Heart Failure
Conditions
Brief summary
Slow continuous ultrafiltration using central vs peripheral line: feasibility of implementation, safety and efficacy in acute heart failure syndromes.
Interventions
PROCEDUREPeripheral line
Ultrafiltration therapy though peripheral line, two peripheral venous catheter will be placed in the arms.
PROCEDURECentral line vein
Ultrafiltration therapy through central line, a central venous catheter will be placed in internal jugular or femoral vein.
Sponsors
Parc de Salut Mar
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy | 48 hours after initiation of scuf therapy | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Security | 5th day of the study | 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. |
Countries
Spain
Outcome results
None listed