Mortality Reduction in Septic Shock by Plasma Adsorption (ROMPA)

Francisco Colomina Climent

Status: Terminated

Conditions: Septic Shock

Treatments: Device: High Doses CPFA

Study type: Interventional

Funder types: Other

Identifiers

NCT02357433

01-2015_R

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).

Enrollment: 55 patients

Sex: All

Ages: 18+ 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 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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55 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