Status:
WITHDRAWN
Ultrafiltration (Aquapheresis) in Patients With Leukemia and Severe Fluid Overload
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Leukemia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 mor...
Detailed Description
Study Groups: If you are found to be eligible to take part in this study, you will be assigned to a study group based on when you join this study. The first group of 10 participants to join the study...
Eligibility Criteria
Inclusion
- All patients must be 18 years of age or older and have a diagnosis of leukemia and be hospitalized on leukemia floor or MICU
- Weight gain of 10 pounds or more.
- 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.
- 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.
- Subjects will be eligible regardless of poor performance, organ dysfunctions, organ failures, or other criteria of decompensation and/or debilitation.
- Subjects will be eligible regardless of platelet counts.
- Patients may be on a regular floor or in the intensive care unit.
- They may be on respiratory mechanical ventilation or not.
Exclusion
- Indication for dialysis (as judged necessary by nephrology (hyperkalemia, acidosis).
- AKI defined as 100% increase in baseline creatinine.
- Hypotension (SBP \< 90mmHg).
- Pregnant or breastfeeding women are excluded.
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01508260
Start Date
March 1 2013
Last Update
April 5 2013
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