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

Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva

Status: Terminated

Conditions: Shock, Septic

Treatments: Device: High doses CPFA

Study type: Interventional

Funder types: Other

Identifiers

NCT01639664

6233

Details and patient eligibility

About

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).

Full 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).

Enrollment: 115 patients

Sex: All

Ages: 14+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All patients admitted to the ICU in septic shock
• All patients that develop septic shock while in the ICU

Exclusion criteria

• Age less than 14 years
• Pregnancy
• Estimated life expectancy (due to comorbidities) less than 90 days
• Presence of relative or absolute contraindications to CPFA
• Admission from an other ICU where the patient remained for more than 24 hours
• Absence of informed consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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115 participants in 2 patient groups

High doses CPFA

Experimental group

Description:

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.

Treatment:

Device: High doses CPFA

Control group

No Intervention group

Description:

standard practice