LeukemiaNCT01508260
Ultrafiltration (Aquapheresis) in Patients With Leukemia and Severe Fluid Overload
A study testing Aquapheresis and Furosemide in people with Leukemia, run by M.D. Anderson Cancer Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia
- What is being tested?
- Aquapheresis and Furosemide
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2013to Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Ultrafiltration (Aquapheresis) in the Management of Patients With Leukemia and Severe Fluid Overload
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.
Read the 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 will be enrolled in the Pilot portion of the study. The next group of up to 40 participants will be enrolled in the Randomized portion of the study.
In the Pilot portion of the study, researchers want to learn about the safety and level of effectiveness of aquapheresis in leukemia patients with severe fluid overload who do not respond to diuretics.
If you are in the Randomized portion of the study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 groups. You will have an equal chance of being assigned to each group.
- Group A will receive aquapheresis.
- Group B will receive furosemide. The doctor will discuss this with you.
If you are in Group A, you will be connected to the aquapheresis pump through an intravenous (IV) catheter placed in your forearm. The pump looks like the ones used to infuse IV drugs. It will hang on a pole by your bed. About 6 teaspoons of your 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.
If you are in Group B, you will receive one of the following for as the doctor thinks it is needed (until most of the excess fluid is removed):
- furosemide by vein over about 15 minutes every 8 hours
- furosemide by vein as a continuous (non-stop) infusion
Both Groups:
If the doctor thinks it is needed, you will be given other standard of care drugs such as albumin and metolazone to help your kidneys to make more urine. The study staff will tell you about these drugs, how they will be given, and the possible risks.
Study Visits:
Every day while you are receiving aquapheresis or diuretic treatment:
- You will be asked about any symptoms you may be having.
- You will have a physical exam, including measurement of your vital signs (blood pressure, heart rate, and breathing rate) and weight.
- You will be asked how much you drank. The study staff will measure how much you urinate.
- Your leg will be measured for swelling due to fluid retention.
At least every other day, blood (about 4 teaspoons) will be drawn for routine tests.
If the doctor thinks it is needed, you will have a chest x-ray on Day 3.
Length of Participation:
If you are in Group A, you will remain on study treatment for as long as the doctor thinks it is needed (possibly about 1-7 days).
If you are in Group B, you will receive standard treatment for as long as your doctor thinks it is needed.
You will no longer be able to receive the study treatment (Group A) or you will be taken off study (Group B) if intolerable side effects occur or if you are unable to follow study directions.
Your participation on the study will be over once you have completed the end-of-study follow-up visit.
End-of-Treatment Visit:
After you stop taking the study treatment or standard treatment, the following tests and procedures will be performed:
- You will be asked about any symptoms you may be having.
- You will have a physical exam, including measurement of your vital signs and weight.
- You will be asked how much you drank. The study staff will measure how much you urinate.
- Your leg will be measured for swelling due to fluid retention.
- Blood (about 4 teaspoons) will be drawn for routine tests.
- If the doctor thinks it is needed, you will have a chest x-ray.
End-of-Study Follow-up Visit:
At 30 days after the end of study therapy:
- You will have a physical exam, including measurement of your vital signs and weight.
- You will be asked about any symptoms you may be having.
- Your leg will be measured for swelling due to fluid retention.
This is an investigational study. The Aquadex FlexFlow™ Fluid Removal Systems pump used for aquapheresis is FDA approved and commercially available for patients with fluid overload. Using the Aquadex FlexFlow™ Fluid Removal Systems pump in patients with leukemia to remove excess fluid is investigational. Furosemide is FDA approved and commercially available for other uses such as the treatment of swelling caused by heart failure or kidney or liver problems.
Up to 50 patients will be enrolled in this study. All will be enrolled at MD Anderson.
- Conditions
- Leukemia
- Being tested
- Aquapheresis, Furosemide
- 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
- Medical subject headings
- Leukemia, Edema, Dyspnea, Dyspnea, Paroxysmal, Respiratory Sounds, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AquapheresisProcedure or surgery
Also called Aquadex pump
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.
FurosemideDrug
Also called Furomide, Lasix
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Aquapheresis |
| Diuretics | Active comparator | Furosemide by vein over about 15 minutes every 8 hours or by vein as a continuous (non-stop) infusion. Receives: Drug: Furosemide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 72 hours
Secondary outcomes (1)
Complete Response
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.
