COMPACT - COMbining Plasma-filtration and Adsorption Clinical Trial

Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva

Status: Terminated

Conditions: Shock, Septic

Treatments: Device: CPFA (Coupled Plasma Filtration Adsorption)

Study type: Interventional

Funder types: Other

Identifiers

NCT00332371

ISRCTN24534559

4817

Details and patient eligibility

About

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).

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 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.

Enrollment: 184 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
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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184 participants in 2 patient groups

1

Experimental group

Treatment:

Device: CPFA (Coupled Plasma Filtration Adsorption)

2

No Intervention group