Mortality Reduction in Septic Shock by Plasma Adsorption

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2018-06-30

Brief Summary

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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).

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Detailed Description

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Conditions

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Septic Shock

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

High Doses CPFA

Intervention Type DEVICE

Control Group

Standard practice

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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High Doses CPFA

Intervention Type DEVICE

Eligibility Criteria

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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
* Estimated life expectancy (due to comorbidities) less than 90 days
* Presence of relative or absolute contraindications to CPFA
* Absence of informed consen

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No