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

Not Applicable

• Conditions: Heart Failure
• Interventions: Procedure: Central line vein; Procedure: Peripheral line

• Registration Number: NCT01630317
• Lead Sponsor: Parc de Salut Mar

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2012-06-21
• Study First Submitted QC: 2012-06-26
• Study First Posted: 2012-06-28
• Primary Completion: 2013-10
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-25
• Last Update Posted: 2016-04-26
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 33

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Central access	Central line vein	-
Peripheral acces	Peripheral line	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Cardiology Service, Hospital del Mar. Passeig Maritim 25-29,; 🇪🇸 Barcelona, Spain