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

NCT ID: NCT01630317

Last Updated: 2016-04-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2016-12-31

Brief Summary

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

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Peripheral acces

Group Type: EXPERIMENTAL

Peripheral line

Intervention Type: PROCEDURE

Ultrafiltration therapy though peripheral line, two peripheral venous catheter will be placed in the arms.

Central access

Group Type: PLACEBO_COMPARATOR

Central line vein

Intervention Type: PROCEDURE

Ultrafiltration therapy through central line, a central venous catheter will be placed in internal jugular or femoral vein.

Interventions

Peripheral line

Ultrafiltration therapy though peripheral line, two peripheral venous catheter will be placed in the arms.

Intervention Type: PROCEDURE

Central line vein

Ultrafiltration therapy through central line, a central venous catheter will be placed in internal jugular or femoral vein.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Parc de Salut Mar

OTHER

Sponsor Role: lead

Responsible Party

Nuria Ribas

Nuria Ribas

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cardiology Service, Hospital del Mar. Passeig Maritim 25-29,

Barcelona, Barcelona, Spain

Countries

Spain

Other Identifiers

ULISES

Identifier Type: -

Identifier Source: org_study_id