Slow Continuous Ultrafiltration Using Central vs Peripheral Line: Feasibility of Implementation, Safety and Efficacy in Acute Heart Failure Syndromes.
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|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|