NCT00332371

COMPACT - COMbining Plasma-filtration and Adsorption Clinical Trial

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 184 (actual)
• Sponsor: Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Shock, Septic

Interventions

Type	Name	Description
DEVICE	CPFA (Coupled Plasma Filtration Adsorption)	CPFA is a specific method for the treatment of sepsis. It consists of: 1. a plasma-filter (polyethersulfone 0.45 m2 with a cutoff of approx 800 kDa) 2. a hemofilter (polyethersulfone 1,4 m2) 3. a cartridge (contains approximately 140 ml of hydrophobic styrenic resin) The kit is lodged in the Bellco "Lynda" machine (Bellco Mirandola, Italy). The treatment consists of the separation of plasma from the whole blood with adsorption of the inflammatory mediators and cytokines from the plasma, and a subsequent purification step by way of a hemofilter.

Timeline

• Start date: 2006-12-01
• Primary completion: 2010-12-01
• Completion: 2011-07-01
• First posted: 2006-06-01
• Last updated: 2012-07-09

Locations

19 sites across 1 country: Italy