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. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 20, 2014