Journal of the American Society of Nephrology : JASN
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J. Am. Soc. Nephrol. · Feb 2004
Randomized Controlled Trial Comparative Study Clinical TrialA randomized, controlled trial of albumin versus saline for the treatment of intradialytic hypotension.
Intradialytic hypotension (IDH) is the most common complication of hemodialysis. Symptomatic IDH requires the administration of fluid and often results in the early termination of dialysis, both of which may prevent adequate fluid removal. The optimal fluid for the treatment of IDH remains unknown. ⋯ The postdialysis systolic BP (121 +/- 19 mmHg versus 117 +/- 19 mmHg; P = 0.32), postdialysis diastolic BP (63 +/- 9 mmHg versus 61 +/- 9 mmHg; P = 0.33), volume of study fluid used to treat IDH (403 +/- 170 ml versus 428 +/- 191 ml; P = 0.34), time required to restore the BP (7.9 +/- 6.6 min versus 9.9 +/- 7.5 min; P = 0.09), total nursing time required to manage the hypotensive episode (15.1 +/- 7.2 min versus 15.9 +/- 7.3 min; P = 0.47), number of treatment failures (22% versus 24%; P = 1.0), and the frequency of recurrent IDH (36% versus 36%) were not significantly different when 5% albumin was used compared with saline. It is concluded that 5% albumin is no more effective than normal saline for the treatment of IDH in chronic hemodialysis patients. Normal saline should be used as the initial fluid for the treatment of IDH.
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J. Am. Soc. Nephrol. · Jan 2003
Randomized Controlled Trial Multicenter Study Clinical TrialHemodialysis infection prevention with polysporin ointment.
Hemodialysis patients in whom permanent vascular access cannot be achieved are dependent on a central venous catheter. In such patients, catheter-related infections are a common and serious complication. This study was a randomized clinical trial to determine if topical Polysporin Triple antibiotic ointment applied to the central venous catheter insertion site could reduce the incidence of catheter-related infections. ⋯ When all available follow-up information was included, the difference in survival remained significant (19 versus 9 deaths; P = 0.0027). Within the first 6 mo, infections were observed in 7 of the 13 placebo subjects who died (54%) as compared with no infections in the three Polysporin Triple subjects who died. The prophylactic application of topical Polysporin Triple antibiotic ointment to the central venous catheter insertion site reduced the rate of infections and was associated with improved survival in hemodialysis patients.
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J. Am. Soc. Nephrol. · Jul 2002
Randomized Controlled Trial Clinical TrialCardiac and renal effects of standard versus rigorous blood pressure control in autosomal-dominant polycystic kidney disease: results of a seven-year prospective randomized study.
This study sought to investigate the cardiac and renal effects of rigorous versus standard BP control on autosomal-dominant polycystic kidney disease (ADPKD). A prospective, randomized, 7-yr study was performed to examine the effect of rigorous (<120/80 mmHg) versus standard (135-140/85-90 mmHg) BP control on left ventricular mass index (LVMI) and kidney function in 75 hypertensive ADPKD patients with left ventricular hypertrophy. LVMI was measured by echocardiogram at baseline and at 1 and 7 yr. ⋯ There was no statistically significant difference in renal function between the two groups. In conclusion, left ventricular hypertrophy, a major cardiovascular risk factor, was decreased to a significantly greater extent by rigorous than standard BP control. This finding has particular clinical importance because cardiovascular complications are the most common cause of death in ADPKD patients.
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J. Am. Soc. Nephrol. · Jun 2002
Randomized Controlled Trial Multicenter Study Clinical TrialOral sulodexide reduces albuminuria in microalbuminuric and macroalbuminuric type 1 and type 2 diabetic patients: the Di.N.A.S. randomized trial.
Diabetic nephropathy may be effectively prevented and treated by controlling glycemia and administering angiotensin-converting enzyme (ACE) inhibitors. However, strict metabolic control can be difficult, and ACE inhibitors may be poorly tolerated and only partially effective, particularly in diabetes mellitus type 2 (DM2), warranting the search for ancillary treatment. Sulodexide is a glycosaminoglycan, a new class of drug that has demonstrated nephroprotective activity in experimental investigations. ⋯ Very few adverse events were reported; none were serious. In conclusion, a 4-mo course of high doses of sulodexide significantly and dose-dependently improves albuminuria in DM1 and DM2 patients and micro- or macroalbuminuric patients with or without concomitant ACE inhibition. The effect on albuminuria is long-lasting and seemingly additive to the ACE inhibitory effect.
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J. Am. Soc. Nephrol. · Jan 2002
Randomized Controlled Trial Multicenter Study Clinical TrialContinuous dialysis with bicarbonate/lactate-buffered peritoneal dialysis fluids results in a long-term improvement in ex vivo peritoneal macrophage function.
To circumvent the potentially negative consequences of long-term exposure to unphysiologic acidic lactate-buffered peritoneal dialysis fluids (PDF), neutral pH solutions buffered with bicarbonate/lactate have recently been introduced in phase 2 and 3 clinical trials. This study examines the longitudinal changes in peritoneal macrophage (PMØ) function in patients dialyzed continuously with either lactate (LPD; 40 mM lactate, pH 5.2)-buffered or bicarbonate/lactate (TBL; 25 mM/15 mM bicarbonate/lactate, pH 7.3)-buffered PDF. Before the study, during the run in period of a phase 3 clinical trial, all patients had been taking LPD for at least the previous 18 wk. ⋯ At 6 mo, STZ-stimulated PMØ TNF-alpha synthesis was significantly higher in patients treated with TBL compared with those treated with LPD (P = 0.0035). These data suggest that in patients continuously dialyzed with a neutral pH solution, there is a long-term improvement in PMØ function compared with patients on conventional therapy. Better PMØ function suggests improved host defense status and may affect the peritoneum's susceptibility to infection and potentially reduce the negative consequences of repeated intraperitoneal inflammation on long-term membrane function.