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

This study is currently recruiting participants.
Verified November 2013 by Parc de Salut Mar
Sponsor:
Information provided by (Responsible Party):
Parc de Salut Mar
ClinicalTrials.gov Identifier:
NCT01630317
First received: June 21, 2012
Last updated: November 20, 2013
Last verified: November 2013
  Purpose

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


Condition Intervention
Heart Failure
Procedure: Peripheral line
Procedure: Central line vein

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Slow Continuous Ultrafiltration Using Central vs Peripheral Line: Feasibility of Implementation, Safety and Efficacy in Acute Heart Failure Syndromes.

Resource links provided by NLM:


Further study details as provided by Parc de Salut Mar:

Primary Outcome Measures:
  • Efficacy [ Time Frame: 48 hours after initiation of scuf therapy ] [ Designated as safety issue: No ]
    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:
  • Security [ Time Frame: 5th day of the study ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 50
Study Start Date: November 2011
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01630317

Contacts
Contact: Nuria Ribas, MD 0034 93 248 3118 60055@parcdesalutmar.cat
Contact: Cristina Enjuanes, MD 0034 93 248 31 20 60448@parcdesalutmar.cat

Locations
Spain
Cardiology Service, Hospital del Mar. Passeig Maritim 25-29, Recruiting
Barcelona, Spain, 08003
Principal Investigator: Nuria Ribas, MD         
Sponsors and Collaborators
Parc de Salut Mar
  More Information

No publications provided

Responsible Party: Parc de Salut Mar
ClinicalTrials.gov Identifier: NCT01630317     History of Changes
Other Study ID Numbers: ULISES
Study First Received: June 21, 2012
Last Updated: November 20, 2013
Health Authority: Spain: Comité Ético de Investigación Clínica

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 14, 2014