Clinical journal of the American Society of Nephrology : CJASN
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Clin J Am Soc Nephrol · Apr 2010
Randomized Controlled Trial Multicenter StudyA phase III, randomized, double-blind, placebo-controlled study of tenecteplase for improvement of hemodialysis catheter function: TROPICS 3.
Despite widespread use of tunneled hemodialysis (HD) catheters, their utility is limited by the development of thrombotic complications. To address this problem, this study investigated whether the thrombolytic agent tenecteplase can restore blood flow rates (BFRs) in dysfunctional HD catheters. ⋯ Tenecteplase improved HD catheter function and had a favorable safety profile compared with placebo.
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Clin J Am Soc Nephrol · Feb 2010
Randomized Controlled TrialUltrasound-guided femoral dialysis access placement: a single-center randomized trial.
Insertion of dialysis catheters (DCs) is a prerequisite for successful initiation of hemodialysis. We attempted to determine if ultrasonography-guided (USG) insertion was superior and safer than the anatomical landmark-guided technique (ALT) for the femoral vein (FV). ⋯ USG significantly improves success rate, reduces number of attempts, and decreases the incidence of complications related to FV DC insertion.
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Clin J Am Soc Nephrol · Jul 2009
Randomized Controlled Trial Multicenter Study Comparative StudyContrast-induced nephropathy and long-term adverse events: cause and effect?
The relationship of contrast-induced nephropathy (CIN) to long-term adverse events (AEs) is controversial. Although an association with AEs has been previously reported, it is unclear whether CIN is causally related to these AEs. ⋯ The parallel decrease in the incidence of CIN and AEs in one arm of this randomized trial supports a causal role for CIN.
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Clin J Am Soc Nephrol · Apr 2009
Randomized Controlled Trial Comparative StudyProspective change in renal volume and function in children with ADPKD.
Autosomal dominant polycystic kidney disease (ADPKD) is a progressive hereditary disorder affecting children and young adults. Early intervention may be necessary to significantly affect the long-term consequences of this disease. ⋯ Close monitoring of cardiovascular and renal status is indicated in ADPKD children with hypertension or borderline hypertension. In contrast to effects in hypertensive ADPKD children, ACEI treatment in normotensive or borderline hypertensive ADPKD children may prevent the development of increased LVMI and deterioration in renal function.
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Clin J Am Soc Nephrol · Feb 2009
Randomized Controlled Trial Multicenter StudyDesign of combination angiotensin receptor blocker and angiotensin-converting enzyme inhibitor for treatment of diabetic nephropathy (VA NEPHRON-D).
Both angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) can slow the progression of diabetic nephropathy. Even with ACEI or ARB treatment, the proportion of patients who progress to end-stage renal disease (ESRD) remains high. Interventions that achieve more complete blockade of the renin-angiotensin system, such as combination ACEI and ARB, might be beneficial. ⋯ Tertiary endpoints are cardiovascular events, slope of change in eGFR, and change in albuminuria at 1 yr. Specific safety endpoints are serious hyperkalemia (potassium > 6 mEq/L, requiring admission, emergency room visit, or dialysis), all-cause mortality, and other serious adverse events. This paper discusses the design and key methodological issues that arose during the planning of the study.