Slow Continuous Ultrafiltration Using Central vs Peripheral Line: Feasibility of Implementation, Safety and Efficacy in Acute Heart Failure Syndromes.

Study Overview
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Brief Summary
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Slow continuous ultrafiltration using central vs peripheral line: feasibility of implementation, safety and efficacy in acute heart failure syndromes.

Official Title
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Slow Continuous Ultrafiltration Using Central vs Peripheral Line: Feasibility of Implementation, Safety and Efficacy in Acute Heart Failure Syndromes.

Conditions
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Heart Failure

Intervention / Treatment
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* Procedure: Peripheral line
* Procedure: Central line vein


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥ 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. Exclusion Criteria: 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 Sepsis On or requires renal dialysis.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Peripheral acces<br> | Procedure: Peripheral line<br>* Ultrafiltration therapy though peripheral line, two peripheral venous catheter will be placed in the arms.<br>|
| Placebo Comparator: Central access<br> | Procedure: Central line vein<br>* Ultrafiltration therapy through central line, a central venous catheter will be placed in internal jugular or femoral vein.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy | Compare patient global improvement 48 hours after initiation of scuf therapy in a group of patients with the same features treated by peripheral access against a group of patients with the same features treated by central access. This outcome will be measured by patient global assessment | 48 hours after initiation of scuf therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Security | Compare complications in acute heart failure patients treated with scuf, in a group treated by peripheral line vs central line. This outcome will be assessed by a safety score at the AE at the 5th day of the study. ( 0 : no AE and 79 understood as the worse punctuation for the AE). Every AE has a punctuation related to the seriousness. | 5th day of the study |