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

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

Study Overview

• Status: Unknown
• Conditions: Heart Failure
• Intervention / Treatment: Procedure: Peripheral line; Procedure: Central line vein

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08003
    • Cardiology Service, Hospital del Mar. Passeig Maritim 25-29,

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Parc de Salut Mar

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): October 1, 2013
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: June 21, 2012
• First Submitted That Met QC Criteria: June 26, 2012
• First Posted (Estimate): June 28, 2012

Study Record Updates

• Last Update Posted (Estimate): April 26, 2016
• Last Update Submitted That Met QC Criteria: April 25, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: ULISES