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

NCT01508260 | Withdrawn DMC

• 1 other identifier: 2011-0475
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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 Blood containing too much salt and water is withdrawn from the body using catheters (sterile flexible tubes) and passed through a special filter.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

Leukemia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Safety and Efficacy of Aquapheresis versus Diuretic Therapy

  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.

  72 hours

Secondary Outcomes (1)

• Complete Response

  72 hours

Study Arms (3)

Pilot Phase Aquapheresis

EXPERIMENTAL

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

Aquapheresis

EXPERIMENTAL

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

Diuretics

ACTIVE COMPARATOR

Furosemide by vein over about 15 minutes every 8 hours or by vein as a continuous (non-stop) infusion.

Drug: Furosemide

Interventions

Aquapheresis PROCEDURE

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.

Also known as: Aquadex pump

Aquapheresis; Pilot Phase Aquapheresis

Furosemide DRUG

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.

Also known as: Furomide, Lasix

Diuretics

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Related Links

• UT MD Anderson Cancer Center Website

MeSH Terms

Conditions

Leukemia; Edema; Dyspnea; Dyspnea, Paroxysmal; Respiratory Sounds; Hypoxia

Interventions

Furosemide

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Heart Failure; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Sulfanilamides; Sulfonamides; Amides; Organic Chemicals; Aniline Compounds; Amines; Sulfones; Sulfur Compounds

Study Officials

• Gloria Iliescu, MD

  UT MD Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2012
• First Posted: January 11, 2012
• Study Start: March 1, 2013
• Primary Completion: March 1, 2018
• Last Updated: April 5, 2013

Record last verified: 2013-04