Mortality Reduction in Septic Shock by Plasma Adsorption

Not Applicable

Terminated

• Conditions: Septic Shock
• Interventions: Device: High Doses CPFA

• Registration Number: NCT02357433
• Lead Sponsor: Francisco Colomina Climent

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-01-23
• Study Start: 2015-02
• Study First Submitted QC: 2015-02-02
• Study First Posted: 2015-02-06
• Primary Completion: 2018-06
• Study Completion: 2018-06
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-03
• Last Update Posted: 2018-07-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 55

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High doses CPFA	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

Primary Outcome Measures

Name	Time	Method
Hospital mortality	28 days

Secondary Outcome Measures

Name	Time	Method
time resolution of septic shock	within the first 28 days	normalization of lactate, and the decrease in vasoactive drugs

Trial Locations

Locations (10)

Hospital de la Plana; 🇪🇸 Villarreal, Castellon, Spain

Hospital Lluis Alcanyis; 🇪🇸 Xátiva, Valencia, Spain

Hospital Marina Baixa; 🇪🇸 Villajoyosa, Alicante, Spain

Hospital de Torrevieja; 🇪🇸 Torrevieja, Alicante, Spain

Hospital General Universitario de Santa Lucia; 🇪🇸 Cartagena, Murcia, Spain

Hospital Universitario de San Juan de Alicante; 🇪🇸 Sant Joan d'Alacant, Alicante, Spain

Hospital de Vinalopó; 🇪🇸 Elche, Alicante, Spain

Hospital de la Vega Baja; 🇪🇸 Orihuela, Alicante, Spain

Hospital Frances De Borja de Gandia; 🇪🇸 Gandia, Valencia, Spain

Hospital General Universitario de Alicante; 🇪🇸 Alicante, Spain