Slow Continuous Ultrafiltration Using Central vs Peripheral Line: Feasibility of Implementation, Safety and Efficacy in Acute Heart Failure Syndromes.
|ClinicalTrials.gov Identifier: NCT01630317|
Recruitment Status : Unknown
Verified April 2016 by Nuria Ribas, Parc de Salut Mar.
Recruitment status was: Active, not recruiting
First Posted : June 28, 2012
Last Update Posted : April 26, 2016
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure||Procedure: Peripheral line Procedure: Central line vein||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||33 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Slow Continuous Ultrafiltration Using Central vs Peripheral Line: Feasibility of Implementation, Safety and Efficacy in Acute Heart Failure Syndromes.|
|Study Start Date :||November 2011|
|Actual Primary Completion Date :||October 2013|
|Estimated Study Completion Date :||December 2016|
|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.
- 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
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01630317
|Cardiology Service, Hospital del Mar. Passeig Maritim 25-29,|
|Barcelona, Spain, 08003|