度,以及
我们定义的终点与工作人员对CVCDS的临床干预之间的总体相关性。
在第一阶段之后,我们将确定是否需要修改协议,如果需要,将请求
食品和药物管理局的方案修改。在第二阶段,我们将在以下几个方面实施该协议
并按照最初的建议或第一阶段后的修改完成研究。
英文摘要
Currently about 25% of patients on hemodialysis therapy for End Stage Renal Disease (ESRD)
receive dialysis through tunneled central venous catheters for dialysis (CVCD). The standard
anticoagulant lock for these catheters is heparin, which has no antibacterial properties. The
greatest risk for ESRD patients using CVCDs access is catheter related bloodstream infection ;
(CRBSI), with frequent progression to sepsis. MethLock ¿ is a catheter lock comprised of
methylene blue (an antibacterial substance) and sodium citrate (7%, an anticoagulant). In vitro ;
studies of MethLock have shown that it is bactericidal for all bacteria, even in the presence of
diluted blood or culture medium. This Phase I and Phase II grant will support a multicenter
randomized trial of the safety and effectiveness of MethLock versus heparin as a catheter lock in
tunneled CVCD. The protocol has been approved by the FDA and an IDE granted for MethLock for
the trial. The primary endpoints are CRBSI (concordant bacterial culture drawn from peripheral
blood and the catheter lumen) and removal of the catheter for patency failure (after demonstration
of at least 25% decrease in flow rate during dialysis versus a baseline treatment). Each patient will
be followed for up to 6 months, and the size of the study (400 patients) will provide enough data to
demonstrate whether MethLock decreases the incidence CRBSI versus heparin while maintaining
patency of catheters equal to heparin. The endpoints of the study are objective and easily definable
but have not been validated in a full-scale clinical trial of CVCD or catheter lock. In Phase Iwe will
implement the protocol at one dialysis center (a "pilot" center) to determine the practicality of the
trial, analyzing: the ease of patient enrollment, speed of identification of adverse events, and the
general correlation between our defined endpoints and clinical interventions by staff on theCVCDs.
After Phase I we will determine whether the protocol needs to be modified and if so will request
protocol modifications from the FDA. In Phase II we will implement the protocol in a number of
dialysis centers and complete the study as originally proposed or as modified after Phase I.
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MethLock vs. heparin as dialysis catheter lock
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批准号:6935046
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项目类别:
-
资助金额:$10.0万
-
财政年份:2005
-
负责人:STEPHEN R ASH
-
依托单位:
MethLock vs. heparin as dialysis catheter lock
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批准号:7341763
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项目类别:
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资助金额:$89.94万
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财政年份:2005
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负责人:STEPHEN R ASH
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依托单位:
Pheresis Treatment of Bioterrorism-Induced Sepsis
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批准号:6885339
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项目类别:
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资助金额:$50.69万
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财政年份:2004
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负责人:STEPHEN R ASH
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依托单位:
Pheresis Treatment of Bioterrorism-Induced Sepsis
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批准号:6742356
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项目类别:
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资助金额:$50.47万
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财政年份:2004
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负责人:STEPHEN R ASH
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依托单位:
SUB-Q ULTRAFILTER/INFUSION DEVICE (SQUID) FOR INSULIN
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批准号:6020112
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项目类别:
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资助金额:$10.0万
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财政年份:1999
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负责人:STEPHEN R ASH
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依托单位:
BIOREACTOR WITH DIRECT PLASMA CONTACT FOR LIVER ASSIST
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批准号:2539002
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资助金额:$9.99万
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财政年份:1998
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负责人:STEPHEN R ASH
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依托单位:
DNA CHARCOAL PLASMA SORPTION FOR TREATMENT OF SLE
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批准号:2717405
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项目类别:
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资助金额:$10.0万
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财政年份:1998
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负责人:STEPHEN R ASH
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依托单位:
BIOIMPEDANCE CONTROL OF ULTRAFILTRATION ON HEMODIALYSIS
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批准号:2150850
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项目类别:
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资助金额:$10.0万
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财政年份:1995
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负责人:STEPHEN R ASH
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依托单位:
LIVER ASSIST BY PUSH-PULL SORBENT-REGENERATIVE PHERESIS
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批准号:2148304
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项目类别:
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资助金额:$10.0万
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财政年份:1995
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负责人:STEPHEN R ASH
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依托单位:
ENHANCING EFFICACY OF BIOLOGIC-DT LIVER ASSIST DEVICE
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批准号:2147567
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项目类别:
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资助金额:$5.4万
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财政年份:1994
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负责人:STEPHEN R ASH
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依托单位:
MONITORING DRUG THERAPY THROUGH SMARTCHART
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批准号:3495871
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项目类别:
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资助金额:$5.0万
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财政年份:1989
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负责人:STEPHEN R ASH
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依托单位:
BIOLOGIC-PD--A NIGHTTIME PERITONEAL CYCLER
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批准号:3495757
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项目类别:
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资助金额:$5.0万
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财政年份:1988
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负责人:STEPHEN R ASH
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依托单位:
BIOLOGIC-DC SYSTEM FOR REMOVING CO2 FROM BLOOD
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批准号:3495790
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项目类别:
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资助金额:$5.0万
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财政年份:1988
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负责人:STEPHEN R ASH
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依托单位:
SORBENT SYSTEM FOR HEMODIALYSIS
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批准号:3495709
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项目类别:
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资助金额:$5.0万
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财政年份:1987
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负责人:STEPHEN R ASH
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依托单位:
INDWELLING FISTULA ACCESS DEVICE FOR HEMODIALYSIS
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批准号:3495692
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项目类别:
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资助金额:$5.0万
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财政年份:1987
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负责人:STEPHEN R ASH
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依托单位:
SINGLE-ACCESS, SORBENT-BASED HOME DIALYSIS
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批准号:3507276
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项目类别:
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资助金额:$4.73万
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财政年份:1984
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负责人:STEPHEN R ASH
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依托单位:
SINGLE-ACCESS, SORBENT-BASED HOME DIALYSIS
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批准号:3507274
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项目类别:
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资助金额:$45.27万
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财政年份:1984
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负责人:STEPHEN R ASH
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依托单位:
海外基金