A Feasibility Study on Ultrafiltration and Blood Volume Measurements
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- 2. Evaluate if changes in blood volume, as measured by BVA, correlate with changes in HCT as measured by the device embedded in the Aquadex FlexFlow System ultrafiltration device
研究概览
简要总结
The objective of this feasibility study is to characterize the performance of the Aquadex FlexFlow® System with the hematocrit (HCT) feature in conjunction with Daxor's blood volume analyzer (BVA-100). The study will monitor blood volume changes during ultrafiltration (UF) therapy as a potential means to guide the removal of fluid in subjects hospitalized with acute decompensated heart failure (ADHF).
详细描述
The study will measure blood volumes at various time intervals using the BVA-100 for comparison to corresponding readings of hematocrit (HCT) levels from the Aquadex FlexFlow HCT sensor. Establishing a correlation between BVA measurements (off-line measurements) and HCT sensor measurements (on-line measurements) may enable the use of the BVA-100 to guide ultrafiltration therapy by the Aquadex system for fluid removal.
BVA-100 measurements would be used at baseline to accurately determine patient suitability for fluid removal and while HCT measurements would be used to monitor blood volume changes during ultrafiltration therapy, potentially guiding the removal of fluid in subjects hospitalized with ADHF.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older
- •Subject or legally authorized representative is able to provide appropriate consent to participate
- •Hospitalized for ADHF with fluid overload as indicated by at least two of the following:
- •Pitting edema ≥ 2+ of the lower extremities
- •Jugular venous distention > 8 cm
- •Pulmonary edema/pleural effusion on chest x-ray
- •Paroxysmal nocturnal dyspnea or ≥ two- pillow orthopnea
- •Respiration rate ≥ 20 per minute
排除标准
- •Unable or unwillingness to provide informed consent or to comply with study requirements
- •Subject who is pregnant
- •Acute coronary syndrome
- •Known bilateral renal artery stenosis
- •Serum creatinine > 3.0 mg/dL at the time of presentation
- •Subject receiving ongoing active treatment with diuretics (up to 2 doses of IV diuretics are permitted before initiation of ultrafiltration therapy)
- •Systolic blood pressure ≤ 90 mmHg
- •Poor or unattainable central access
- •Has bleeding disorder
- •Contraindications to systemic anticoagulation
- •Allergic to iodine, albumin, or iodinated I-131 albumin
- •Active myocarditis or hypertrophic obstructive cardiomyopathy
- •Severe uncorrected valvular stenosis
- •Complex congenital heart disease
- •Systemic infection
- •Previous organ transplant
- •Enrollment in other clinical trials
- •Life expectancy ≤ 6 months
结局指标
主要结局
2. Evaluate if changes in blood volume, as measured by BVA, correlate with changes in HCT as measured by the device embedded in the Aquadex FlexFlow System ultrafiltration device
时间窗: Through study procedure completion, average of 2 weeks
A correlation between BVA measured change in blood volume to changes in hematocrit (HCT) as measured by the online HCT sensor embedded in the Aquadex Flexflow system will be determined.
1. Evaluate changes in blood volume as measured by BVA from before initiation until completion of extracorporeal fluid removal by ultrafiltration
时间窗: Through study procedure completion, average of 2 weeks
BVA will be used to evaluate changes in blood volume from baseline (i.e., before initiation) until completion of extracorporeal fluid removal by ultrafiltration.
3. Evaluate the temporal relationship between changes in blood volume, as measured by BVA , and changes in clinical signs and symptoms of fluid overload
时间窗: Through study procedure completion, average of 2 weeks
Temporal relationship between blood volume change (as measured by the BVA) and changes in clinical signs and symptoms of fluid overload will be evaluated.
6. Change in urinary sodium concentration from baseline to ultrafiltration completion
时间窗: Through study procedure completion, average of 2 weeks
Urinary sodium concentration profile from baseline to ultrafiltration completion will be evaluated.
4. Evaluate the temporal relationship between changes in HCT, as measured by Aquadex HCT, and changes in clinical signs and symptoms of fluid overload
时间窗: Through study procedure completion, average of 2 weeks
Temporal relationship between HCT change (as measured by Aquadex HCT sensor) and changes in clinical signs and symptoms of fluid overload will be evaluated.
5. Total net fluid loss prior to hospital discharge
时间窗: Daily during study procedure, average of 2 weeks
The total net fluid removed during the ultrafiltration therapy will be evaluated.
8. Adverse events of special interest
时间窗: through study completion, average of 1 year
* Acute coronary syndrome * Bleeding (requiring blood transfusion or drop of hemoglobin \>3g/dl) * Catheter-related bloodstream infections * Hypotension necessitating intervention
7. Change in biomarkers from baseline until discharge:
时间窗: through study completion, average of 2 weeks
* Comprehensive Metabolic Panel (CMP)/Basic Metabolic Panel (BMP) * N-terminal proB- type natriuretic peptide (NT-proBNP) * Troponin-I * Urine Nephrocheck
次要结局
未报告次要终点