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NCT02357433 Clinical Trial

Mortality Reduction in Septic Shock by Plasma Adsorption

Septic Shock Clinical Trial

— ROMPA  

Official title:
Reduccion de la Mortalidad Mediante Plasma-Adsorción en Shock séptico (ROMPA)

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT02357433
Other study ID # 01-2015_R
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date February 2015
Est. completion date June 2018

Study information
Verified date July 2018
Source Hospital Universitario San Juan de Alicante
Contact n/a
Is FDA regulated No
Health authority
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).

Recruitment information / eligibility
Status Terminated
Enrollment 55
Est. completion date June 2018
Est. primary completion date June 2018
Accepts healthy volunteers No
Gender All
Age group 18 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 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

Related Conditions & MeSH terms

Intervention

Device:
• High Doses CPFA

Locations
Country Name City State
Spain Hospital General Universitario de Alicante Alicante
Spain Hospital General Universitario de Santa Lucia Cartagena Murcia
Spain Hospital de Vinalopó Elche Alicante
Spain Hospital Frances De Borja de Gandia Gandia Valencia
Spain Hospital de la Vega Baja Orihuela Alicante
Spain Hospital Universitario de San Juan de Alicante Sant Joan d'Alacant Alicante
Spain Hospital de Torrevieja Torrevieja Alicante
Spain Hospital Marina Baixa Villajoyosa Alicante
Spain Hospital de la Plana Villarreal Castellon
Spain Hospital Lluis Alcanyis Xátiva Valencia

Sponsors (1)
Lead Sponsor Collaborator
Francisco Colomina Climent

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Hospital mortality 28 days
Secondary time resolution of septic shock normalization of lactate, and the decrease in vasoactive drugs within the first 28 days
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