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CARRESS-HF TRIAL |
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| 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 | |
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| 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 |