Ultrafiltration (Aquapheresis) in Patients With Leukemia and Severe Fluid Overload

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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 Blood containing too much salt and water is withdrawn from the body using catheters (sterile flexible tubes) and passed through a special filter.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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Treatments: Diuretics; Furosemide

Criteria

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.