Clinical trial · Interventional
Ultrafiltration (Aquapheresis) in Patients With Leukemia and Severe Fluid Overload
Ultrafiltration (Aquapheresis) in the Management of Patients With Leukemia and Severe Fluid Overload
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this clinical research study is to learn about the safety and level of effectiveness of aquapheresis compared to diuretic drugs. Diuretic drugs are designed to help the kidneys to form more urine. They also remove fluids from patients with severe fluid overload who have not responded to diuretics. Aquapheresis is a procedure that removes excess fluid from the body. Blood containing too much salt and water is withdrawn from the body using catheters (sterile flexible tubes) and passed through a special filter. The filter separates the excess salt and water from the blood. The blood is returned to the patient and the fluid is collected in a bag to be disposed. Aquapherisis may benefit patients by removing excess fluid and salt from the body.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Aquapheresis | Procedure | — | UNRESOLVED |
| Furosemide | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Pilot Phase Aquapheresis
- description
- The first portion of this study is an open label pilot experience to evaluate the safety of aquapheresis in leukemia patients with severe fluid overload non-responsive to diuretics. A total of 10 patients will be treated.
- interventionNames
- Procedure: Aquapheresis
- type
- EXPERIMENTAL
- label
- Aquapheresis
- description
- Participant connected to aquapheresis pump through an intravenous (IV) catheter placed in forearm. About 6 teaspoons of blood will flow through the blood circuit, and the excess fluid will slowly be collected in the collection bag. The exact length of time of aquapheresis treatment is determined by how much fluid needs to be removed and how fast it can be removed. The average treatment is about 24 hours but can extend up to 7 days. About 6 liters or 13 pounds will be removed.
- interventionNames
- Procedure: Aquapheresis
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. All patients must be 18 years of age or older and have a diagnosis of leukemia and be hospitalized on leukemia floor or MICU 2. Weight gain of 10 pounds or more. 3. In addition, patients should have 2 or more signs and symptoms of fluid overload such as: dyspnea, orthopnea, paroxysmal nocturnal dyspnea (PND), peripheral edema, rales, jugular venous distension (JVD), hypoxia (pulse ox \< 90% on room air) and pulmonary edema by chest X-ray. 4. AND be poorly responsive to diuretics defined as positive fluid balance or \< 1% decrease in current body weight / 24 hours with use of furosemide 60 mg IV/24h. 5. Subjects will be eligible regardless of poor performance, organ dysfunctions, organ failures, or other criteria of decompensation and/or debilitation. 6. Subjects will be eligible regardless of platelet counts. 7. Patients may be on a regular floor or in the intensive care unit. 8. They may be on respiratory mechanical ventilation or not. Exclusion Criteria: 1. Indication for dialysis (as judged necessary by nephrology (hyperkalemia, acidosis). 2. AKI defined as 100% increase in baseline creatinine. 3. Hypotension (SBP \< 90mmHg). 4. Pregnant or breastfeeding women are excluded.
References
Publications (0)
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