A Feasibility Study on Ultrafiltration and Blood Volume Measurements
Stopped early · Not applicable
Conditions studied: Acute Decompensated Heart Failure, Fluid Overload
In brief
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).
Key facts
- Study ID
- NCT04241718
- Run by
- Nuwellis, Inc.
- People needed
- 6
- Starts
- 2019-12-19
- Expected to finish
- 2022-12-27
- Last updated by the study team
- 2024-11-14
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Midwest Cardiovascular Institute — Naperville, Illinois, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.