Ultrafiltration Versus Intravenous (IV) Diuretics for Patients Hospitalized for Acute Decompensated Heart Failure: (UNLOAD)

• Status: Completed
• Trial end date: 2005-10-01
• Target enrollment: 0
• Participant gender: All

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 patient's breathing.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CHF Solutions; Nuwellis, Inc.
• Treatments: Diuretics

Criteria

Inclusion Criteria:

• Patients hospitalized with primary diagnosis of acute decompensated congestive heart failure (adCHF)

• Evidence of fluid overload as indicated by:

1. pitting edema (2+) of lower extremities;

2. jugular venous distension;

3. pulmonary edema or pleural effusion;

4. ascites;

5. paroxysmal nocturnal dyspnea or 2-pillow orthopnea

Exclusion Criteria:

• 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