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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Nuria Ribas, Parc de Salut Mar Identifier:
First received: June 21, 2012
Last updated: April 25, 2016
Last verified: April 2016
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
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 Nuria Ribas, Parc de Salut Mar:

Primary Outcome Measures:
  • Efficacy [ Time Frame: 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:
  • Security [ Time Frame: 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.

Enrollment: 33
Study Start Date: November 2011
Estimated Study Completion Date: December 2016
Primary Completion Date: October 2013 (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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01630317

Cardiology Service, Hospital del Mar. Passeig Maritim 25-29,
Barcelona, Spain, 08003
Sponsors and Collaborators
Parc de Salut Mar
  More Information

Responsible Party: Nuria Ribas, Parc de Salut Mar Identifier: NCT01630317     History of Changes
Other Study ID Numbers: ULISES
Study First Received: June 21, 2012
Last Updated: April 25, 2016

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases processed this record on May 25, 2017