Problem Heart failure with cardiorenal syndrome
Format Randomised, non-blinded
Treatment Venovenous ultrafiltration
Control Diuretic-based stepped pharmacologic therapy
Population 188 patients
Inclusion criteria -age 18 or older
-admitted to the hospital with a primary diagnosis of decompensated heart failure
-onset of cardiorenal syndrome after hospitalization or pre-hospitalization
--after hospitalization—onset of cardiorenal syndrome after hospitalization must occur within 10 days from the time of admission after receiving IV diuretics
--pre-hospitalization—onset of cardiorenal syndrome pre-hospitalization must occur within 12 weeks of the index hospitalization in the setting of escalating doses of outpatient diuretics
-persistent volume overload
--for patients with a pulmonary artery catheter, persistent volume overload will
includepulmonary capillary wedge pressure greater than 22mmHg and one of
the following clinical signs:
---at least 2+ peripheral edema and/or
---pulmonary edema or pleural effusions on chest x-ray
-- for patients without a pulmonary artery catheter, persistent volume overload will
include at least two of the following:
---at least 2+ peripheral edema
---jugular venous pressure greater than 10 cm on physical examination (or
central venous pressure greater than 10 mmHg when measured)
---pulmonary edema or pleural effusions on chest x-ray
Exclusion criteria intravascular volume depletion based on investigator’s clinical assessment
-acute coronary syndrome within 4 weeks
-indication for hemodialysis
-creatinine > 3.5 mg per deciliter at admission to the hospital
-systolic blood pressure < 90 mmHg at the time of enrollment
-alternative explanation for worsening renal function such as obstructive nephropathy,
-contrast induced nephropathy, acute tubular necrosis
-Hematocrit > 45%
-poor venous access
-clinical instability likely to require the addition of intravenous vasoactive drugs,
vasodilators and/or inotropic agents
-allergy or contraindications to the use of heparin
-the use of iodinated radio contrast material in the last 72 hours or anticipated use of IV
-contrast during the current hospitalization
-known bilateral renal artery stenosis
-active myocarditis
-hypertrophic obstructive cardiomyopathy
-severe valvular stenosis
-complex congenital heart disease
-sepsis or ongoing systemic infection
-enrollment in another clinical trial involving medical or device based interventions
Follow-up 60 days
Primary endpoint Change in the serum creatinine level and the change in weight, considered as a bivariate response, between the time of randomization and 96 hours after randomization.
Secondary endpoint(s) Rate of clinical decongestion and measures of global well-being and dyspnoea
Clinical decongestion was defined as jugular venous pressure of less than 8 cm of water, no more than trace peripheral edema, and the absence of orthopnoea.
Global well-being and dyspnoea were assessed with the use of a visual-analogue scale that ranged from 0 to 100, with higher scores indicating greater well-being and less severity of dyspnoea, respectively.
Details .
Brief summary: Ultrafiltration inferior to diuretics in cardiorenal syndrome
PAPER: Ultrafiltration in Decompensated Heart Failure with Cardiorenal Syndrome
Date 6 Nov 2012
Journal N Engl J Med. 2012 Nov 6.
Information Ultrafiltration vs. stepped pharmacologic therapy in cardiorenal syndrome
-Increased serum creatinine at 96hrs (P=0.003)
-No significant difference in weight loss
-Increased serious adverse events
Pharmacologic therapy included continuous infusion of diuretics +-metolazone +-vasoactive therapy