Ultrafiltration (Aquapheresis) in Patients With Leukemia and Severe Fluid Overload
This study has been withdrawn prior to enrollment.
Sponsor:
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01508260
First received: January 9, 2012
Last updated: April 4, 2013
Last verified: April 2013
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Purpose
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 Blood containing too much salt and water is withdrawn from the body using catheters (sterile flexible tubes) and passed through a special filter.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.
| Condition | Intervention |
|---|---|
|
Leukemia |
Procedure: Aquapheresis Drug: Furosemide |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Ultrafiltration (Aquapheresis) in the Management of Patients With Leukemia and Severe Fluid Overload |
Resource links provided by NLM:
Further study details as provided by M.D. Anderson Cancer Center:
Primary Outcome Measures:
- Safety and Efficacy of Aquapheresis versus Diuretic Therapy [ Time Frame: 72 hours ] [ Designated as safety issue: Yes ]Primary end point is success rate defined as achievement of weight loss of 7 pounds or 50% of weight gain, whichever is greater without >/=100% increase of baseline creatinine at 72 hours.
Secondary Outcome Measures:
- Complete Response [ Time Frame: 72 hours ] [ Designated as safety issue: Yes ]Complete response defined as achievement of 80% removal of fluid overload compared to dry body weight (average body weight before being sick and hospitalized) without ≥100% increase of baseline creatinine at 72 hours.
| Enrollment: | 0 |
| Study Start Date: | March 2013 |
| Estimated Primary Completion Date: | March 2018 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Pilot Phase Aquapheresis
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.
|
Procedure: Aquapheresis
Participant connected to aquapheresis pump through an intravenous (IV) catheter placed in forearm. Average treatment is about 24 hours but can extend up to 7 days.
Other Name: Aquadex pump
|
|
Experimental: Aquapheresis
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.
|
Procedure: Aquapheresis
Participant connected to aquapheresis pump through an intravenous (IV) catheter placed in forearm. Average treatment is about 24 hours but can extend up to 7 days.
Other Name: Aquadex pump
|
|
Active Comparator: Diuretics
Furosemide by vein over about 15 minutes every 8 hours or by vein as a continuous (non-stop) infusion.
|
Drug: Furosemide
20-40 mg by vein every 8 hours as indicated for optimal diuresis to achieve negative fluid balance or 0.5 to 5 mg per hour by continuous infusion.
Other Names:
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Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01508260 History of Changes |
| Other Study ID Numbers: | 2011-0475 |
| Study First Received: | January 9, 2012 |
| Last Updated: | April 4, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by M.D. Anderson Cancer Center:
|
Leukemia Aquapheresis Ultrafiltration Aquadex pump Severe Fluid Overload Diuretic therapy Dyspnea Orthopnea Paroxysmal nocturnal dyspnea |
PND Peripheral edema Rales Jugular venous distension JVD Hypoxia Pulmonary edema by chest X-ray Furosemide Lasix |
Additional relevant MeSH terms:
|
Leukemia Water Intoxication Neoplasms by Histologic Type Neoplasms Water-Electrolyte Imbalance Metabolic Diseases Poisoning Substance-Related Disorders Diuretics |
Furosemide Natriuretic Agents Physiological Effects of Drugs Pharmacologic Actions Sodium Potassium Chloride Symporter Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Cardiovascular Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013