Slow Continuous Ultrafiltration Using Central vs Peripheral Line: Feasibility of Implementation, Safety and Efficacy in Acute Heart Failure Syndromes.
This trial is active, not recruiting.
|Treatments||peripheral line, central line vein|
|Sponsor||Parc de Salut Mar|
|Start date||November 2011|
|End date||October 2013|
|Trial size||33 participants|
|Trial identifier||NCT01630317, ULISES|
Slow continuous ultrafiltration using central vs peripheral line: feasibility of implementation, safety and efficacy in acute heart failure syndromes.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
time frame: 48 hours after initiation of scuf therapy
time frame: 5th day of the study
Male or female participants at least 18 years old.
- ≥ 18 years
- Patients hospitalized with primary diagnosis of acute heart failure defined as ≥ 2 of the following criteria:
- Peripheral or sacral edema
- Jugular venous distension or venous central pressure > 10 mmHg
- Hepatomegaly or ascites
- Pulmonary edema or pleural effusion on x-ray or pulmonary wedge pressure or end-diastolic pressure > 20 mmHg.
- High pro-BNP
- Randomization during first 24 hours
- Serum creatinine levels < 3mg/dL, and K < 6 mmol/L
- The patient should be able to communicate with research staff and meet with study procedures.
- The patient will signed informed consent.
- Diagnosis of severe aortic stenosis or severe obstruction to the LVOT, tamponade, cardiac hypertrophic or restrictive cardiomyopathy.
- Impossibility of venous catheterization
- Acute coronary syndrome
- Creatinine greater than 3.0 or K greater than 6 mmol/L.
- Systolic blood pressure less than or equal to 100 mmHg
- Hematocrit greater than 45%
- Prior administration of IV vasoactive drugs in the emergency room (ER)
- Clinical instability requiring pressors during hospitalization
- On or requires renal dialysis.
|Official title||Slow Continuous Ultrafiltration Using Central vs Peripheral Line: Feasibility of Implementation, Safety and Efficacy in Acute Heart Failure Syndromes.|
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