Bioimpedance and Hand-held Echocardiographay for Clinical Decision-making in Treatment of Cardio-… (NCT02959281) | Clinical Trial Compass
WithdrawnNot Applicable
Bioimpedance and Hand-held Echocardiographay for Clinical Decision-making in Treatment of Cardio-renal Syndrome Type I
Stopped: Enrollement failure
0Started 2018-06-01
Plain-language summary
The purpose of this study is to investigate whether hemodynamic data obtained by a noninvasive bio-impedance system (NICAS) sampled from patients with cardiorenal syndrome type I (CRS1) improve clinical outcomes. We hypothesize that hemodynamic data provided to the caring physician will improve management of CRS1 patients.
Who can participate
Age range40 Years – 90 Years
SexALL
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Inclusion Criteria:
* Patient admitted for acute decompensation of heart failure and developed cardiorenal syndrome (all three criteria below are required):
A. Evidence of heart failure defined by either (i) or (ii) and (iii), where:
(i) is clinical complaints of dyspnea or leg swelling or fatigue (ii) is clinical findings of pulmonary rales, leg edema, or congestion on chest film (iii) is recent (within 1 year of admission) echocardiographic examination demonstrating heart failure B. Patient as in A (above) whos serum creatinine level on admission is 0.3 mg% greater than patient's baseline.
C. Patient capable of submitting informed consent
Exclusion Criteria:
* Other causes for dyspnea or leg edema (e.g. exacerbation of COPD, pneumonia, liver cirrhosis, hypoalbuminemia, nephrotic syndrome)
* other causes for acute renal failure (e.g. contrast media nephropathy 10 days prior to admission, use of NSAIDS or antibiotics (aminoglycosides, quinolones), diarrhea, vomiting, rhabdomyolysis, seizures, sepsis.
* Anemia (Hb\<8 gr%)
* significant bleeding (upper or lower GI, hemoptysis)
* BMI\>40, or BMI\<18
* Signs of a new myocardial infarction by EKG, and increase in troponin levels to levels 1.5 above baseline levels.
* Hypothyroidism
* Addison's disease
* patient on Hemo- or peritoneal dialysis
* Mechanical ventillation