NL-OMON56708招募中不适用
Fluid management of Acute decompensated heart failure Subjects Treated with Reprieve Decongestion Management System (DMS) - FASTR Trial - FASTR Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Hospitalized with a diagnosis of heart failure as defined by the presence of
- •at least 1 symptom (dyspnea, orthopnea, or edema/swelling) AND 1 sign
- •(peripheral edema, ascites, jugular venous distension).
- •2. >=10 lb (4.5 kg) above dry weight either by historical weights or as
- •estimated by health care provider.
- •3. Prior use of outpatient oral loop diuretics within 30 days prior to
- •4. Patients >= 18 years of age able to provide informed consent (or deferred
- •consent) and comply with study procedures.
排除标准
- •1. Inability to place Foley catheter or IV catheter or other urologic issues
- •that would predispose the patient to a high rate of urogenital trauma or
- •infection with catheter placement.
- •2. Hemodynamic instability as defined by any of the following: systolic blood
- •pressure <90 mmHg, use of vasopressors, use of IV inotropes to treat
- •hypotension (systolic blood pressure <90 mm Hg) or suspected/confirmed low
- •cardiac output/shock, mechanical circulatory support, uncontrolled arrhythmias,
- •active severe bleeding, or confirmed or suspected cardiogenic shock. Note: In
- •the absence of the above conditions, use of inotropes to augment diuresis is
- •3. Dyspnea due primarily to non-cardiac causes (e.g., severe chronic
- •obstructive pulmonary disease or pneumonia).
- •4. Acute infection with evidence of systemic involvement (e.g., clinically
- •suspected infection with fever or elevated serum white blood cell count).
- •5. Estimated glomerular filtration rate (eGFR) < 20 ml/min/1.73m2 calculated
- •using the MDRD equation or current use of renal replacement therapy (RRT).
- •6. Significant left ventricular outflow obstruction, uncorrected complex
- •congenital heart disease, known severe stenotic valvular disease, infiltrative
- •or constrictive cardiomyopathy, acute myocarditis, type 1 acute myocardial
- •infarction requiring treatment (within previous week), or any other pathology
- •that, in the opinion of the investigator, would make aggressive diuresis poorly
- •7. Inability to follow instructions or comply with follow-up procedures.
- •8. Other concomitant disease or condition that investigator deems unsuitable
- •for the study, including drug or alcohol abuse or psychiatric, behavioral or
- •cognitive disorders, sufficient to interfere with the patient*s ability to
- •understand and comply with the study instructions or follow-up procedures.
- •9. Severe electrolyte abnormalities (e.g., serum potassium <3.0 mEq/L,
- •magnesium <1.3 mEq/L or sodium <125 mEq/l). Note: These are based on
- •baseline/screening labs. Subjects whose electrolyte levels are repleted cannot
- •be reassessed for inclusion in the trial.
- •10. Presence of active COVID-19 infection.
- •11. Enrollment in another interventional trial during the trial participation.
- •12. Inability to return for follow-up study visits.
- •13. Life expectancy less than 3 months.
- •14. Women who are pregnant. Pregnancy must be ruled out and the patient must
- •make every effort not to become pregnant.
研究者
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