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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 currently recruiting participants.
Verified June 2012 by Parc de Salut Mar
Sponsor:
Information provided by (Responsible Party):
Magi Farre, Parc de Salut Mar
ClinicalTrials.gov Identifier:
NCT01630317
First received: June 21, 2012
Last updated: February 12, 2013
Last verified: June 2012
History of Changes

June 21, 2012
February 12, 2013
November 2011
December 2013   (final data collection date for primary outcome measure)
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
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 acces against a group of patients with the same features treated by central acces. This outcome will be measured by patient global assessment
Complete list of historical versions of study NCT01630317 on ClinicalTrials.gov Archive Site
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.
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 unbdertood as the worse punctuation for the AE). Every AE has a punctuation related to the seriousness.
Not Provided
Not Provided
 
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.

Slow continuous ultrafiltration using central vs peripheral line: feasibility of implementation, safety and efficacy in acute heart failure syndromes.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Heart Failure
  • Procedure: Peripheral line
    Ultrafiltration therapy though peripheral line, two peripheral venous catheter will be placed in the arms.
  • Procedure: Central line vein
    Ultrafiltration therapy through central line, a central venous catheter will be placed in internal jugular or femoral vein.
  • Experimental: Peripheral acces
    Intervention: Procedure: Peripheral line
  • Placebo Comparator: Central access
    Intervention: Procedure: Central line vein
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
January 2014
December 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Nuria Ribas, MD 0034 93 248 3118 60055@parcdesalutmar.cat
Contact: Cristina Enjuanes, MD 0034 93 248 31 20 60448@parcdesalutmar.cat
Spain
 
NCT01630317
ULISES
No
Magi Farre, Parc de Salut Mar
Parc de Salut Mar
Not Provided
Not Provided
Parc de Salut Mar
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP