NCT01639664

COMPACT 2 - COMbining Plasma-filtration and Adsorption Clinical Trial 2

COMPACT (COMbining Plasma-filtration and Adsorption Clinical Trial): Efficacy and Safety of High Doses CPFA (Coupled Plasma Filtration Adsorption) for Septic Shock in the ICU

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 115 (actual)
• Sponsor: Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva · Academic / Other
• Sex: All
• Age: 14 Years
• Healthy volunteers: Not accepted

Summary

The study objective is to clarify whether the application of high doses CPFA (coupled plasma-filtration adsorption) in addition to the current clinical practice is able to reduce hospital mortality in septic shock patients in intensive care unit (ICU).

Detailed description

Septic shock is a life-threatening clinical condition characterized by cardiovascular failure as a consequence of infection. Septic shock frequently causes multi-organ failure in the ICU. For this reason the extracorporeal therapies for the treatment of renal failure have become widespread in the ICU and, at the same time, new extracorporeal depurative techniques have been developed for the removal of inflammatory mediators. One of these techniques is CPFA (coupled plasma-filtration adsorption) that uses a sorbent once the separation between plasma and blood has been obtained with a plasma filter. The study objective is to clarify whether the application of high doses CPFA in addition to the current clinical practice is able to reduce hospital mortality in septic shock patients in intensive care unit. Secondary objectives are the resolution of septic shock and the reduction of ICU LOS (length of stay).

Conditions

• Shock, Septic

Interventions

Type	Name	Description
DEVICE	High doses CPFA	High doses CPFA (coupled plasma-filtration adsorption) with AMPLYA™ (BELLCO ITALY): \>0.20 L/kg/day of plasma treated in the first 3 days after randomization.

Timeline

• Start date: 2013-09-01
• Primary completion: 2017-10-23
• Completion: 2017-10-23
• First posted: 2012-07-13
• Last updated: 2021-09-05
• Results posted: 2021-09-05

Locations

13 sites across 1 country: Italy