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

Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva115 enrolled

Overview

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).

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

115

Conditions

Shock, Septic

Interventions

High doses CPFADEVICE

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.

Eligibility

Sex: ALLMin age: 14 Years

Medical Language ↔ Plain English

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

Locations (13)

Ospedale Madonna delle Grazie, U.O. di Anestesia e Rianimazione

Matera, Basilicate, Italy

Ospedale Maurizio Bufalini, UO Anestesia Terapia Intensiva

Cesena, Emilia-Romagna, Italy

Outcomes

Primary Outcomes

Hospital Mortality

For patients discharged to other hospital, it will be intended as mortality at the discharge from the latest hospital in which the patients stayed.

Time frame: At the discharge from the latest hospital (on average 30.3 days)

Secondary Outcomes

Mortality Within 90 Days From Randomization

Time frame: 90 days from randomization

ICU LOS Reduction Measured as Days Not Spent in the ICU During the First 30 Days From Randomization

Time frame: 30 days from randomization

Septic Shock Resolution Measured as Number of Days Free of Vasoactive Drugs From Randomization

Time frame: 15 days from randomization

Data from ClinicalTrials.gov

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