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2012 (estimated)
- Study startMar 2013
- Primary completionMar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gloria Iliescu, MD, Principal investigator, UT MD Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01508260
- Sponsor's protocol ID
- 2011-0475
- Status last verified
- Apr 2013
- First submitted
- 9 Jan 2012
- Last updated
- 5 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrafiltration (Aquapheresis) in the Management of Patients With Leukemia and Severe Fluid Overload
- ClinicalTrials.gov ID
- NCT01508260
- Acronym / sponsor ID
- 2011-0475
- Conditions
- Leukemia
- Keywords
- Leukemia, Aquapheresis, Ultrafiltration, Aquadex pump, Severe Fluid Overload, Diuretic therapy, Dyspnea, Orthopnea
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Mar 2018 (estimated)
- First posted
- 11 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 will be enrolled in the Pilot portion of the study. The next group of up to 40 participants will be enrolled in the Randomized portion of the study.
In the Pilot portion of the study, researchers want to learn about the safety and level of effectiveness of aquapheresis in leukemia patients with severe fluid overload who do not respond to diuretics.
If you are in the Randomized portion of the study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 groups. You will have an equal chance of being assigned to each group.
- Group A will receive aquapheresis.
- Group B will receive furosemide. The doctor will discuss this with you.
If you are in Group A, you will be connected to the aquapheresis pump through an intravenous (IV) catheter placed in your forearm. The pump looks like the ones used to infuse IV drugs. It will hang on a pole by your bed. About 6 teaspoons of your 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.
If you are in Group B, you will receive one of the following for as the doctor thinks it is needed (until most of the excess fluid is removed):
- furosemide by vein over about 15 minutes every 8 hours
- furosemide by vein as a continuous (non-stop) infusion
Both Groups:
If the doctor thinks it is needed, you will be given other standard of care drugs such as albumin and metolazone to help your kidneys to make more urine. The study staff will tell you about these drugs, how they will be given, and the possible risks.
Study Visits:
Every day while you are receiving aquapheresis or diuretic treatment:
- You will be asked about any symptoms you may be having.
- You will have a physical exam, including measurement of your vital signs (blood pressure, heart rate, and breathing rate) and weight.
- You will be asked how much you drank. The study staff will measure how much you urinate.
- Your leg will be measured for swelling due to fluid retention.
At least every other day, blood (about 4 teaspoons) will be drawn for routine tests.
If the doctor thinks it is needed, you will have a chest x-ray on Day 3.
Length of Participation:
If you are in Group A, you will remain on study treatment for as long as the doctor thinks it is needed (possibly about 1-7 days).
If you are in Group B, you will receive standard treatment for as long as your doctor thinks it is needed.
You will no longer be able to receive the study treatment (Group A) or you will be taken off study (Group B) if intolerable side effects occur or if you are unable to follow study directions.
Your participation on the study will be over once you have completed the end-of-study follow-up visit.
End-of-Treatment Visit:
After you stop taking the study treatment or standard treatment, the following tests and procedures will be performed:
- You will be asked about any symptoms you may be having.
- You will have a physical exam, including measurement of your vital signs and weight.
- You will be asked how much you drank. The study staff will measure how much you urinate.
- Your leg will be measured for swelling due to fluid retention.
- Blood (about 4 teaspoons) will be drawn for routine tests.
- If the doctor thinks it is needed, you will have a chest x-ray.
End-of-Study Follow-up Visit:
At 30 days after the end of study therapy:
- You will have a physical exam, including measurement of your vital signs and weight.
- You will be asked about any symptoms you may be having.
- Your leg will be measured for swelling due to fluid retention.
This is an investigational study. The Aquadex FlexFlow™ Fluid Removal Systems pump used for aquapheresis is FDA approved and commercially available for patients with fluid overload. Using the Aquadex FlexFlow™ Fluid Removal Systems pump in patients with leukemia to remove excess fluid is investigational. Furosemide is FDA approved and commercially available for other uses such as the treatment of swelling caused by heart failure or kidney or liver problems.
Up to 50 patients will be enrolled in this study. All will be enrolled at MD Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pilot Phase Aquapheresis | Experimental | Procedure: AquapheresisThe 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. |
| Aquapheresis | Experimental | Procedure: AquapheresisParticipant 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. |
| Diuretics | Active comparator | Drug: FurosemideFurosemide by vein over about 15 minutes every 8 hours or by vein as a continuous (non-stop) infusion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AquapheresisAlso: Aquadex pumpParticipant 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. | Procedure or surgery | Aquapheresis, Pilot Phase Aquapheresis |
| FurosemideAlso: Furomide, Lasix20-40 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. | Drug | Diuretics |
Primary outcome
Safety and Efficacy of Aquapheresis versus Diuretic Therapy
Time frame: 72 hours
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.
1 secondary outcome
Complete Response
Time frame: 72 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2013.
- UT MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gloria Iliescu, MD principal investigator
UT MD Anderson Cancer Center
Questions about this trial
What is this clinical trial studying?
A study testing Aquapheresis and Furosemide in people with Leukemia, run by M.D. Anderson Cancer Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 5 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Efficacy of Aquapheresis versus Diuretic Therapy (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2013.