Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00124137
Status:
COMPLETED
Last Update Posted:
2007-03-15
First Post:
2005-07-25
Brief Title:
Ultrafiltration Versus Intravenous IV Diuretics for Patients Hospitalized for Acute Decompensated Heart Failure UNLOAD
Sponsor:
Nuwellis Inc
Organization:
Nuwellis Inc
Study Overview
Official Title:
Ultrafiltration Versus IV Diuretics for Patients Hospitalized for Acute Decompensated Heart Failure A Prospective Randomized Clinical Trial
Status:
COMPLETED
Status Verified Date:
2005-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to compare patients who are suffering from heart failure and who are fluid overloaded to determine if ultrafiltration UF can remove more of the extra fluid as measured by weight loss while in the hospital and improve the patients breathing
Detailed Description:
Congestive heart failure is an important public health issue It remains the leading cause of hospitalization in Medicare beneficiaries Ninety percent of all hospitalizations for CHF are due to fluid overload Most of the expense related to the management of heart failure is due to hospital-based care interventions that reduce the amount of time patients spend in the hospital may greatly decrease the cost associated with caring for these patients
Hospital stay for patients admitted for acute decompensated congestive heart failure adCHF is largely dictated by how quickly the signs and symptoms of congestion can be relieved and whether ACE inhibitors can be started safely Diuretics are usually effective in relieving congestion but achieving adequate diuresis often requires a process of trial and error Some patients are simply refractory to oral or intravenous diuretics Diuretics stimulate adverse neurohormonal systems and can cause progressive azotemia Bayliss 1977 showed that there is a significant increase in renin and aldosterone levels as a response to diuretic treatment rather than as a result of the heart failure itself Gottlieb 2002 showed that loop diuretics diminish glomerular filtration rate in patients with heart failure In addition as more diuretics are given serum electrolyte imbalances often occur requiring additional monitoring of patients
UF has been used as a therapeutic method to remove excessive fluid in patients for over 30 years UF removes excess water without causing a significant clinical change in the electrolyte composition of the blood or causes adverse affects on the kidneys and neurohormonal system Studies have shown that UF increases urine output increases responsiveness to standard oral therapies and decreases readmission rate While the usefulness of UF in this patient population has great potential this form of therapy is not usually performed due to the need for invasive venous access and increased expense ie high flow dialysis machines CHF Solutions has developed the Aquadex System that has FDA market clearance for UF The advantage of the Aquadex System is its simplicity and the fact that it can be administered by means of peripheral catheters or with a central venous access Early prospective series and subsequent clinical experience involving adCHF patients have shown that 4 to 8 liters can easily be withdrawn in a short amount of time using the peripheral access approach with the Aquadex System Volume removal was not associated with disruption of electrolyte balance worsening of renal distress or impact on blood pressure or heart rate of clinical significance The Aquadex System is a predictable safe and effective way to ensure adequate volume removal that may result in shorter hospital stays better symptom relief and more efficient dosing of medications for the treatment of adCHF
The purpose of this study is to determine whether the Aquadex System can improve the acute management of patients with adCHF and maintain this improvement over a period of time compared to IV diuretics Ultrafiltration in this patient population may decrease length of hospital stay and reduce hospital readmissions for heart failure leading to a significant reduction in costs for the treatment of these patients
Hospital stay for patients admitted for acute decompensated congestive heart failure adCHF is largely dictated by how quickly the signs and symptoms of congestion can be relieved and whether ACE inhibitors can be started safely Diuretics are usually effective in relieving congestion but achieving adequate diuresis often requires a process of trial and error Some patients are simply refractory to oral or intravenous diuretics Diuretics stimulate adverse neurohormonal systems and can cause progressive azotemia Bayliss 1977 showed that there is a significant increase in renin and aldosterone levels as a response to diuretic treatment rather than as a result of the heart failure itself Gottlieb 2002 showed that loop diuretics diminish glomerular filtration rate in patients with heart failure In addition as more diuretics are given serum electrolyte imbalances often occur requiring additional monitoring of patients
UF has been used as a therapeutic method to remove excessive fluid in patients for over 30 years UF removes excess water without causing a significant clinical change in the electrolyte composition of the blood or causes adverse affects on the kidneys and neurohormonal system Studies have shown that UF increases urine output increases responsiveness to standard oral therapies and decreases readmission rate While the usefulness of UF in this patient population has great potential this form of therapy is not usually performed due to the need for invasive venous access and increased expense ie high flow dialysis machines CHF Solutions has developed the Aquadex System that has FDA market clearance for UF The advantage of the Aquadex System is its simplicity and the fact that it can be administered by means of peripheral catheters or with a central venous access Early prospective series and subsequent clinical experience involving adCHF patients have shown that 4 to 8 liters can easily be withdrawn in a short amount of time using the peripheral access approach with the Aquadex System Volume removal was not associated with disruption of electrolyte balance worsening of renal distress or impact on blood pressure or heart rate of clinical significance The Aquadex System is a predictable safe and effective way to ensure adequate volume removal that may result in shorter hospital stays better symptom relief and more efficient dosing of medications for the treatment of adCHF
The purpose of this study is to determine whether the Aquadex System can improve the acute management of patients with adCHF and maintain this improvement over a period of time compared to IV diuretics Ultrafiltration in this patient population may decrease length of hospital stay and reduce hospital readmissions for heart failure leading to a significant reduction in costs for the treatment of these patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None