COMPACT - COMbining Plasma-filtration and Adsorption Clinical Trial

Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva184 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

184

Conditions

Shock, Septic

Interventions

CPFA (Coupled Plasma Filtration Adsorption)DEVICE

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.

Eligibility

Sex: ALLMin age: 18 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 18 years * Pregnancy * Cardiopulmonary resuscitation * Cerebral coma * Metastatic cancer * Presence of relative or absolute contraindications to CPFA * Estimated life expectancy less than 2 weeks * Already included in the study * Admission from an other ICU where the patient remained for more than 24 hours * Absence of informed consent

Locations (19)

Ospedale SS. Antonio e Biagio e C. Arrigo

Alessandria, AL, 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

Secondary Outcomes

Mortality within 90 days from randomization

Time frame: 90 days from randomization

New organ failures (assessed through SOFA score)

Time frame: Within ICU stay

Days not spent in the ICU during the first 30 days from randomization

Time frame: 30 days from randomization

Data from ClinicalTrials.gov

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