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
Parc de Salut Mar
Information provided by (Responsible Party):
Magi Farre, Parc de Salut Mar
First received: June 21, 2012
Last updated: February 12, 2013
Last verified: June 2012
Slow continuous ultrafiltration using central vs peripheral line: feasibility of implementation, safety and efficacy in acute heart failure syndromes.
|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.
|Study Start Date:||November 2011|
|Estimated Study Completion Date:||January 2014|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
|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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01630317
|Contact: Nuria Ribas, MD||0034 93 248 email@example.com|
|Contact: Cristina Enjuanes, MD||0034 93 248 31 firstname.lastname@example.org|
|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