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Randomized Controlled Trial
. 2012 Dec 13;367(24):2296-304.
doi: 10.1056/NEJMoa1210357. Epub 2012 Nov 6.

Ultrafiltration in Decompensated Heart Failure With Cardiorenal Syndrome

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Free PMC article
Randomized Controlled Trial

Ultrafiltration in Decompensated Heart Failure With Cardiorenal Syndrome

Bradley A Bart et al. N Engl J Med. .
Free PMC article

Abstract

Background: Ultrafiltration is an alternative strategy to diuretic therapy for the treatment of patients with acute decompensated heart failure. Little is known about the efficacy and safety of ultrafiltration in patients with acute decompensated heart failure complicated by persistent congestion and worsened renal function.

Methods: We randomly assigned a total of 188 patients with acute decompensated heart failure, worsened renal function, and persistent congestion to a strategy of stepped pharmacologic therapy (94 patients) or ultrafiltration (94 patients). The primary end point was the bivariate change from baseline in the serum creatinine level and body weight, as assessed 96 hours after random assignment. Patients were followed for 60 days.

Results: Ultrafiltration was inferior to pharmacologic therapy with respect to the bivariate end point of the change in the serum creatinine level and body weight 96 hours after enrollment (P=0.003), owing primarily to an increase in the creatinine level in the ultrafiltration group. At 96 hours, the mean change in the creatinine level was -0.04±0.53 mg per deciliter (-3.5±46.9 μmol per liter) in the pharmacologic-therapy group, as compared with +0.23±0.70 mg per deciliter (20.3±61.9 μmol per liter) in the ultrafiltration group (P=0.003). There was no significant difference in weight loss 96 hours after enrollment between patients in the pharmacologic-therapy group and those in the ultrafiltration group (a loss of 5.5±5.1 kg [12.1±11.3 lb] and 5.7±3.9 kg [12.6±8.5 lb], respectively; P=0.58). A higher percentage of patients in the ultrafiltration group than in the pharmacologic-therapy group had a serious adverse event (72% vs. 57%, P=0.03).

Conclusions: In a randomized trial involving patients hospitalized for acute decompensated heart failure, worsened renal function, and persistent congestion, the use of a stepped pharmacologic-therapy algorithm was superior to a strategy of ultrafiltration for the preservation of renal function at 96 hours, with a similar amount of weight loss with the two approaches. Ultrafiltration was associated with a higher rate of adverse events. (Funded by the National Heart, Lung, and Blood Institute; ClinicalTrials.gov number, NCT00608491.).

Figures

Figure 1
Figure 1. Changes in Serum Creatinine and Weight at 96 Hours (Bivariate Response)
The ellipses represent the 95% confidence regions and the stars the exact values for the mean changes in the serum creatinine level and weight at 96 hours in the ultrafiltration group and the pharmacologic-therapy group. Data from two patients who had been randomly assigned to the ultrafiltration group were excluded from the analysis: baseline creatinine measurements were missing for one patient, and all post-baseline creatinine measurements were missing for the other patient. To convert the values for creatinine to micromoles per liter, multiply by 88.4. To convert the values for weight to kilograms, multiply by 0.45.
Figure 2
Figure 2. Changes from Baseline in Serum Creatinine and Body Weight at Various Time Points, According to Treatment Group
The P values were calculated with the use of a Wilcoxon test. The data on creatinine levels reflect results from testing in local laboratories only.

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