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

Shock, Septic Clinical Trial

— COMPACT-2  

Official title:

COMPACT (COMbining Plasma-filtration and Adsorption Clinical Trial): Efficacy and Safety of High Doses CPFA (Coupled Plasma Filtration Adsorption) for Septic Shock in the ICU

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01639664
• Other study ID #: 6233
• Status: Terminated
• Phase: N/A
• Start date: September 2013
• Est. completion date: October 23, 2017

Study information

• Verified date: March 2017
• Source: Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

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 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 115
• Est. completion date: October 23, 2017
• Est. primary completion date: October 23, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Shock
• Shock, Septic

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Italy	Ospedale SS. Antonio e Biagio e C. Arrigo, Servizio Anestesia, Rianimazione e Terapia Antalgica	Alessandria	Piemonte
Italy	Ospedale Maurizio Bufalini, UO Anestesia Terapia Intensiva	Cesena	Emilia Romagna
Italy	Ospedale Maggiore	Chieri	Piemonte
Italy	AOU Careggi	Firenze	Toscana
Italy	Ospedale Morgagni-Pierantoni, U.O. Anestesia e Rianimazione	Forlì	Emilia Romagna
Italy	Ospedale A. Manzoni, U.O. Anestesia e Rianimazione 1	Lecco	Lombardia
Italy	Ospedale Madonna delle Grazie, U.O. di Anestesia e Rianimazione	Matera	Basilicata
Italy	Ospedale Santa Croce	Moncalieri	Piemonte
Italy	Ospedali Riuniti Valdichiana Senese, U.O. di Anestesia e Rianimazione	Montepulciano	Toscana
Italy	Ospedale SS. Cosma e Damiano, Servizio Anestesia e Rianimazione	Pescia	Toscana
Italy	Ospedale Alta Val d'Elsa, Terapia Intensiva	Poggibonsi	Toscana
Italy	CTO Maria Adelaide, I Servizio Anestesia e Rianimazione	Torino	Piemonte
Italy	Ospedale San Giovanni Bosco, Servizio Anestesia e Rianimazione B-DEA	Torino	Piemonte

Sponsors (2)

Lead Sponsor	Collaborator
Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva	BELLCO Srl Mirandola (MO) ITALY

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At the discharge from the latest hospital (on average 30.3 days)
Secondary	Mortality Within 90 Days From Randomization		90 days from randomization
Secondary	ICU LOS Reduction Measured as Days Not Spent in the ICU During the First 30 Days From Randomization		30 days from randomization
Secondary	Septic Shock Resolution Measured as Number of Days Free of Vasoactive Drugs From Randomization		15 days from randomization

External Links

•   GiViTI web site