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

This study has been withdrawn prior to enrollment.
Sponsor:
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
  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 Blood containing too much salt and water is withdrawn from the body using catheters (sterile flexible tubes) and passed through a special filter.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:
  • Furomide
  • Lasix

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01508260

Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Gloria Iliescu, MD UT MD Anderson Cancer Center
  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
Neoplasms by Histologic Type
Neoplasms
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 August 28, 2014