Status:
COMPLETED
Ultrafiltration Versus Intravenous (IV) Diuretics for Patients Hospitalized for Acute Decompensated Heart Failure: (UNLOAD)
Lead Sponsor:
Nuwellis, Inc.
Conditions:
Congestive Heart Failure
Eligibility:
All Genders
18+ years
Phase:
NA
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 b...
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...
Eligibility Criteria
Inclusion
- Patients hospitalized with primary diagnosis of acute decompensated congestive heart failure (adCHF)
- Evidence of fluid overload as indicated by:
- pitting edema (2+) of lower extremities;
- jugular venous distension;
- pulmonary edema or pleural effusion;
- ascites;
- paroxysmal nocturnal dyspnea or 2-pillow orthopnea
Exclusion
- Acute coronary syndrome
- Creatinine greater than 3.0
- Systolic blood pressure less than or equal to 90 mmHg
- Hematocrit greater than 45%
- Prior administration of IV vasoactive drugs in the emergency room (ER)
- Clinical instability requiring pressors during hospitalization
- Recent use of iodinated contrast material
- Severe concomitant disease expected to prolong hospitalization
- Sepsis
- On or requires renal dialysis
- Had a cardiac transplant
- Heparin allergy
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
End Date :
October 1 2005
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00124137
Start Date
April 1 2004
End Date
October 1 2005
Last Update
March 15 2007
Active Locations (1)
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1
Midwest Heart Institute
Lombard, Illinois, United States, 60148