Mortality Reduction in Septic Shock by Plasma Adsorption (ROMPA)

July 3, 2018 updated by: Francisco Colomina Climent

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

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

55

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Alicante, Spain, 03010
        • Hospital General Universitario de Alicante
    • Alicante
      • Elche, Alicante, Spain, 03293
        • Hospital de Vinalopó
      • Orihuela, Alicante, Spain, 03300
        • Hospital de La Vega Baja
      • Sant Joan d'Alacant, Alicante, Spain, 03550
        • Hospital Universitario de San Juan de Alicante
      • Torrevieja, Alicante, Spain, 03186
        • Hospital de Torrevieja
      • Villajoyosa, Alicante, Spain
        • Hospital Marina Baixa
    • Castellon
      • Villarreal, Castellon, Spain, 12540
        • Hospital de La Plana
    • Murcia
      • Cartagena, Murcia, Spain, 30202
        • Hospital General Universitario de Santa Lucia
    • Valencia
      • Gandia, Valencia, Spain
        • Hospital Frances De Borja de Gandia
      • Xátiva, Valencia, Spain, 46800
        • Hospital Lluis Alcanyis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Device: High Doses CPFA
No Intervention: Control Group
Standard practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Hospital mortality
Time Frame: 28 days
28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
time resolution of septic shock
Time Frame: within the first 28 days
normalization of lactate, and the decrease in vasoactive drugs
within the first 28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Francisco Colomina Climent

Investigators

  • Principal Investigator: Francisco Colomina, MD, Hospital Universitario de San Juan de Alicante

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Actual)

June 1, 2018

Study Completion (Actual)

June 1, 2018

Study Registration Dates

First Submitted

January 23, 2015

First Submitted That Met QC Criteria

February 2, 2015

First Posted (Estimate)

February 6, 2015

Study Record Updates

Last Update Posted (Actual)

July 6, 2018

Last Update Submitted That Met QC Criteria

July 3, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01-2015_R

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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